15 results on '"Andel PCM"'
Search Results
2. Routine Imaging or Symptomatic Follow-Up After Resection of Pancreatic Adenocarcinoma.
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Andel PCM, van Goor IWJM, Augustinus S, Berrevoet F, Besselink MG, Bhojwani R, Boggi U, Bouwense SAW, Cirkel GA, van Dam JL, Djanani A, Dorcaratto D, Dreyer S, den Dulk M, Frigerio I, Ghorbani P, Goetz MR, Groot Koerkamp B, Gryspeerdt F, Hidalgo Salinas C, Intven M, Izbicki JR, Jorba Martin R, Kauffmann EF, Klug R, Liem MSL, Luyer MDP, Maglione M, Martin-Perez E, Meerdink M, de Meijer VE, Nieuwenhuijs VB, Nikov A, Nunes V, Pando E, Radenkovic D, Roeyen G, Sanchez-Bueno F, Serrablo A, Sparrelid E, Tepetes K, Thakkar RG, Tzimas GN, Verdonk RC, Ten Winkel M, Zerbi A, Groot VP, Molenaar IQ, Daamen LA, and van Santvoort HC
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- Humans, Male, Female, Aged, Middle Aged, Prospective Studies, Cross-Sectional Studies, Survival Rate, Follow-Up Studies, Pancreatic Neoplasms surgery, Pancreatic Neoplasms mortality, Neoplasm Recurrence, Local, Pancreatectomy, Carcinoma, Pancreatic Ductal surgery, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal diagnostic imaging, Carcinoma, Pancreatic Ductal pathology
- Abstract
Importance: International guidelines lack consistency in their recommendations regarding routine imaging in the follow-up after pancreatic resection for pancreatic ductal adenocarcinoma (PDAC). Consequently, follow-up strategies differ between centers worldwide., Objective: To compare clinical outcomes, including recurrence-focused treatment and survival, in patients with PDAC recurrence who received symptomatic follow-up or routine imaging after pancreatic resection in international centers affiliated with the European-African Hepato-Pancreato-Biliary Association (E-AHPBA)., Design, Setting, and Participants: This was a prospective, international, cross-sectional study. Patients from a total of 33 E-AHPBA centers from 13 countries were included between 2020 and 2021. According to the predefined study protocol, patients who underwent PDAC resection and were diagnosed with disease recurrence were prospectively included. Patients were stratified according to postoperative follow-up strategy: symptomatic follow-up (ie, without routine imaging) or routine imaging., Exposures: Symptomatic follow-up or routine imaging in patients who underwent PDAC resection., Main Outcomes and Measures: Overall survival (OS) was estimated with Kaplan-Meier curves and compared using the log-rank test. To adjust for potential confounders, multivariable logistic regression was used to evaluate the association between follow-up strategy and recurrence-focused treatment. Multivariable Cox proportional hazard analysis was used to study the independent association between follow-up strategy and OS., Results: Overall, 333 patients (mean [SD] age, 65 [11] years; 184 male [55%]) with PDAC recurrence were included. Median (IQR) follow-up at time of analysis 2 years after inclusion of the last patient was 40 (30-58) months. Of the total cohort, 98 patients (29%) received symptomatic follow-up, and 235 patients (71%) received routine imaging. OS was 23 months (95% CI, 19-29 months) vs 28 months (95% CI, 24-30 months) in the groups who received symptomatic follow-up vs routine imaging, respectively (P = .01). Routine imaging was associated with receiving recurrence-focused treatment (adjusted odds ratio, 2.57; 95% CI, 1.22-5.41; P = .01) and prolonged OS (adjusted hazard ratio, 0.75; 95% CI, 0.56-.99; P = .04)., Conclusion and Relevance: In this international, prospective, cross-sectional study, routine follow-up imaging after pancreatic resection for PDAC was independently associated with receiving recurrence-focused treatment and prolonged OS.
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- 2025
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3. Defining and Predicting Early Recurrence for Optimal Treatment Strategies for Intraductal Papillary Mucinous Neoplasm-Derived Pancreatic Cancer: An International Multicenter Study.
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Habib JR, Javed AA, Rompen IF, Hidalgo Salinas C, Sorrentino A, Campbell BA, Andel PCM, Groot VP, Lafaro KJ, Sacks GD, Billeter AT, Molenaar IQ, Müller-Stich BP, Besselink MG, He J, Wolfgang CL, and Daamen LA
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Background: Early recurrence in intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) is poorly defined. Predictors are lacking and needed for patient counseling, risk stratification, and postoperative management. This study aimed to define and predict early recurrence for patients in resected IPMN-derived PDAC and guide management., Methods: A lowest p value for survival after recurrence (SAR) was used to define early recurrence in resected IPMN-derived PDAC from five international centers. Overall survival (OS) and SAR were compared using log-rank tests. A multivariable logistic regression identified odds ratios (ORs) with 95 % confidence intervals (CIs) for early recurrence. Rounded ORs were used to stratify patients into low-, intermediate-, and high-risk groups using upper and lower quartile score distributions. Adjuvant chemotherapy was assessed by Cox regression and log-rank tests for OS in risk groups., Results: Recurrence developed in 160 (42 %) of 381 patients. Early recurrence was defined at 10.5 months and observed in 61 patients (38 % of recurrences). The median SAR for the patients with early recurrence was 8.3 months (95 % CI, 3.1-16.1 months) compared with 12.9 months (95 % CI, 5.2-27.5 months) for the patients with late recurrence. The independent predictors of early recurrence were CA19-9 (OR, 3.80; 95 % CI, 1.54-9.41) and N2 disease (OR, 7.29; 95 % CI, 3.22-16.49). The early recurrence rates in the low-, intermediate-, and high-risk groups were respectively 1 %, 14 %, and 32 %. Adjuvant chemotherapy was associated with improved OS only for the high-risk patients (hazard ratio, 0.50; 95 % CI, 0.32-0.79)., Conclusion: In IPMN-derived PDAC, the optimal cutoff for early recurrence is 10.5 months. Both CA19-9 and N stage predict early recurrence. Adjuvant chemotherapy is associated with survival benefit only for high-risk patients., Competing Interests: Disclosure: There are no conflicts of interest., (© 2024. Society of Surgical Oncology.)
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- 2024
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4. Competency, Proficiency, and Mastery: Learning Curves for Robotic Distal Pancreatectomy at 16 International Expert Centers.
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Müller PC, Kuemmerli C, Billeter AT, Shen B, Jin J, Nickel F, Guidetti C, Kauffmann E, Purchla J, Tschuor C, Krohn PS, Burgdorf SK, Jonas JP, Bussmann FJ, Saint-Marc O, Iben-Khayat A, Andel PCM, Molenaar IQ, Wellner U, Keck T, Moeckli B, Toso C, Di Benedetto F, Valle V, Giulianotti P, Roulin D, Martinie JB, Rama M, Lavu H, Yeo C, Mavani PT, Shah MM, Kooby DA, He J, Boggi U, Hackert T, Borel-Rinkes IHM, Müller BP, and Clavien PA
- Abstract
Objective: The aim of this study was to evaluate the different phases of the learning curve for robotic distal pancreatectomy (RDP) in international expert centers., Summary Background Data: RDP is an emerging minimally invasive approach; however, only limited, mostly single center data are available on its safe implementation, including the learning curve., Methods: Consecutive patients undergoing elective RDP from 16 expert centers across three continents were included to assess the learning curve. Based on the first 100 RDPs at each center, three cutoffs were used to define the learning curve: operative time for competency, major complications (Clavien-Dindo grade ≥III) for proficiency, and textbook outcome for mastery. Clinical outcomes before and after the cutoffs were compared., Results: The learning curve analysis was conducted on 1109 of 2403 RDPs. Competency, proficiency, and mastery, respectively, were reached after 46, 63, and 73 RDP procedures. After competency, operative time decreased from 245 to 235 minutes (P=0.002). Attaining proficiency was reflected by a reduction in the rate of major complications from 20% to 15% (P=0.012), and mastery was associated with a higher proportion of patients with textbook outcome (71% vs. 63%; P=0.028). The postoperative pancreatic fistula rate remained stable along the learning curve, ranging between 18.5% and 21.5%. Previous laparoscopic experience accelerated the learning process by virtue of reduced operative time and an earlier decrease in major complications., Conclusion: Competency, proficiency, and mastery for RDP were reached after 46, 63, and 73 procedures, respectively, at international expert centers. The findings highlight that the learning curves for intraoperative parameters are completed earlier; however, extensive experience is needed to master RDP., Competing Interests: Conflict of interest: The authors declare that they have no conflict of interest. Conflict of interest: The authors declare that no conflict of interest exists. No grants and financial support were received for this study., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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5. An international multi-institutional validation of T1 sub-staging of intraductal papillary mucinous neoplasm-derived pancreatic cancer.
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Habib JR, Rompen IF, Campbell BA, Andel PCM, Kinny-Köster B, Damaseviciute R, Brock Hewitt D, Sacks GD, Javed AA, Besselink MG, van Santvoort HC, Daamen LA, Loos M, He J, Quintus Molenaar I, Büchler MW, and Wolfgang CL
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- Humans, Female, Male, Aged, Middle Aged, Pancreatic Intraductal Neoplasms pathology, Pancreatic Intraductal Neoplasms mortality, Adenocarcinoma, Mucinous pathology, Adenocarcinoma, Mucinous mortality, Adenocarcinoma, Mucinous surgery, Retrospective Studies, Kaplan-Meier Estimate, Prognosis, Pancreatectomy, Pancreatic Neoplasms pathology, Pancreatic Neoplasms mortality, Neoplasm Staging, Carcinoma, Pancreatic Ductal pathology, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal surgery
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Background: Intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) is resected at smaller sizes compared with its biologically distinct counterpart, pancreatic intraepithelial neoplasia (PanIN)-derived PDAC. Thus, experts proposed T1 sub-staging for IPMN-derived PDAC. However, this has never been validated., Methods: Consecutive upfront surgery patients with IPMN-derived PDAC from 5 international high-volume centers were classified by the proposed T1 sub-staging classification (T1a ≤0.5, T1b >0.5 and ≤1.0, and T1c >1.0 and ≤2.0 cm) using the invasive component size. Kaplan-Meier and log-rank tests were used to compare overall survival (OS). A multivariable Cox regression was used to determine hazard ratios (HRs) with confidence intervals (95% CIs)., Results: Among 747 patients, 69 (9.2%), 50 (6.7%), 99 (13.0%), and 531 patients (71.1%), comprised the T1a, T1b, T1c, and T2-4 subgroups, respectively. Increasing T-stage was associated with elevated CA19-9, poorer grade, nodal positivity, R1 margin, and tubular subtype. Median OS for T1a, T1b, T1c, and T2-4 were 159.0 (95% CI = 126.0 to NR), 128.8 (98.3 to NR), 77.6 (48.3 to 108.2), and 31.4 (27.5 to 37.7) months, respectively (P < .001). OS decreased with increasing T-stage for all pairwise comparisons (all P < .05). After risk adjustment, older than age 65, elevated CA19-9, T1b [HR = 2.55 (1.22 to 5.32)], T1c [HR = 3.04 (1.60 to 5.76)], and T2-4 [HR = 3.41 (1.89 to 6.17)] compared with T1a, nodal positivity, R1 margin, and no adjuvant chemotherapy were associated with worse OS. Disease recurrence was more common in T2-4 tumors (56.4%) compared with T1a (18.2%), T1b (23.9%), and T1c (36.1%, P < .001)., Conclusion: T1 sub-staging of IPMN-derived PDAC is valid and has significant prognostic value. Advancing T1 sub-stage is associated with worse histopathology, survival, and recurrence. T1 sub-staging is recommended for future guidelines., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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6. Prediction of Isolated Local Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Nationwide Study.
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van Goor IWJM, Andel PCM, Buijs FS, Besselink MG, Bonsing BA, Bosscha K, Busch OR, Cirkel GA, van Dam RM, Festen S, Koerkamp BG, van der Harst E, de Hingh IHJT, Kazemier G, Liem MSL, Meijer G, de Meijer VE, Nieuwenhuijs VB, Roos D, Schreinemakers JMJ, Stommel MWJ, Wit F, Verdonk RC, van Santvoort HC, Molenaar IQ, Intven MPW, and Daamen LA
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- Humans, Female, Male, Aged, Middle Aged, Prognosis, Follow-Up Studies, Netherlands epidemiology, Survival Rate, Risk Factors, Neoplasm Recurrence, Local pathology, Carcinoma, Pancreatic Ductal surgery, Carcinoma, Pancreatic Ductal pathology, Pancreatic Neoplasms surgery, Pancreatic Neoplasms pathology, Pancreatectomy
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Background: Distinguishing postoperative fibrosis from isolated local recurrence (ILR) after resection of pancreatic ductal adenocarcinoma (PDAC) is challenging. A prognostic model that helps to identify patients at risk of ILR can assist clinicians when evaluating patients' postoperative imaging. This nationwide study aimed to develop a clinically applicable prognostic model for ILR after PDAC resection., Patients and Methods: An observational cohort study was performed, including all patients who underwent PDAC resection in the Netherlands (2014-2019; NCT04605237). On the basis of recurrence location (ILR, systemic, or both), multivariable cause-specific Cox-proportional hazard analysis was conducted to identify predictors for ILR and presented as hazard ratios (HRs) with 95% confidence intervals (CIs). A predictive model was developed using Akaike's Information Criterion, and bootstrapped discrimination and calibration indices were assessed., Results: Among 1194/1693 patients (71%) with recurrence, 252 patients (21%) developed ILR. Independent predictors for ILR were resectability status (borderline versus resectable, HR 1.42; 95% CI 1.03-1.96; P = 0.03, and locally advanced versus resectable, HR 1.11; 95% CI 0.68-1.82; P = 0.66), tumor location (head versus body/tail, HR 1.50; 95% CI 1.00-2.25; P = 0.05), vascular resection (HR 1.86; 95% CI 1.41-2.45; P < 0.001), perineural invasion (HR 1.47; 95% CI 1.01-2.13; P = 0.02), number of positive lymph nodes (HR 1.04; 95% CI 1.01-1.08; P = 0.02), and resection margin status (R1 < 1 mm versus R0 ≥ 1 mm, HR 1.64; 95% CI 1.25-2.14; P < 0.001). Moderate performance (concordance index 0.66) with adequate calibration (slope 0.99) was achieved., Conclusions: This nationwide study identified factors predictive of ILR after PDAC resection. Our prognostic model, available through www.pancreascalculator.com , can be utilized to identify patients with a higher a priori risk of developing ILR, providing important information in patient evaluation and prognostication., (© 2024. The Author(s).)
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- 2024
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7. Outcomes in intraductal papillary mucinous neoplasm-derived pancreatic cancer differ from PanIN-derived pancreatic cancer.
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Habib JR, Rompen IF, Javed AA, Grewal M, Kinny-Köster B, Andel PCM, Hewitt DB, Sacks GD, Besselink MG, van Santvoort HC, Daamen LA, Loos M, He J, Büchler MW, Wolfgang CL, and Molenaar IQ
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- Humans, Male, Female, Aged, Middle Aged, Retrospective Studies, Pancreatic Intraductal Neoplasms pathology, Pancreatic Intraductal Neoplasms mortality, Neoplasm Staging, Survival Rate, Carcinoma in Situ pathology, Carcinoma in Situ mortality, Pancreatic Neoplasms mortality, Pancreatic Neoplasms pathology, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal pathology, Adenocarcinoma, Mucinous pathology, Adenocarcinoma, Mucinous mortality
- Abstract
Background and Aim: Intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) management is generally extrapolated from pancreatic intraepithelial neoplasia (PanIN)-derived PDAC guidelines. However, these are biologically divergent, and heterogeneity further exists between tubular and colloid subtypes., Methods: Consecutive upfront surgery patients with PanIN-derived and IPMN-derived PDAC were retrospectively identified from international centers (2000-2019). One-to-one propensity score matching for clinicopathologic factors generated three cohorts: IPMN-derived versus PanIN-derived PDAC, tubular IPMN-derived versus PanIN-derived PDAC, and tubular versus colloid IPMN-derived PDAC. Overall survival (OS) was compared using Kaplan-Meier and log-rank tests. Multivariable Cox regression determined corresponding hazard ratios (HR) and 95% confidence intervals (95% CI)., Results: The median OS (mOS) in 2350 PanIN-derived and 700 IPMN-derived PDAC patients was 23.0 and 43.1 months (P < 0.001), respectively. PanIN-derived PDAC had worse T-stage, CA19-9, grade, and nodal status. Tubular subtype had worse T-stage, CA19-9, grade, nodal status, and R1 margins, with a mOS of 33.7 versus 94.1 months (P < 0.001) in colloid. Matched (n = 495), PanIN-derived and IPMN-derived PDAC had mOSs of 30.6 and 42.8 months (P < 0.001), respectively. In matched (n = 341) PanIN-derived and tubular IPMN-derived PDAC, mOS remained poorer (27.7 vs 37.4, P < 0.001). Matched tubular and colloid cancers (n = 112) had similar OS (P = 0.55). On multivariable Cox regression, PanIN-derived PDAC was associated with worse OS than IPMN-derived (HR: 1.66, 95% CI: 1.44-1.90) and tubular IPMN-derived (HR: 1.53, 95% CI: 1.32-1.77) PDAC. Colloid and tubular subtype was not associated with OS (P = 0.16)., Conclusions: PanIN-derived PDAC has worse survival than IPMN-derived PDAC supporting distinct outcomes. Although more indolent, colloid IPMN-derived PDAC has similar survival to tubular after risk adjustment., (© 2024 The Author(s). Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)
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- 2024
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8. Total versus Partial Pancreatectomy in Patients with Pancreatic Cancer Arising from Multifocal or Diffuse Intraductal Papillary Mucinous Neoplasia - A Multicenter Observational Study.
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Rompen IF, Habib JR, Kinny-Köster B, Campbell BA, Stoop TF, Kümmerli C, Andel PCM, Leseman CA, Lesch C, Daamen LA, Javed AA, Lafaro KJ, Nienhüser H, Billeter AT, Molenaar IQ, Müller-Stich BP, Besselink MG, He J, Loos M, Büchler MW, and Wolfgang CL
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Aim: To investigate the impact of total pancreatectomy (TP) on oncological outcomes for patients at high-risk of local recurrence or secondary progression in the remnant gland after partial pancreatectomy (PP) for IPMN-associated cancer., Summary Background Data: Major risk factors for invasive progression in the remnant gland include multifocality, diffuse main duct dilation, and the presence of invasive cancer. In these high-risk patients, a TP may be oncologically beneficial. However, current guidelines discourage TP, especially in elderly patients., Methods: This international multicenter study compares TP versus PP in patients with adenocarcinoma arising from multifocal or diffuse IPMN (2002-2022). Log-rank test and multivariable Cox-analysis with interaction analysis was performed to assess overall survival (OS), disease-free survival (DFS), and local-DFS., Results: Of 359 included patients, 162 (45%) were treated with TP, whereas 197 (55%) underwent PP. Despite TP and PP having similar R0-rates (59% vs. 58%, P=0.866), patients undergoing a TP had significantly longer local-DFS compared to PP (P=0.039). However, no difference in OS was observed between the two surgical approaches (P=0.487). In a multivariable analysis, young age (optimal cut-off ≤63.6 yrs) was associated with an OS benefit derived from TP (HR:0.44, 95%CI:0.22-0.89), whereas no significant difference was observed in elderly patients (HR:1.24, 95%CI:0.92-1.67, Pinteraction=0.007)., Conclusion: Since overall, patients with diffuse or multifocal IPMN with an invasive component do not benefit from TP in terms of OS, the indication for TP may be individualized to young patients who have sufficient life expectancy to benefit from the prevention of secondary progression or local recurrence., Competing Interests: Conflicts of Interest: None declared. Disclosures: There are no conflicts of interest for any of the authors., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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9. Informing Decision-making for Transected Margin Reresection in Intraductal Papillary Mucinous Neoplasm-derived PDAC: An International Multicenter Study.
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Habib JR, Rompen IF, Kinny-Köster B, Campbell BA, Andel PCM, Sacks GD, Billeter AT, van Santvoort HC, Daamen LA, Javed AA, Müller-Stich BP, Besselink MG, Büchler MW, He J, Wolfgang CL, Molenaar IQ, and Loos M
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Objective: To assess the prognostic impact of margin status in patients with resected intraductal papillary mucinous neoplasms (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) and to inform future intraoperative decision-making on handling differing degrees of dysplasia on frozen section., Summary Background Data: The ideal oncologic surgical outcome is a negative transection margin with normal pancreatic epithelium left behind. However, the prognostic significance of reresecting certain degrees of dysplasia or invasive cancer at the pancreatic neck margin during pancreatectomy for IPMN-derived PDAC is debatable., Methods: Consecutive patients with resected and histologically confirmed IPMN-derived PDAC (2002-2022) from six international high-volume centers were included. The prognostic relevance of a positive resection margin (R1) and degrees of dysplasia at the pancreatic neck margin were assessed by log-rank test and multivariable Cox-regression for overall survival (OS) and recurrence-free survival (RFS)., Results: Overall, 832 patients with IPMN-derived PDAC were included with 322 patients (39%) having an R1-resection on final pathology. Median OS (mOS) was significantly longer in patients with an R0 status compared to those with an R1 status (65.8 vs. 26.3 mo P<0.001). Patients without dysplasia at the pancreatic neck margin had similar OS compared to those with low-grade dysplasia (mOS: 78.8 vs. 66.8 months, P=0.344). However, high-grade dysplasia (mOS: 26.1 mo, P=0.001) and invasive cancer (mOS: 25.0 mo, P<0.001) were associated with significantly worse OS compared to no or low-grade dysplasia. Patients who underwent conversion of high-risk margins (high-grade or invasive cancer) to a low-risk margin (low-grade or no dysplasia) after intraoperative frozen section had significantly superior OS compared to those with a high-risk neck margin on final pathology (mOS: 76.9 vs. 26.1 mo P<0.001)., Conclusions: In IPMN-derived PDAC, normal epithelium or low-grade dysplasia at the neck have similar outcomes while pancreatic neck margins with high-grade dysplasia or invasive cancer are associated with poorer outcomes. Conversion of a high-risk to low-risk margin after intraoperative frozen section is associated with survival benefit and should be performed when feasible., Competing Interests: Disclosures: There are no conflicts of interest for any of the authors.Funding: Joseph R. Habib is supported by the NIH T32 grant T32CA193111. Ingmar F. Rompen is supported by the Swiss National Science Foundation (SNSF, grant number 217684). This work was also supported by the Ben and Rose Cole Charitable PRIA Foundation., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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10. Correction: Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design.
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Daamen LA, van Goor IWJM, Groot VP, Andel PCM, Brosens LAA, Busch OR, Cirkel GA, Mohammad NH, Heerkens HD, de Hingh IHJT, Hoogwater F, van Laarhoven HWM, Los M, Meijer GJ, de Meijer VE, Pande R, Roberts KJ, Stoker J, Stommel MWJ, van Tienhoven G, Verdonk RC, Verkooijen HM, Wessels FJ, Wilmink JW, Besselink MG, van Santvoort HC, Intven MPW, and Molenaar IQ
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- 2024
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11. Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design.
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Daamen LA, van Goor IWJM, Groot VP, Andel PCM, Brosens LAA, Busch OR, Cirkel GA, Mohammad NH, Heerkens HD, de Hingh IHJT, Hoogwater F, van Laarhoven HWM, Los M, Meijer GJ, de Meijer VE, Pande R, Roberts KJ, Stoker J, Stommel MWJ, van Tienhoven G, Verdonk RC, Verkooijen HM, Wessels FJ, Wilmink JW, Besselink MG, van Santvoort HC, Intven MPW, and Molenaar IQ
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- Humans, Time Factors, Prospective Studies, Multicenter Studies as Topic, Treatment Outcome, Predictive Value of Tests, Netherlands, United Kingdom, Research Design, Early Detection of Cancer methods, Carcinoma, Pancreatic Ductal surgery, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal diagnostic imaging, Carcinoma, Pancreatic Ductal pathology, Carcinoma, Pancreatic Ductal blood, Pancreatic Neoplasms surgery, Pancreatic Neoplasms pathology, Neoplasm Recurrence, Local, Randomized Controlled Trials as Topic, Pancreatectomy adverse effects, Quality of Life
- Abstract
Background: Disease recurrence remains one of the biggest concerns in patients after resection of pancreatic ductal adenocarcinoma (PDAC). Despite (neo)adjuvant systemic therapy, most patients experience local and/or distant PDAC recurrence within 2 years. High-level evidence regarding the benefits of recurrence-focused surveillance after PDAC resection is missing, and the impact of early detection and treatment of recurrence on survival and quality of life is unknown. In most European countries, recurrence-focused follow-up after surgery for PDAC is currently lacking. Consequently, guidelines regarding postoperative surveillance are based on expert opinion and other low-level evidence. The recent emergence of more potent local and systemic treatment options for PDAC recurrence has increased interest in early diagnosis. To determine whether early detection and treatment of recurrence can lead to improved survival and quality of life, we designed an international randomized trial., Methods: This randomized controlled trial is nested within an existing prospective cohort in pancreatic cancer centers in the Netherlands (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) (Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the "Trials within Cohorts" (TwiCs) design. All PACAP/PACOPS participants with a macroscopically radical resection (R0-R1) of histologically confirmed PDAC, who provided informed consent for TwiCs and participation in quality of life questionnaires, are included. Participants randomized to the intervention arm are offered recurrence-focused surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19-9 testing, and contrast-enhanced computed tomography (CT) of chest and abdomen every three months during the first 2 years after surgery. Participants in the control arm of the study will undergo non-standardized clinical follow-up, generally consisting of clinical follow-up with imaging and serum tumor marker testing only in case of onset of symptoms, according to local practice in the participating hospital. The primary endpoint is overall survival. Secondary endpoints include quality of life, patterns of recurrence, compliance to and costs of recurrence-focused follow-up, and the impact on recurrence-focused treatment., Discussion: The RADAR-PANC trial will be the first randomized controlled trial to generate high level evidence for the current clinical equipoise regarding the value of recurrence-focused postoperative surveillance with serial tumor marker testing and routine imaging in patients after PDAC resection. The Trials within Cohort design allows us to study the acceptability of recurrence-focused surveillance among cohort participants and increases the generalizability of findings to the general population. While it is strongly encouraged to offer all trial participants treatment at time of recurrence diagnosis, type and timing of treatment will be determined through shared decision-making. This might reduce the potential survival benefits of recurrence-focused surveillance, although insights into the impact on patients' quality of life will be obtained., Trial Registration: Clinicaltrials.gov, NCT04875325 . Registered on May 6, 2021., (© 2024. The Author(s).)
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- 2024
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12. Defining the Minimal and Optimal Thresholds for Lymph Node Resection and Examination for Intraductal Papillary Mucinous Neoplasm Derived Pancreatic Cancer: A Multicenter Retrospective Analysis.
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Habib JR, Rompen IF, Kaslow SR, Grewal M, Andel PCM, Zhang S, Hewitt DB, Cohen SM, van Santvoort HC, Besselink MG, Molenaar IQ, He J, Wolfgang CL, Javed AA, and Daamen LA
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Objective: To establish minimal and optimal lymphadenectomy thresholds for intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) and evaluate their prognostic value., Background: Current guidelines recommend a minimum of 12-15 lymph nodes (LNs) in PDAC. This is largely based on pancreatic intraepithelial neoplasia (PanIN)-derived PDAC, a biologically distinct entity from IPMN-derived PDAC., Methods: Multicenter retrospective study including consecutive patients undergoing upfront surgery for IPMN-derived PDAC was conducted. The minimum cut-off for lymphadenectomy was defined as the maximum number of LNs where a significant node positivity difference was observed. Maximally selected log-rank statistic was used to derive the optimal lymphadenectomy cut-off (maximize survival). Kaplan-Meier curves and log-rank tests were used to analyze overall survival (OS) and recurrence-free survival (RFS). Multivariable Cox-regression was used to determine hazard ratios (HR) with 95% confidence intervals (95%CI)., Results: In 341 patients with resected IPMN-derived PDAC, the minimum number of LNs needed to ensure accurate nodal staging was 10 (P=0.040), whereas ≥20 LNs was the optimal number associated with improved OS (80.3 vs. 37.2 mo, P<0.001). Optimal lymphadenectomy was associated with improved OS [HR:0.57 (95%CI 0.39-0.83)] and RFS [HR:0.70 (95%CI 0.51-0.97)] on multivariable Cox-regression. On sub-analysis the optimal lymphadenectomy cut-offs for pancreatoduodenectomy, distal pancreatectomy, and total pancreatectomy were 20 (P<0.001), 23 (P=0.160), and 25 (P=0.008)., Conclusion: In IPMN-derived PDAC, lymphadenectomy with at least 10 lymph nodes mitigates under-staging, and at least 20 lymph nodes is associated with the improved survival. Specifically, for pancreatoduodenectomy and total pancreatectomy, 20 and 25 lymph nodes were the optimal cut-offs., Competing Interests: Disclosures: There are no conflicts of interest for any of the authors. The corresponding authors had full access to all data and take full responsibility for the veracity of the data and statistical analysis., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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13. A nationwide assessment of hepatocellular adenoma resection: Indications and pathological discordance.
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Haring MPD, Elfrink AKE, Oudmaijer CAJ, Andel PCM, Furumaya A, de Jong N, Willems CJJM, Huits T, Sijmons JML, Belt EJT, Bosscha K, Consten ECJ, Coolsen MME, van Duijvendijk P, Erdmann JI, Gobardhan P, de Haas RJ, van Heek T, Lam HD, Leclercq WKG, Liem MSL, Marsman HA, Patijn GA, Terkivatan T, Zonderhuis BM, Molenaar IQ, Te Riele WW, Hagendoorn J, Schaapherder AFM, IJzermans JNM, Buis CI, Klaase JM, de Jong KP, and de Meijer VE
- Subjects
- Humans, Male, Adult, Middle Aged, Retrospective Studies, Magnetic Resonance Imaging methods, Adenoma, Liver Cell diagnostic imaging, Adenoma, Liver Cell surgery, Liver Neoplasms diagnostic imaging, Liver Neoplasms surgery, Carcinoma, Hepatocellular pathology
- Abstract
Hepatocellular adenomas (HCAs) are benign liver tumors associated with bleeding or malignant transformation. Data on the indication for surgery are scarce. We analyzed indications and outcome of patients operated for HCAs < 50 mm compared to HCAs ≥ 50 mm. Changes in final postoperative diagnosis were assessed. We performed a retrospective study that included patients who underwent resection for (suspected) HCAs in the Netherlands from 2014 to 2019. Indication for resection was analyzed and stratified for small (<50 mm) and large (≥50 mm) tumors. Logistic regression analysis was performed on factors influencing change in tumor diagnosis. Out of 222 patients who underwent surgery, 44 (20%) patients had a tumor <50 mm. Median age was 46 (interquartile range [IQR], 33-56) years in patients with small tumors and 37 (IQR, 31-46) years in patients with large tumors ( p = 0.016). Patients with small tumors were more frequently men (21% vs. 5%, p = 0.002). Main indications for resection in patients with small tumors were suspicion of (pre)malignancy (55%), (previous) bleeding (14%), and male sex (11%). Patients with large tumors received operations because of tumor size >50 mm (52%), suspicion of (pre)malignancy (28%), and (previous) bleeding (5.1%). No difference was observed in HCA-subtype distribution between small and large tumors. Ninety-six (43%) patients had a postoperative change in diagnosis. Independent risk factors for change in diagnosis were tumor size <50 mm (adjusted odds ratio [aOR], 3.4; p < 0.01), male sex (aOR, 3.7; p = 0.03), and lack of hepatobiliary contrast-enhanced magnetic resonance imaging (CE-MRI) (aOR, 1.8; p = 0.04). Resection for small (suspected) HCAs was mainly indicated by suspicion of (pre)malignancy, whereas for large (suspected) HCAs, tumor size was the most prevalent indication. Male sex, tumor size <50 mm, and lack of hepatobiliary CE-MRI were independent risk factors for postoperative change in tumor diagnosis., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc on behalf of the American Association for the Study of Liver Diseases.)
- Published
- 2022
- Full Text
- View/download PDF
14. Safety and feasibility of rigid fixation by SternaLock Blu plates during the modified Ravitch procedure: a pilot study.
- Author
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de Loos ER, Andel PCM, Daemen JHT, Maessen JG, Hulsewé KWE, and Vissers YLJ
- Abstract
Background: Patients with anterior chest wall deformities unsuitable for minimally invasive repair are commonly treated by the modified Ravitch procedure. Although rigid plate fixation of the sternal osteotomy has previously shown to facilitate adequate sternal union, its use is troubled by an implant removal rate of up to 23% due to local complaints or complications associated with bulky plates. In contrast, the use of thinner and therefore biomechanically weaker plates may result in a higher incidence of non- or mal-union. In this pilot study, we evaluate the feasibility, efficacy and safety of rigid sternal fixation by thin pre-shaped anatomical locking plates during the modified Ravitch procedure., Methods: Between June 2018 and December 2019, all consecutive patients who underwent anterior chest wall deformity repair by the modified Ravitch procedure in our tertiary referral centre were included. Data was collected retrospectively. All pectus types were included. The sternal osteotomy was fixated using thin SternaLock Blu plates. Patients were followed for at least one year., Results: Nine patients were included. The group consisted of six male and three female patients, with a median age of 20 years [interquartile range (IQR), 16-35 years]. Median duration of follow-up was 25 months (IQR, 16-28 months). No intraoperative complications occurred. No patients presented with symptomatic non- or mal-union. Plate removal was performed in one patient for atypical pain without relief. No other postoperative complications occurred., Conclusions: Based on these pilot results, thin SternaLock Blu plates are deemed to be safe and effective in providing adequate rigid fixation of the sternal osteotomy during the modified Ravitch procedure. Compared to literature, the need for plate removal within 25 months after surgery was reduced., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-21-284). The authors have no conflicts of interest to declare., (2021 Journal of Thoracic Disease. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
15. A case series: xiphoidectomy for xiphodynia, a rare thoracic wall disorder.
- Author
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Bakens MJAM, Andel PCM, Daemen JHT, Hulsewé KWE, Vissers YLJ, and de Loos ER
- Abstract
Background: Xiphodynia is a rare musculoskeletal disorder characterized by pain at the lower anterior chest or epigastric region. Treatment options include oral analgesics, local injection with analgesic or laser therapy. Yet, these often provide only short-term symptom relieve. A definite reduction in pain sensation might be achieved by performing a xiphoidectomy, though studies on its safety and efficacy are scarce. In the current single-centre study the outcomes of xiphoidectomy for xiphodynia are retrospectively assessed., Methods: All patients undergoing xiphoidectomy for xiphodynia between April 2013 and February 2020 at Zuyderland Medical Centre, Heerlen, the Netherlands, were included in this case series. Pain scores using the Numeric Rating Scale were assessed preoperatively and postoperatively and submitted to the Wilcoxon signed rank test. A clinically significant improvement was defined as a 2-point decrease in Numeric Rating Scale score. In addition, surgical outcomes, including complications and duration of surgery were extracted from the patient records., Results: A total of 19 patients underwent xiphoidectomy for xiphodynia. The follow-up ranged from 1 to 83 months. Seventeen out of 19 patients showed a clinically relevant improvement in Numeric Rating Scale pain scores where the overall pain scores also revealed a statistically significant decrease from 8 (interquartile range, 7-8) to 0 (interquartile range, 0-0; P<0.001) after surgery. Median procedure time was 29 minutes (interquartile range, 24-38 minutes) and no postoperative complications occurred., Conclusions: Xiphoidectomy for xiphodynia is a safe and effective surgical procedure with good outcomes on pain relief. Though, future comparative studies are urged to elucidate its value among other treatment options., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-20-3396). The authors have no conflicts of interest to declare., (2021 Journal of Thoracic Disease. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
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