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1. Outcome of Pancreatic Surgery During the First 6 Years of a Mandatory Audit Within the Dutch Pancreatic Cancer Group.

Author

Suurmeijer, J.A., Henry, A.C., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Harst, E. van der, Hingh, I.H. de, Intven, M.P., Kazemier, G., Wilmink, J.W., Lips, D.J., Wit, F., Meijer, V.E. de, Molenaar, I.Q., Patijn, G.A., Schelling, G.P. van der, Stommel, M.W.J., Busch, O.R., Groot Koerkamp, B., Santvoort, H.C. van, Besselink, M.G., Suurmeijer, J.A., Henry, A.C., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Harst, E. van der, Hingh, I.H. de, Intven, M.P., Kazemier, G., Wilmink, J.W., Lips, D.J., Wit, F., Meijer, V.E. de, Molenaar, I.Q., Patijn, G.A., Schelling, G.P. van der, Stommel, M.W.J., Busch, O.R., Groot Koerkamp, B., Santvoort, H.C. van, and Besselink, M.G.

Abstract

Item does not contain fulltext, OBJECTIVE: To describe outcome after pancreatic surgery in the first 6 years of a mandatory nationwide audit. BACKGROUND: Within the Dutch Pancreatic Cancer Group, efforts have been made to improve outcome after pancreatic surgery. These include collaborative projects, clinical auditing, and implementation of an algorithm for early recognition and management of postoperative complications. However, nationwide changes in outcome over time have not yet been described. METHODS: This nationwide cohort study included consecutive patients after pancreatoduodenectomy (PD) and distal pancreatectomy from the mandatory Dutch Pancreatic Cancer Audit (January 2014-December 2019). Patient, tumor, and treatment characteristics were compared between 3 time periods (2014-2015, 2016-2017, and 2018-2019). Short-term surgical outcome was investigated using multilevel multivariable logistic regression analyses. Primary endpoints were failure to rescue (FTR) and in-hospital mortality. RESULTS: Overall, 5345 patients were included, of whom 4227 after PD and 1118 after distal pancreatectomy. After PD, FTR improved from 13% to 7.4% [odds ratio (OR) 0.64, 95% confidence interval (CI) 0.50-0.80, P <0.001] and in-hospital mortality decreased from 4.1% to 2.4% (OR 0.68, 95% CI 0.54-0.86, P =0.001), despite operating on more patients with age >75 years (18%-22%, P =0.006), American Society of Anesthesiologists score ≥3 (19%-31%, P <0.001) and Charlson comorbidity score ≥2 (24%-34%, P <0.001). The rates of textbook outcome (57%-55%, P =0.283) and major complications remained stable (31%-33%, P =0.207), whereas complication-related intensive care admission decreased (13%-9%, P =0.002). After distal pancreatectomy, improvements in FTR from 8.8% to 5.9% (OR 0.65, 95% CI 0.30-1.37, P =0.253) and in-hospital mortality from 1.6% to 1.3% (OR 0.88, 95% CI 0.45-1.72, P =0.711) were not statistically significant. CONCLUSIONS: During the first 6 years of a nationwide audit, in-hospital mortality and FTR af

Published
2023

2. Outcomes of a Multicenter Training Program in Robotic Pancreatoduodenectomy (LAELAPS-3)

Author

Zwart, M.J.W., Nota, C.L.M., Rooij, T. de, Hilst, J. van, Riele, W.W. te, Santvoort, H.C. van, Hagendoorn, J., Rinkes, I.H.M.B., Dam, J.L. van, Latenstein, A.E.J., Takagi, K., Tran, K.T.C., Schreinemakers, J., Schelling, G.P. van der, Wijsman, J.H., Festen, S., Daams, F., Luyer, M.D., Hingh, I.H.J.T. de, Mieog, J.S.D., Bonsing, B.A., Lips, D.J., Abu Hilal, M., Busch, O.R., Saint-Marc, O., Zehl, H.J.Z., Zureikat, A.H., Hogg, M.E., Molenaar, I.Q., Besselink, M.G., Koerkamp, B.G., Dutch Pancreatic Canc Grp, Graduate School, CCA - Cancer Treatment and Quality of Life, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Anesthesiology, APH - Quality of Care, Surgery, CCA - Cancer Treatment and quality of life, and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
complication, Robotics, Pancreaticoduodenectomy, Pancreatic Neoplasms, Pancreatic Fistula, Postoperative Complications, learning curve, robotic pancreatoduodectomy, Robotic Surgical Procedures, SDG 3 - Good Health and Well-being, robotic surgery, Humans, Laparoscopy, Surgery, Retrospective Studies, operative time
Abstract

OBJECTIVE: To assess feasibility and safety of a multicenter training program in robotic pancreatoduodenectomy (RPD) adhering to the IDEAL framework for implementation of surgical innovation.BACKGROUND: Good results for RPD have been reported from single center studies. However, data on feasibility and safety of implementation through a multicenter training program in RPD are lacking.METHODS: A multicenter training program in RPD was designed together with the University of Pittsburgh Medical Center, including an online video bank, robot simulation exercises, biotissue drills, and on-site proctoring. Benchmark patients were based on the criteria of Clavien. Outcomes were collected prospectively (March 2016-October 2019). Cumulative sum (CUSUM) analysis of operative time was performed to distinguish the first and second phase of the learning curve. Outcomes were compared between both phases of the learning curve. Trends in nationwide use of robotic and laparoscopic PD were assessed in the Dutch Pancreatic Cancer Audit.RESULTS: Overall, 275 RPD procedures were performed in seven centers by 15 trained surgeons. The recent benchmark criteria for low-risk PD were met by 125 (45.5%) patients. The conversion rate was 6.5% (n = 18) and median blood loss 250 ml (IQR 150-500). The rate of Clavien-Dindo grade ≥III complications was 44.4% (n = 122), postoperative pancreatic fistula (grade B/C) rate 23.6% (n = 65), 90-day complication-related mortality 2.5% (n = 7) and 90-day cancer-related mortality 2.2.% (n = 6). Median postoperative hospital stay was 12 days (IQR 8-20). In the subgroup of patients with pancreatic cancer (n = 80), the major complication rate was 31.3% and POPF rate was 10%. CUSUM analysis for operative time found a learning curve inflection point at 22 RPDs (IQR 10-35) with similar rates of Clavien-Dindo grade ≥III complications in the first and second phase (43.4% vs 43.8%, P = 0.956, respectively). During the study period the nationwide use of laparoscopic PD reduced from 15% to 1%, whereas the use of RPD increased from 0% to 25%.CONCLUSIONS: This multicenter RPD training program in centers with sufficient surgical volume was found to be feasible without a negative impact of the learning curve on clinical outcomes.

Published
2021

3. The risk of not receiving adjuvant chemotherapy after resection of pancreatic ductal adenocarcinoma

Author

Mackay, T.M., Smits, F.J., Roos, D., Bonsing, B.A., Bosscha, K., Busch, O.R., Creemers, G.J., Dam, R.M. van, Eijck, C.H.J. van, Gerhards, M.F., Groot, J.W.B. de, Koerkamp, B.G., Mohammad, N.H., Harst, E. van der, Hingh, I.H.J.T. de, Homs, M.Y.V., Kazemier, G., Liem, M.S.L., Meijer, V.E. de, Molenaar, I.Q., Nieuwenhuijs, V.B., Santvoort, H.C. van, Schelling, G.P. van der, Stommel, M.W.J., Tije, A.J. ten, Vos-Geelen, J. de, Wit, F., Wilmink, J.W., Laarhoven, H.W.M. van, Besselink, M.G., Dutch Pancreatic Canc Grp, Graduate School, AGEM - Digestive immunity, AGEM - Endocrinology, metabolism and nutrition, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and Quality of Life, Surgery, Oncology, CCA - Cancer Treatment and quality of life, Medical Oncology, Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM), RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Male, SURGERY, medicine.medical_treatment, INTERNATIONAL STUDY-GROUP, 030230 surgery, SURGICAL COMPLICATIONS, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Risk Factors, Odds Ratio, Hospital Mortality, POSTOPERATIVE COMPLICATIONS, Netherlands, Gastroenterology, Age Factors, Middle Aged, Pancreaticoduodenectomy, OPEN-LABEL, CANCER, Pancreatic fistula, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, PANCREATICODUODENECTOMY, Female, medicine.drug, Carcinoma, Pancreatic Ductal, medicine.medical_specialty, Hospitals, Low-Volume, 03 medical and health sciences, Pancreatectomy, Pancreatic cancer, medicine, Journal Article, Humans, Aged, Retrospective Studies, Chemotherapy, Performance status, Hepatology, business.industry, MORTALITY, Postoperative complication, Odds ratio, medicine.disease, Gemcitabine, Surgery, Pancreatic Neoplasms, Logistic Models, DEFINITION, GEMCITABINE, Neoplasm Grading, business
Abstract

Contains fulltext : 226028.pdf (Publisher’s version ) (Closed access) BACKGROUND: The relation between type of postoperative complication and not receiving chemotherapy after resection of pancreatic ductal adenocarcinoma (PDAC) is unclear. The aim was to investigate which patient factors and postoperative complications were associated with not receiving adjuvant chemotherapy. METHODS: Patients who underwent resection (2014-2017) for PDAC were identified from the nationwide mandatory Dutch Pancreatic Cancer Audit. The association between patient-, tumor-, center-, treatment characteristics, and the risk of not receiving adjuvant chemotherapy was analyzed with multivariable logistic regression. RESULTS: Overall, of 1306 patients, 24% (n = 312) developed postoperative Clavien Dindo ≥3 complications. In-hospital mortality was 3.5% (n = 46). Some 433 patients (33%) did not receive adjuvant chemotherapy. Independent predictors (all p

Published
2020

4. Textbook Outcome

Author

Roessel, S. van, Mackay, T.M., Dieren, S. van, Schelling, G.P. van der, Nieuwenhutjs, V.B., Bosscha, K., Harst, E. van der, Dam, R.M. van, Liem, M.S.L., Festen, S., Stommel, M.W.J., Roos, D., Wit, F., Molenaar, I.Q., Meijer, V.E. de, Kazemier, G., Hingh, I.H.J.T. de, Santvoort, H.C. van, Bonsing, B.A., Busch, O.R., Koerkamp, B.G., Besselink, M.G., Dutch Pancreatic Canc Grp, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), Graduate School, CCA - Cancer Treatment and Quality of Life, AGEM - Digestive immunity, AGEM - Endocrinology, metabolism and nutrition, AGEM - Re-generation and cancer of the digestive system, Surgery, and APH - Methodology

Subjects
Male, INDICATORS, medicine.medical_treatment, INTERNATIONAL STUDY-GROUP, Logistic regression, outcomes, Gastroenterology, surgery, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Postoperative Complications, MARGIN STATUS, Medicine, IN-HOSPITAL MORTALITY, Hospital Mortality, Registries, Textbooks as Topic, pancreatic surgery, Neoadjuvant therapy, Netherlands, Response rate (survey), major complications, Incidence (epidemiology), Incidence, Middle Aged, medicine.anatomical_structure, textbook outcome, Pancreatic fistula, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, medicine.medical_specialty, germany, CLASSIFICATION, Pancreaticoduodenectomy, 03 medical and health sciences, Pancreatectomy, Pancreatic cancer, Internal medicine, Humans, fistula, care, Aged, Quality Indicators, Health Care, Retrospective Studies, Pancreatic duct, COMPOSITE-MEASURE, business.industry, Retrospective cohort study, medicine.disease, auditing, Pancreatic Neoplasms, business, practice variation
Abstract

Contains fulltext : 226022.pdf (Publisher’s version ) (Closed access) BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates. RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment. CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

Published
2020

5. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery

Author

Roessel, S. van, Mackay, T.M., Dieren, S. van, Schelling, G.P. van der, Nieuwenhuijs, V.B., Bosscha, K., Harst, E, Dam, R.M. van, Liem, M.S., Festen, S., Stommel, M.W.J., Roos, D., Wit, F., Molenaar, I.Q., Meijer, V.E. de, Kazemier, G., Hingh, I. de, Santvoort, H.C. van, Bonsing, B.A., Busch, O.R., Koerkamp, B. Groot, Besselink, M.G.H., Roessel, S. van, Mackay, T.M., Dieren, S. van, Schelling, G.P. van der, Nieuwenhuijs, V.B., Bosscha, K., Harst, E, Dam, R.M. van, Liem, M.S., Festen, S., Stommel, M.W.J., Roos, D., Wit, F., Molenaar, I.Q., Meijer, V.E. de, Kazemier, G., Hingh, I. de, Santvoort, H.C. van, Bonsing, B.A., Busch, O.R., Koerkamp, B. Groot, and Besselink, M.G.H.

Abstract

Contains fulltext : 226022.pdf (Publisher’s version ) (Closed access), BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates. RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment. CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

Published
2020

6. The risk of not receiving adjuvant chemotherapy after resection of pancreatic ductal adenocarcinoma: a nationwide analysis

Author

Mackay, T.M., Smits, F.J., Roos, D., Bonsing, B.A., Bosscha, K., Busch, O.R., Creemers, G.J., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Groot, J.W.B. de, Groot Koerkamp, B., Mohammad, N. Haj, Harst, E, Hingh, I. de, Homs, M.Y.V., Kazemier, G., Liem, M.S., Meijer, V.E. de, Molenaar, I.Q., Nieuwenhuijs, V.B., Santvoort, H.C. van, Schelling, G.P. van der, Stommel, M.W.J., Tije, A.J. Ten, Vos-Geelen, J. de, Wit, F., Wilmink, J.W., Laarhoven, H.W. van, Besselink, M.G.H., Mackay, T.M., Smits, F.J., Roos, D., Bonsing, B.A., Bosscha, K., Busch, O.R., Creemers, G.J., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Groot, J.W.B. de, Groot Koerkamp, B., Mohammad, N. Haj, Harst, E, Hingh, I. de, Homs, M.Y.V., Kazemier, G., Liem, M.S., Meijer, V.E. de, Molenaar, I.Q., Nieuwenhuijs, V.B., Santvoort, H.C. van, Schelling, G.P. van der, Stommel, M.W.J., Tije, A.J. Ten, Vos-Geelen, J. de, Wit, F., Wilmink, J.W., Laarhoven, H.W. van, and Besselink, M.G.H.

Abstract

Contains fulltext : 226028.pdf (Publisher’s version ) (Closed access), BACKGROUND: The relation between type of postoperative complication and not receiving chemotherapy after resection of pancreatic ductal adenocarcinoma (PDAC) is unclear. The aim was to investigate which patient factors and postoperative complications were associated with not receiving adjuvant chemotherapy. METHODS: Patients who underwent resection (2014-2017) for PDAC were identified from the nationwide mandatory Dutch Pancreatic Cancer Audit. The association between patient-, tumor-, center-, treatment characteristics, and the risk of not receiving adjuvant chemotherapy was analyzed with multivariable logistic regression. RESULTS: Overall, of 1306 patients, 24% (n = 312) developed postoperative Clavien Dindo ≥3 complications. In-hospital mortality was 3.5% (n = 46). Some 433 patients (33%) did not receive adjuvant chemotherapy. Independent predictors (all p < 0.050) for not receiving adjuvant chemotherapy were older age (odds ratio (OR) 0.96), higher ECOG performance status (OR 0.57), postoperative complications (OR 0.32), especially grade B/C pancreatic fistula (OR 0.51) and post-pancreatectomy hemorrhage (OR 0.36), poor tumor differentiation grade (OR 0.62), and annual center volume of <40 pancreatoduodenectomies (OR 0.51). CONCLUSIONS: This study demonstrated that a third of patients do not receive chemotherapy after resection of PDAC. Next to higher age, worse performance status and lower annual surgical volume, this is mostly related to surgical complications, especially postoperative pancreatic fistula and post-pancreatectomy hemorrhage.

Published
2020

7. Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study)

Author

Barendse, R.M., Musters, G.D., Graaf, E.J.R. de, Broek, F.J.C. van den, Consten, E.C.J., Doornebosch, P.G., Hardwick, J.C., Hingh, I.H.J.T. de, Hoff, C., Jansen, J.M., Wit, A.W.M.V. de, Schelling, G.P. van der, Schoon, E.J., Schwartz, M.P., Weusten, B.L.A.M., Dijkgraaf, M.G., Fockens, P., Bemelman, W.A., Dekker, E., TREND Study Grp, CCA - Cancer Treatment and quality of life, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, CCA - Cancer Treatment and Quality of Life, Other departments, Gastroenterology and Hepatology, APH - Methodology, Clinical Research Unit, and APH - Quality of Care

Subjects
Adenoma, Male, Transanal Endoscopic Microsurgery, medicine.medical_specialty, Endoscopic Mucosal Resection, Cost effectiveness, medicine.medical_treatment, Cost-Benefit Analysis, health care facilities, manpower, and services, Endoscopic mucosal resection, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Belgium, law, health services administration, Medicine, Humans, Major complication, health care economics and organizations, Aged, Netherlands, business.industry, Rectal Neoplasms, Gastroenterology, Cancer, Microsurgery, Middle Aged, medicine.disease, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Quality of Life, 030211 gastroenterology & hepatology, Female, Neoplasm Recurrence, Local, Complication, business, Precancerous Conditions, Follow-Up Studies
Abstract

ObjectiveNon-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas.DesignPatients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital.ResultsTwo hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective.ConclusionUnder the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

Published
2018

8. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS) Design and International External Validation

Author

Mungroop, T.H., Rijssen, L.B. van, Klaveren, D. van, Smits, F.J., Woerden, V. van, Linnemann, R.J., Pastena, M. de, Klompmaker, S., Marchegiani, G., Ecker, B.L., Dieren, S. van, Bonsing, B., Busch, O.R., Dam, R.M. van, Erdmann, J., Eijck, C.H. van, Gerhards, M.E., Goor, H. van, Harst, E. van der, Hingh, I.H. de, Jong, K.P. de, Kazemier, G., Luyer, M., Shamali, A., Barbaro, S., Armstrong, T., Takhar, A., Hamady, Z., Klaase, J., Lips, D.J., Molenaar, I.Q., Nieuwenhuijs, V.B., Rupert, C., Santvoort, H.C. van, Scheepers, J.J., Schelling, G.P. van der, Bassi, C., Vollmer, C.M., Steyerberg, E.W., Abu Hilal, M., Koerkamp, B.G., Besselink, M.G., Dutch Pancreatic Canc Grp, Ear, Nose and Throat, CCA - Cancer Treatment and Quality of Life, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, AGEM - Endocrinology, metabolism and nutrition, Graduate School, Surgery, APH - Methodology, Promovendi NTM, MUMC+: MA Heelkunde (9), RS: NUTRIM - R2 - Liver and digestive health, CCA - Cancer Treatment and quality of life, Groningen Institute for Organ Transplantation (GIOT), Guided Treatment in Optimal Selected Cancer Patients (GUTS), Value, Affordability and Sustainability (VALUE), and Public Health

Subjects
Male, medicine.medical_specialty, Internationality, LOGISTIC-REGRESSION ANALYSIS, PREDICTION, DRAINAGE, Fistula, medicine.medical_treatment, MODELS, complication, 030230 surgery, Gastroenterology, Risk Assessment, Pancreaticoduodenectomy, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, pancreatic fistula, BLOOD-LOSS, Internal medicine, Pancreatic cancer, POSTOPERATIVE PANCREATIC FISTULA, medicine, MANAGEMENT, Humans, pancreas, Aged, Pancreatic duct, Framingham Risk Score, business.industry, Odds ratio, PERFORMANCE, Middle Aged, medicine.disease, Confidence interval, prediction model, medicine.anatomical_structure, Pancreatic fistula, 030220 oncology & carcinogenesis, Surgery, Female, Pancreatic Fistula, business, SYSTEM
Abstract

Objective: The aim of this study was to develop an alternative fistula risk score (a-FRS) for postoperative pancreatic fistula (POPF) after pancreatoduodenectomy, without blood loss as a predictor.Background: Blood loss, one of the predictors of the original-FRS, was not a significant factor during 2 recent external validations.Methods: The a-FRS was developed in 2 databases: the Dutch Pancreatic Cancer Audit (18 centers) and the University Hospital Southampton NHS. Primary outcome was grade B/C POPF according to the 2005 International Study Group on Pancreatic Surgery (ISGPS) definition. The score was externally validated in 2 independent databases (University Hospital of Verona and University Hospital of Pennsylvania), using both 2005 and 2016 ISGPS definitions. The a-FRS was also compared with the original-FRS.Results: For model design, 1924 patients were included of whom 12% developed POPE Three predictors were strongly associated with POPF: soft pancreatic texture [odds ratio (OR) 2.58, 95% confidence interval (95% CI) 1.80-3.69], small pancreatic duct diameter (per mm increase, OR: 0.68, 95% CI: 0.61-0.76), and high body mass index (BMI) (per kg/m(2) increase, OR: 1.07, 95% CI: 1.04-1.11). Discrimination was adequate with an area under curve (AUC) of 0.75 (95% CI: 0.71-0.78) after internal validation, and 0.78 (0.74-0.82) after external validation. The predictive capacity of a-FRS was comparable with the original-FRS, both for the 2005 definition (AUC 0.78 vs 0.75, P = 0.03), and 2016 definition (AUC 0.72 vs 0.70, P = 0.05).Conclusion: The a-FRS predicts POPF after pancreatoduodenectomy based on 3 easily available variables (pancreatic texture, duct diameter, BMI) without blood loss and pathology, and was successfully validated for both the 2005 and 2016 POPF definition. The online calculator is available at www.pancreascalculator.com .

Published
2019

9. Outcomes of Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma in the Netherlands: A Nationwide Retrospective Analysis

Author

Rooij, T. de, Tol, J.A., Eijck, C.H. van, Boerma, D., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Dijkgraaf, M.G., Gerhards, M.F., Goor, H. van, Harst, E. van der, Hingh, I.H. de, Kazemier, G., Klaase, J.M., Molenaar, I.Q., Patijn, G.A., Santvoort, H.C. van, Scheepers, J.J., Schelling, G.P. van der, Sieders, E., Busch, O.R., Besselink, M.G., Dutch Pancreatic Canc Grp, RS: FHML non-thematic output, MUMC+: MA Heelkunde (9), Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Clinical Research Unit, and CCA - Clinical Therapy Development

Subjects
Adult, Male, medicine.medical_specialty, endocrine system diseases, medicine.medical_treatment, Adenocarcinoma, 030230 surgery, Gastroenterology, 03 medical and health sciences, Pancreatectomy, 0302 clinical medicine, Internal medicine, medicine, Carcinoma, Humans, Neoplasm Invasiveness, Survival rate, Aged, Neoplasm Staging, Netherlands, Retrospective Studies, business.industry, Incidence, Cancer, Pancreatic Tumors, Retrospective cohort study, Middle Aged, Prognosis, medicine.disease, Pancreaticoduodenectomy, digestive system diseases, Pancreatic Neoplasms, Survival Rate, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Oncology, 030220 oncology & carcinogenesis, Female, Lymphadenectomy, Surgery, business, Carcinoma, Pancreatic Ductal, Follow-Up Studies
Abstract

Contains fulltext : 168590.pdf (Publisher’s version ) (Open Access) BACKGROUND: Large multicenter series on outcomes and predictors of survival after distal pancreatectomy (DP) for pancreatic ductal adenocarcinoma (PDAC) are scarce. METHODS: Adults who underwent DP for PDAC in 17 Dutch pancreatic centers between January 2005 and September 2013 were analyzed retrospectively. The primary outcome was survival, and predictors of survival were identified using Cox regression analysis. RESULTS: In total, 761 consecutive patients after DP were assessed, of whom 620 patients were excluded because of non-PDAC histopathology (n = 616) or a lack of data (n = 4), leaving a total of 141 patients included in the study [45 % (n = 63) male, mean age 64 years (SD = 10)]. Multivisceral resection was performed in 43 patients (30 %) and laparoscopic resection was performed in 7 patients (5 %). A major complication (Clavien-Dindo score of III or higher) occurred in 46 patients (33 %). Mean tumor size was 44 mm (SD 23), and histopathological examination showed 70 R0 resections (50 %), while 30-day and 90-day mortality was 3 and 6 %, respectively. Overall, 63 patients (45 %) received adjuvant chemotherapy. Median survival was 17 months [interquartile range (IQR) 13-21], with a median follow-up of 17 months (IQR 8-29). Cumulative survival at 1, 3 and 5 years was 64, 29, and 22 %, respectively. Independent predictors of worse postoperative survival were R1/R2 resection [hazard ratio (HR) 1.6, 95 % confidence interval (CI) 1.1-2.4], pT3/pT4 stage (HR 1.9, 95 % CI 1.3-2.9), a major complication (HR 1.7, 95 % CI 1.1-2.5), and not receiving adjuvant chemotherapy (HR 1.5, 95 % CI 1.0-2.3). CONCLUSION: Survival after DP for PDAC is poor and is related to resection margin, tumor stage, surgical complications, and adjuvant chemotherapy. Further studies should assess to what extent prevention of surgical complications and more extensive use of adjuvant chemotherapy can improve survival.

Published
2016

10. A Nationwide Comparison of Laparoscopic and Open Distal Pancreatectomy for Benign and Malignant Disease

Author

Rooij, T. de, Jilesen, A.P., Boerma, D., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Dieren, S. van, Dijkgraaf, M.G., Eijck, C.H. van, Gerhards, M.F., Goor, H. van, Harst, E. van der, Hingh, I.H. de, Kazemier, G., Klaase, J.M., Molenaar, I.Q., Dijkum, E.J.N. van, Patijn, G.A., Santvoort, H.C. van, Scheepers, J.J., Schelling, G.P. van der, Sieders, E., Vogel, J.A., Busch, O.R., Besselink, M.G., Dutch Pancreatic Canc Grp, Surgery, CCA - Innovative therapy, RS: NUTRIM - R2 - Gut-liver homeostasis, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Other departments, Amsterdam Public Health, Clinical Research Unit, Other Research, Graduate School, and 02 Surgical specialisms

Subjects
Adult, Male, medicine.medical_specialty, Attitude of Health Personnel, medicine.medical_treatment, Pancreatectomy, Postoperative Complications, Interquartile range, Medicine, Humans, Propensity Score, Aged, Netherlands, Surgeons, Intention-to-treat analysis, business.industry, General surgery, Pancreatic Diseases, Odds ratio, Length of Stay, Middle Aged, Pancreaticoduodenectomy, Surgery, Intention to Treat Analysis, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, Health Care Surveys, Propensity score matching, Cohort, Female, Laparoscopy, business, Cohort study, Abdominal surgery
Abstract

Item does not contain fulltext BACKGROUND: Cohort studies from expert centers suggest that laparoscopic distal pancreatectomy (LDP) is superior to open distal pancreatectomy (ODP) regarding postoperative morbidity and length of hospital stay. But the generalizability of these findings is unknown because nationwide data on LDP are lacking. STUDY DESIGN: Adults who had undergone distal pancreatectomy in 17 centers between 2005 and 2013 were analyzed retrospectively. First, all LDPs were compared with all ODPs. Second, groups were matched using a propensity score. Third, the attitudes of pancreatic surgeons toward LDP were surveyed. The primary outcome was major complications (Clavien-Dindo grade >/=III). RESULTS: Among 633 included patients, 64 patients (10%) had undergone LDP and 569 patients (90%) had undergone ODP. Baseline characteristics were comparable, except for previous abdominal surgery and mean tumor size. In the full cohort, LDP was associated with fewer major complications (16% vs 29%; p = 0.02) and a shorter median [interquartile range, IQR] hospital stay (8 days [7-12 days] vs 10 days [8-14 days]; p = 0.03). Of all LDPs, 33% were converted to ODP. Matching succeeded for 63 LDP patients. After matching, the differences in major complications (9 patients [14%] vs 19 patients [30%]; p = 0.06) and median [IQR] length of hospital stay (8 days [7-12 days] vs 10 days [8-14 days]; p = 0.48) were not statistically significant. The survey demonstrated that 85% of surgeons welcomed LDP training. CONCLUSIONS: Despite nationwide underuse and an impact of selection bias, outcomes of LDP seemed to be at least noninferior to ODP. Specific training is welcomed and could improve both the use and outcomes of LDP. 01 maart 2015

Published
2015

11. Variation in hospital mortality after pancreatoduodenectomy is related to failure to rescue rather than major complications: a nationwide audit

Author

Rijssen, L.B. van, Zwart, M.J., Dieren, S. van, Rooij, T. de, Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Gerritsen, J.J., Harst, E, Hingh, I.H. de, Jong, K.P. de, Kazemier, G., Klaase, J., Kolk, B.M. van der, Laarhoven, C.J.H.M. van, Luyer, M.D., Molenaar, I.Q., Patijn, G.A., Rupert, C.G., Scheepers, J.J., Schelling, G.P. van der, Vahrmeijer, A.L., Busch, O.R., Santvoort, H.C. van, Koerkamp, B. Groot, Besselink, M.G.H., Rijssen, L.B. van, Zwart, M.J., Dieren, S. van, Rooij, T. de, Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Gerritsen, J.J., Harst, E, Hingh, I.H. de, Jong, K.P. de, Kazemier, G., Klaase, J., Kolk, B.M. van der, Laarhoven, C.J.H.M. van, Luyer, M.D., Molenaar, I.Q., Patijn, G.A., Rupert, C.G., Scheepers, J.J., Schelling, G.P. van der, Vahrmeijer, A.L., Busch, O.R., Santvoort, H.C. van, Koerkamp, B. Groot, and Besselink, M.G.H.

Abstract

Item does not contain fulltext, BACKGROUND: In the mandatory nationwide Dutch Pancreatic Cancer Audit, rates of major complications and Failure to Rescue (FTR) after pancreatoduodenectomy between low- and high-mortality hospitals are compared, and independent predictors for FTR investigated. METHODS: Patients undergoing pancreatoduodenectomy in 2014 and 2015 in The Netherlands were included. Hospitals were divided into quartiles based on mortality rates. The rate of major complications (Clavien-Dindo >/=3) and death after a major complication (FTR) were compared between these quartiles. Independent predictors for FTR were identified by multivariable logistic regression analysis. RESULTS: Out of 1.342 patients, 391 (29%) developed a major complication and in-hospital mortality was 4.2%. FTR occurred in 56 (14.3%) patients. Mortality was 0.9% in the first hospital quartile (4 hospitals, 327 patients) and 8.1% in the fourth quartile (5 hospitals, 310 patients). The rate of major complications increased by 40% (25.7% vs 35.2%) between the first and fourth hospital quartile, whereas the FTR rate increased by 560% (3.6% vs 22.9%). Independent predictors of FTR were male sex (OR = 2.1, 95%CI 1.2-3.9), age >75 years (OR = 4.3, 1.8-10.2), BMI >/=30 (OR = 2.9, 1.3-6.6), histopathological diagnosis of periampullary cancer (OR = 2.0, 1.1-3.7), and hospital volume <30 (OR = 3.9, 1.6-9.6). CONCLUSIONS: Variations in mortality between hospitals after pancreatoduodenectomy were explained mainly by differences in FTR, rather than the incidence of major complications.

Published
2018

12. Benchmarking recent national practice in rectal cancer treatment with landmark randomized controlled trials

Author

Borstlap, W.A., Deijen, C.L., Dulk, M. den, Bonjer, H.J., Velde, C.J. van de, Bemelman, W.A., Tanis, P.J., Aalbers, A., Acherman, Y., Algie, G.D., Geu-sau, B. von, Amelung, F., Aukema, T.S., Bakker, I.S., Bartels, S.A., Basha, S., Bastiaansen, A.J., Belgers, E.H.J., Bleeker, W., Blok, J., Bosker, R.J.I., Bosmans, J.W., Boute, M.C., Bouvy, N.D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D.J., Bruin, S., Bruns, E.R.J., Burbach, J.P.M., Burger, J.W., Buskens, C.J., Clermonts, S., Coene, P.P.L.O., Compaan, C., Consten, E.C., Darbyshire, T., Mik, S.M.L. de, Graaf, E.J. de, Groot, I de, Cappel de Vos Tot Nederveen, R.J.L., Wilt, J.H.W. de, Wolde, J. van der, Boer, F.C. den, Dekker, J.W.T., Demirkiran, A., Derkx-Hendriksen, M., Dijkstra, F.R., Duijvendijk, P. van, Dunker, M.S., Eijsbouts, Q.E., Fabry, H., Ferenschild, F.T.J., Foppen, J.W., Furnee, E.J.B., Gerhards, M.F., Gerven, P, Gooszen, J.A.H., Govaert, J.A., Grevenstein, W.M. van, Haen, R., Harlaar, J.J., Harst, E, Havenga, K., Heemskerk, J., Heeren, J.F., Heijnen, B., Heres, P., Hoff, C., Hogendoorn, W., Hoogland, P., Huijbers, A, Janssen, P., Jongen, A.C., Jonker, F.H., Karthaus, E.G., Keijzer, A, Ketel, J.M.A., Klaase, J., Kloppenberg, F.W.H., Kool, M.E., Kortekaas, R., Kruyt, P.M., Kuiper, J.T., Lamme, B., Lange, J.F., Lettinga, T., Lips, D.J., Logeman, F., Holzik, M.F., Madsen, E., Mamound, A., Marres, C.C., Masselink, I., Meerdink, M., Menon, A.G., Mieog, J.S., Mierlo, D. van, Musters, G.D., Neijenhuis, P.A., Nonner, J., Oostdijk, M, Oosterling, S.J., Paul, P.M.P., Peeters, K.C., Pereboom, I.T.A., Polat, F., Poortman, P., Raber, M., Reiber, B.M.M., Renger, R.J., Rossem, C.C. van, Rutten, H.J., Rutten, A., Schaapman, R., Scheer, M.G.W., Schoonderwoerd, L., Schouten, N., Schreuder, A.M., Schreurs, W.H., Simkens, G.A., Slooter, G.D., Sluijmer, H.C.E., Smakman, N., Smeenk, R., Snijders, H.S., Sonneveld, D.J.A., Spaansen, B., Spillenaar Bilgen, E.J., Steller, E., Steup, W.H., Steur, C., Stortelder, E., Straatman, J., Swank, H.A., Sietses, C., Berge, H.A. ten, Hoeve, H.G. ten, Riele, W.W. ter, Thorensen, I.M., Tip-Pluijm, B., Toorenvliet, B.R., Tseng, L., Tuynman, J.B., Bastelaar, J. van, Beek, S.V. van, Ven, A.W.H. van de, Weijer, M.A.J. van de, Berg, C. van den, Bosch, I. van den, Bilt, J.D.W. van der, Hagen, S.J. van der, Hul, R. van der, Schelling, G.P. van der, Spek, A van der, Wielen, N. van der, Duyn, E. van, Eekelen, C. van, Essen, J.A. van, Gangelt, K. van, Geloven, A.A. van, Kessel, C. Van, Loon, Y.T. van, Rijswijk, A. van, Rooijen, S.J. van, Sprundel, T. van, Steensel, L. van, Tets, W.F van, Westreenen, H.L. van, Veltkamp, S., Verhaak, T., Verheijen, P.M., Versluis-Ossenwaarde, L., Vijfhuize, S., Vles, W.J., Voeten, S., Vogelaar, F.J., Vrijland, W.W., Westerduin, E., Westerterp, M., Wetzel, M., Wevers, K., Wiering, B., Witjes, A.C., Wouters, M.W., Yauw, S.T.K., Zeestraten, E.C., Zimmerman, D., Zwieten, T., Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Surgery, CCA - Cancer Treatment and quality of life, APH - Quality of Care, APH - Global Health, Anatomy and neurosciences, VU University medical center, AGEM - Re-generation and cancer of the digestive system, AGEM - Digestive immunity, Neurology, Internal medicine, ACS - Microcirculation, MUMC+: MA Heelkunde (9), RS: MHeNs - R2 - Mental Health, Psychiatrie & Neuropsychologie, Promovendi MHN, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, RS: NUTRIM - R1 - Metabolic Syndrome, RS: NUTRIM - R2 - Liver and digestive health, Revalidatie, RS: CARIM - R1.03 - Cell biochemistry of thrombosis and haemostasis, Biochemie, Promovendi CD, Ondersteunend personeel NTM, Promovendi NTM, Promovendi PHPC, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA AIOS Heelkunde (9), Promovendi ODB, MUMC+: MA AIOS Anesthesiologie (9), Pathologie, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Cancer Treatment and Quality of Life, Graduate School, and Other departments

Subjects
Male, Transanal Endoscopic Microsurgery, Colorectal cancer, medicine.medical_treatment, NETHERLANDS, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, ADJUVANT CHEMOTHERAPY, Randomized controlled trial, law, Interquartile range, Prospective Studies, Registries, Rectal cancer, Intersectoral Collaboration, Randomized Controlled Trials as Topic, Aged, 80 and over, Medical Audit, Gastroenterology, Margins of Excision, Chemoradiotherapy, Benchmarking, Middle Aged, Total mesorectal excision, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, snapshot study, 030220 oncology & carcinogenesis, OPEN SURGERY, Cohort, Female, 030211 gastroenterology & hepatology, RADIOTHERAPY, medicine.medical_specialty, Disease-Free Survival, 03 medical and health sciences, ANTERIOR RESECTION, medicine, Humans, Aged, Retrospective Studies, oncologic outcomes, Rectal Neoplasms, business.industry, General surgery, TOTAL MESORECTAL EXCISION, medicine.disease, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Radiation therapy, Cross-Sectional Studies, Circumferential resection margin, Neoplasm Recurrence, Local, business
Abstract

Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark.Method In this collaborative research project, the dataset of the Dutch Surgical Colorectal Audit was extended with additional treatment and long-term outcome data. All registered patients who underwent resection for rectal cancer in 2011 were eligible. Baseline characteristics and outcome were evaluated against the results of the Dutch TME trial and the COLOR II trial from which the original datasets were obtained.Results A total of 71 hospitals participated, and data were completed for 2102 out of the potential 2633 patients (79.8%). Median follow-up was 41 (interquartile range 25-47) months. Overall circumferential resection margin (CRM) involvement was 9.3% in the Snapshot cohort and 18.5% in the Dutch TME trial. CRM positivity after laparoscopic resection was 7.8% in the Snapshot and 9.5% in the COLOR II trial. Three-year overall local recurrence rate in the Snapshot was 5.9%, with a disease-free survival of 67.1% and overall survival of 79.5%. Benchmarking with the randomized controlled trials revealed an overall favourable long-term outcome of the Snapshot cohort.Conclusion This study showed that current rectal cancer care in a large unselected Dutch population is of high quality, with less positive CRM since the TME trial and oncologically safe implementation of minimally invasive surgery after the COLOR II trial.

Published
2017

13. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Author

Rooij, T. de, Hilst, J. van, Vogel, J.A., Santvoort, H.C. van, Boer, M.T. de, Boerma, D., Boezem, P.B. van den, Bonsing, B.A., Bosscha, K., Coene, P.P., Daams, F., Dam, R.M. van, Dijkgraaf, M.G., Eijck, C.H. van, Festen, S., Gerhards, M.F., Koerkamp, B.G., Hagendoorn, J., Harst, E. van der, Hingh, I.H. de, Dejong, C.H., Kazemier, G., Klaase, J., Kleine, R.H. de, Laarhoven, C.J. van, Lips, D.J., Luyer, M.D., Molenaar, I.Q., Nieuwenhuijs, V.B., Patijn, G.A., Roos, D., Scheepers, J.J., Schelling, G.P. van der, Steenvoorde, P., Swijnenburg, R.J., Wijsman, J.H., Abu Hilal, M., Busch, O.R., Besselink, M.G., Dutch Pancreatic Canc Grp, CCA - Cancer Treatment and quality of life, AGEM - Re-generation and cancer of the digestive system, Surgery, Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), RS: NUTRIM - R2 - Gut-liver homeostasis, CCA - Cancer Treatment and Quality of Life, Other departments, APH - Methodology, Clinical Research Unit, and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Time Factors, medicine.medical_treatment, Cost-Benefit Analysis, Health Status, INTERNATIONAL STUDY-GROUP, Distal pancreatectomy, Medicine (miscellaneous), Administration, Oral, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Study Protocol, Eating, 0302 clinical medicine, Superiority Trial, Randomized controlled trial, Quality of life, Clinical Protocols, Robotic Surgical Procedures, law, SURGERY ISGPS, Pharmacology (medical), 030212 general & internal medicine, Hospital Costs, Laparoscopy, Netherlands, Pain Measurement, Analgesics, Pain, Postoperative, lcsh:R5-920, medicine.diagnostic_test, MALIGNANT-DISEASE, Robot-assisted, 3. Good health, Treatment Outcome, Research Design, 030220 oncology & carcinogenesis, Pancreatectomy, lcsh:Medicine (General), Cohort study, medicine.medical_specialty, LONG-TERM, BENIGN, Pancreatic surgery, DUCTAL ADENOCARCINOMA, PANCREATOSPLENECTOMY, CLINICAL-TRIAL, 03 medical and health sciences, Laparoscopic, medicine, Journal Article, Humans, IDEAL FRAMEWORK, Minimally invasive, business.industry, Recovery of Function, Pancreatic cancer, Surgery, Clinical trial, DEFINITION, Quality of Life, Observational study, business, Energy Intake
Abstract

Background Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. Methods LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. Discussion The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Trial registration Dutch Trial Register, NTR5188. Registered on 9 April 2015 Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1892-9) contains supplementary material, which is available to authorized users.

Published
2017

14. Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer

Author

Stijns, R.C.H., Graaf, E.J.R. de, Punt, C.J.A., Nagtegaal, I.D., Nuyttens, J.J.M.E., Meerten, E. van, Tanis, P.J., Hingh, I.H.J.T. de, Schelling, G.P. van der, Acherman, Y., Leijtens, J.W.A., Bremers, A.J.A., Beets, G.L., Hoff, C., Verhoef, C., Marijnen, C.A.M., Wilt, J.H.W. de, Bokkerink, G.M.J., Cats, A., Doornebosch, P.G., Dwarkasing, R.S., Rutten, H., Tije, A.J. ten, Tromp, M.S., Schoon, E., Verseveld, M., Buijsen, J., CARTS Study Grp, Radiotherapy, Medical Oncology, Surgery, Radiology & Nuclear Medicine, Oncology, CCA - Cancer Treatment and Quality of Life, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Male, Transanal Endoscopic Microsurgery, Colorectal cancer, medicine.medical_treatment, MULTICENTER, 030230 surgery, COLORECTAL-CANCER, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Quality of life, QUALITY-OF-LIFE, Interquartile range, LOCAL EXCISION, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Neoadjuvant therapy, Netherlands, ANTERIOR RESECTION SYNDROME, Aged, 80 and over, Middle Aged, OPEN-LABEL, Combined Modality Therapy, Total mesorectal excision, Treatment Outcome, Urological cancers Radboud Institute for Health Sciences [Radboudumc 15], 030220 oncology & carcinogenesis, Female, CLINICAL-TRIALS, Adult, medicine.medical_specialty, Disease-Free Survival, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, NEOADJUVANT CHEMORADIATION, medicine, Humans, Radical surgery, Aged, Rectal Neoplasms, business.industry, TOTAL MESORECTAL EXCISION, Chemoradiotherapy, Adjuvant, Microsurgery, medicine.disease, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Feasibility Studies, Neoplasm Recurrence, Local, business, Organ Sparing Treatments, POSTOPERATIVE CHEMORADIOTHERAPY, Chemoradiotherapy
Abstract

IMPORTANCE Treatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature.OBJECTIVE To explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3NOMO rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM).DESIGN, SETTING, AND PARTICIPANTS In this multicenter phase II feasibility study, patients with cT1-3NOMO rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017.MAIN OUTCOMES AND MEASURES The primary study outcome of the studywas the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL.RESULTS Of the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P =.001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation.CONCLUSIONS AND RELEVANCE In early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.

Published
2019

15. Nationwide prospective audit of pancreatic surgery: design, accuracy, and outcomes of the Dutch Pancreatic Cancer Audit

Author

Rijssen, L.B. van, Koerkamp, B.G., Zwart, M.J., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Harst, E. van der, Hingh, I.H. de, Jong, K.P. de, Kazemier, G., Klaase, J., Laarhoven, C.J.H.M. van, Molenaar, I.Q., Patijn, G.A., Rupert, C.G., Santvoort, H.C. van, Scheepers, J.J., Schelling, G.P. van der, Busch, O.R., Besselink, M.G., Rijssen, L.B. van, Koerkamp, B.G., Zwart, M.J., Bonsing, B.A., Bosscha, K., Dam, R.M. van, Eijck, C.H. van, Gerhards, M.F., Harst, E. van der, Hingh, I.H. de, Jong, K.P. de, Kazemier, G., Klaase, J., Laarhoven, C.J.H.M. van, Molenaar, I.Q., Patijn, G.A., Rupert, C.G., Santvoort, H.C. van, Scheepers, J.J., Schelling, G.P. van der, Busch, O.R., and Besselink, M.G.

Abstract

Item does not contain fulltext, BACKGROUND: Auditing is an important tool to identify practice variation and 'best practices'. The Dutch Pancreatic Cancer Audit is mandatory in all 18 Dutch centers for pancreatic surgery. METHODS: Performance indicators and case-mix factors were identified by a PubMed search for randomized controlled trials (RCT's) and large series in pancreatic surgery. In addition, data dictionaries of two national audits, three institutional databases, and the Dutch national cancer registry were evaluated. Morbidity, mortality, and length of stay were analyzed of all pancreatic resections registered during the first two audit years. Case ascertainment was cross-checked with the Dutch healthcare inspectorate and key-variables validated in all centers. RESULTS: Sixteen RCT's and three large series were found. Sixteen indicators and 20 case-mix factors were included in the audit. During 2014-2015, 1785 pancreatic resections were registered including 1345 pancreatoduodenectomies. Overall in-hospital mortality was 3.6%. Following pancreatoduodenectomy, mortality was 4.1%, Clavien-Dindo grade >/= III morbidity was 29.9%, median (IQR) length of stay 12 (9-18) days, and readmission rate 16.0%. In total 97.2% of >40,000 variables validated were consistent with the medical charts. CONCLUSIONS: The Dutch Pancreatic Cancer Audit, with high quality data, reports good outcomes of pancreatic surgery on a national level.

Published
2017

16. Impact of a Nationwide Training Program in Minimally Invasive Distal Pancreatectomy (LAELAPS)

Author

Rooij, T. de, Hilst, J. van, Boerma, D., Bonsing, B.A., Daams, F., Dam, R.M. van, Dijkgraaf, M.G., Eijck, C.H. van, Festen, S., Gerhards, M.F., Koerkamp, B.G., Harst, E. van der, Hingh, I.H. de, Kazemier, G., Klaase, J., Kleine, R.H. de, Laarhoven, C.J.H.M. van, Lips, D.J., Luyer, M.D., Molenaar, I.Q., Patijn, G.A., Roos, D., Scheepers, J.J., Schelling, G.P. van der, Steenvoorde, P., Vriens, M.R., Wijsman, J.H., Gouma, D.J., Busch, O.R., Hilal, M.A., Besselink, M.G., Rooij, T. de, Hilst, J. van, Boerma, D., Bonsing, B.A., Daams, F., Dam, R.M. van, Dijkgraaf, M.G., Eijck, C.H. van, Festen, S., Gerhards, M.F., Koerkamp, B.G., Harst, E. van der, Hingh, I.H. de, Kazemier, G., Klaase, J., Kleine, R.H. de, Laarhoven, C.J.H.M. van, Lips, D.J., Luyer, M.D., Molenaar, I.Q., Patijn, G.A., Roos, D., Scheepers, J.J., Schelling, G.P. van der, Steenvoorde, P., Vriens, M.R., Wijsman, J.H., Gouma, D.J., Busch, O.R., Hilal, M.A., and Besselink, M.G.

Abstract

Item does not contain fulltext, OBJECTIVE: To study the feasibility and impact of a nationwide training program in minimally invasive distal pancreatectomy (MIDP). SUMMARY OF BACKGROUND DATA: Superior outcomes of MIDP compared with open distal pancreatectomy have been reported. In the Netherlands (2005 to 2013) only 10% of distal pancreatectomies were in a minimally invasive fashion and 85% of surgeons welcomed MIDP training. The feasibility and impact of a nationwide training program is unknown. METHODS: From 2014 to 2015, 32 pancreatic surgeons from 17 centers participated in a nationwide training program in MIDP, including detailed technique description, video training, and proctoring on-site. Outcomes of MIDP before training (2005-2013) were compared with outcomes after training (2014-2015). RESULTS: In total, 201 patients were included; 71 underwent MIDP in 9 years before training versus 130 in 22 months after training (7-fold increase, P < 0.001). The conversion rate (38% [n = 27] vs 8% [n = 11], P < 0.001) and blood loss were lower after training and more pancreatic adenocarcinomas were resected (7 [10%] vs 28 [22%], P = 0.03), with comparable R0-resection rates (4/7 [57%] vs 19/28 [68%], P = 0.67). Clavien-Dindo score >/=III complications (15 [21%] vs 19 [15%], P = 0.24) and pancreatic fistulas (20 [28%] vs 41 [32%], P = 0.62) were not significantly different. Length of hospital stay was shorter after training (9 [7-12] vs 7 [5-8] days, P < 0.001). Thirty-day mortality was 3% vs 0% (P = 0.12). CONCLUSION: A nationwide MIDP training program was feasible and followed by a steep increase in the use of MIDP, also in patients with pancreatic cancer, and decreased conversion rates. Future studies should determine whether such a training program is applicable in other settings.

Published
2016

17. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

Author

Bakker, O.J., Santvoort, H.C. van, Brunschot, S. van, Ali, U.A., Besselink, M.G., Boermeester, M.A., Bollen, T.L., Bosscha, K., Brink, M.A., Dejong, C.H., Geenen, E.J. van, Goor, H. van, Heisterkamp, J., Houdijk, A.P., Jansen, J.M., Karsten, T.M., Manusama, E.R., Nieuwenhuijs, V.B., Ramshorst, B. van, Schaapherder, A.F., Schelling, G.P. van der, Spanier, M.B.M., Tan, A., Vecht, J., Weusten, B.L., Witteman, B.J., Akkermans, L.M., Gooszen, H.G., Dutch Pancreatitis Study Grp, Surgery, RS: NUTRIM - R2 - Gut-liver homeostasis, RS: MHeNs School for Mental Health and Neuroscience, Graduate School, AII - Amsterdam institute for Infection and Immunity, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Other departments, Gastroenterology and hepatology, CCA - Innovative therapy, and Faculteit der Geneeskunde

Subjects
medicine.medical_specialty, Time Factors, OVERGROWTH, Medicine (miscellaneous), Enteral administration, Severity of Illness Index, PROPHYLAXIS, law.invention, DOUBLE-BLIND, Study Protocol, ACUTE NECROTIZING PANCREATITIS, Enteral Nutrition, Randomized controlled trial, law, BACTERIAL TRANSLOCATION, Internal medicine, Multicenter trial, Severity of illness, medicine, Clinical endpoint, Humans, Pharmacology (medical), SMALL-BOWEL MOTILITY, METAANALYSIS, APACHE, Netherlands, lcsh:R5-920, business.industry, MORTALITY, Bacterial Infections, medicine.disease, Surgery, Parenteral nutrition, Treatment Outcome, Pancreatitis, Evaluation of complex medical interventions [NCEBP 2], Research Design, Acute Disease, Acute pancreatitis, ARTIFICIAL NUTRITION, business, lcsh:Medicine (General), ORGAN FAILURE
Abstract

Background In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. Methods/Design The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission. During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective. Discussion The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis. Trial Registration ISRCTN: ISRCTN18170985

Published
2011

18. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome

Author

Santvoort, H.C. van, Bakker, O.J., Bollen, T.L., Besselink, M.G., Ali, U.A., Schrijver, A.M., Boermeester, M.A., Goor, H. van, Dejong, C.H., Eijck, C.H. van, Ramshorst, B. van, Schaapherder, A.F., Harst, E. van der, Hofker, S., Nieuwenhuijs, V.B., Brink, M.A., Kruyt, P.M., Manusama, E.R., Schelling, G.P. van der, Karsten, T., Hesselink, E.J., Laarhoven, C.J. van, Rosman, C., Bosscha, K., Wit, R.J. de, Houdijk, A.P., Cuesta, M.A., Wahab, P.J., Gooszen, H.G., Dutch Pancreatitis Study Grp, Surgery, CCA - Innovative therapy, RS: NUTRIM - R2 - Gut-liver homeostasis, Graduate School, AII - Amsterdam institute for Infection and Immunity, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Radiology and Nuclear Medicine, Other departments, CCA -Cancer Center Amsterdam, and Gastroenterology and Hepatology

Subjects
Male, Time Factors, Abdominal compartment syndrome, medicine.medical_treatment, Single Center, GUIDELINES, Severity of Illness Index, Interquartile range, Risk Factors, Laparotomy, Odds Ratio, Prospective Studies, Prospective cohort study, Netherlands, Randomized Controlled Trials as Topic, APACHE II, Nutritional Support, Pancreatitis, Acute Necrotizing, NECROSIS, Gastroenterology, Middle Aged, NECROSECTOMY, Clinical Trial, Anti-Bacterial Agents, Treatment Outcome, SURGICAL-MANAGEMENT, Drainage, Female, ABDOMINAL COMPARTMENT SYNDROME, ORGAN FAILURE, Adult, medicine.medical_specialty, Multiple Organ Failure, Risk Assessment, Catheterization, RETROPERITONEAL APPROACH, Pancreatectomy, Severity of illness, medicine, Humans, Molecular gastro-enterology and hepatology [IGMD 2], Pancreas, Aged, Inflammation, Chi-Square Distribution, Hepatology, business.industry, Patient Selection, MORTALITY, Endoscopy, medicine.disease, Surgery, Treatment, Logistic Models, Debridement, Evaluation of complex medical interventions [NCEBP 2], Linear Models, Pancreatitis, EXPERIENCE, Emergencies, business, Tomography, X-Ray Computed, SINGLE-CENTER
Abstract

BACKGROUND & AIMS: Treatment of patients with necrotizing pancreatitis has become more conservative and less invasive, but there are few data from prospective studies to support the efficacy of this change. We performed a prospective multicenter study of treatment outcomes among patients with necrotizing pancreatitis. METHODS: We collected data from 639 consecutive patients with necrotizing pancreatitis, from 2004 to 2008, treated at 21 Dutch hospitals. Data were analyzed for disease severity, interventions (radiologic, endoscopic, surgical), and outcome. RESULTS: Overall mortality was 15% (n = 93). Organ failure occurred in 240 patients (38%), with 35% mortality. Treatment was conservative in 397 patients (62%), with 7% mortality. An intervention was performed in 242 patients (38%), with 27% mortality; this included early emergency laparotomy in 32 patients (5%), with 78% mortality. Patients with longer times between admission and intervention had lower mortality: 0 to 14 days, 56%; 14 to 29 days, 26%; and >29 days, 15% (P

Published
2011

19. A Step-up Approach or Open Necrosectomy for Necrotizing Pancreatitis

Author

Santvoort, H.C. van, Besselink, M.G., Bakker, O.J., Hofker, H.S., Boermeester, M.A., Dejong, C.H., Goor, H. van, Schaapherder, A.F., Eijck, C.H. van, Bollen, T.L., Ramshorst, B. van, Nieuwenhuijs, V.B., Timmer, R., Lameris, J.S., Kruyt, P.M., Manusama, E.R., Harst, E. van der, Schelling, G.P. van der, Karsten, T., Hesselink, E.J., Laarhoven, C.J. van, Rosman, C., Bosscha, K., Wit, R.J. de, Houdijk, A.P., Leeuwen, M.S. van, Buskens, E., Gooszen, H.G., and Dutch Pancreatitis Study Grp

Subjects
endoscopic necrosectomy surgical intervention necrosis management debridement guidelines drainage patient lavage
Abstract

BACKGROUND Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach. METHODS In this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death. RESULTS The primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P = 0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P = 0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P = 0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P = 0.03) and new-onset diabetes (16% vs. 38%, P = 0.02). CONCLUSIONS A minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)

Published
2010

20. Early versus on-demand nasoenteric tube feeding in acute pancreatitis

Author

Bakker, O.J., Brunschot, S. van, Santvoort, H.C. van, Besselink, M.G., Bollen, T.L., Boermeester, M.A., Dejong, C.H., Goor, H. van, Bosscha, K., Ahmed Ali, U., Bouwense, S., Grevenstein, W.M. van, Heisterkamp, J., Houdijk, A.P., Jansen, J.M., Karsten, T.M., Manusama, E.R., Nieuwenhuijs, V.B., Schaapherder, A.F., Schelling, G.P. van der, Schwartz, M.P., Spanier, B.W., Tan, A., Vecht, J., Weusten, B.L., Witteman, B.J., Akkermans, L.M., Bruno, M.J., Dijkgraaf, M.G., Ramshorst, B. van, Gooszen, H.G., Study, G., Bakker, O.J., Brunschot, S. van, Santvoort, H.C. van, Besselink, M.G., Bollen, T.L., Boermeester, M.A., Dejong, C.H., Goor, H. van, Bosscha, K., Ahmed Ali, U., Bouwense, S., Grevenstein, W.M. van, Heisterkamp, J., Houdijk, A.P., Jansen, J.M., Karsten, T.M., Manusama, E.R., Nieuwenhuijs, V.B., Schaapherder, A.F., Schelling, G.P. van der, Schwartz, M.P., Spanier, B.W., Tan, A., Vecht, J., Weusten, B.L., Witteman, B.J., Akkermans, L.M., Bruno, M.J., Dijkgraaf, M.G., Ramshorst, B. van, Gooszen, H.G., and Study, G.

Abstract

Contains fulltext : 148790.pdf (publisher's version ) (Open Access), BACKGROUND: Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections, but evidence to support this strategy is limited. We conducted a multicenter, randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis. METHODS: We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher (on a scale of 0 to 71, with higher scores indicating more severe disease), an Imrie or modified Glasgow score of 3 or higher (on a scale of 0 to 8, with higher scores indicating more severe disease), or a serum C-reactive protein level of more than 150 mg per liter. Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization (early group) or to an oral diet initiated 72 hours after presentation (on-demand group), with tube feeding provided if the oral diet was not tolerated. The primary end point was a composite of major infection (infected pancreatic necrosis, bacteremia, or pneumonia) or death during 6 months of follow-up. RESULTS: A total of 208 patients were enrolled at 19 Dutch hospitals. The primary end point occurred in 30 of 101 patients (30%) in the early group and in 28 of 104 (27%) in the on-demand group (risk ratio, 1.07; 95% confidence interval, 0.79 to 1.44; P=0.76). There were no significant differences between the early group and the on-demand group in the rate of major infection (25% and 26%, respectively; P=0.87) or death (11% and 7%, respectively; P=0.33). In the on-demand group, 72 patients (69%) tolerated an oral diet and did not require tube feeding. CONCLUSIONS: This trial did not show the superiority of early nasoenteric tube feeding, as compared with an oral diet after 72 hours, in reducing the rate of infection or death

Published
2014

21. The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery.

Author

Bokkerink, G.M., Graaf, E.J. de, Punt, C.J., Nagtegaal, I.D., Rütten, H., Nuyttens, J.J., Meerten, E. van, Doornebosch, P.G., Tanis, P.J., Derksen, E.J., Dwarkasing, R.S., Marijnen, C.A., Cats, A., Tollenaar, R.A.E.M., Hingh, I.H.J.T. de, Rutten, H.J., Schelling, G.P. van der, Tije, A. ten, Leijtens, J.W.A., Lammering, G., Beets, G.L., Aufenacker, T.J., Pronk, A., Manusama, E.R., Hoff, C., Bremers, A.J.A., Verhoef, C.G., Wilt, J.H. de, Bokkerink, G.M., Graaf, E.J. de, Punt, C.J., Nagtegaal, I.D., Rütten, H., Nuyttens, J.J., Meerten, E. van, Doornebosch, P.G., Tanis, P.J., Derksen, E.J., Dwarkasing, R.S., Marijnen, C.A., Cats, A., Tollenaar, R.A.E.M., Hingh, I.H.J.T. de, Rutten, H.J., Schelling, G.P. van der, Tije, A. ten, Leijtens, J.W.A., Lammering, G., Beets, G.L., Aufenacker, T.J., Pronk, A., Manusama, E.R., Hoff, C., Bremers, A.J.A., Verhoef, C.G., and Wilt, J.H. de

Abstract

Contains fulltext : 96401.pdf (publisher's version ) (Open Access)

Published
2011

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