7 results on '"Verdonk, RC"'
Search Results
2. 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.
- Author
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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
- Subjects
- 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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3. Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial.
- Author
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Kastelijn JB, van de Pavert YL, Besselink MG, Fockens P, Voermans RP, van Wanrooij RLJ, de Wijkerslooth TR, Curvers WL, de Hingh IHJT, Bruno MJ, Koerkamp BG, Patijn GA, Poen AC, van Hooft JE, Inderson A, Mieog JSD, Poley JW, Bijlsma A, Lips DJ, Venneman NG, Verdonk RC, van Dullemen HM, Hoogwater FJH, Frederix GWJ, Molenaar IQ, Welsing PMJ, Moons LMG, van Santvoort HC, and Vleggaar FP
- Subjects
- Humans, Endosonography, Quality of Life, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Gastric Bypass adverse effects, Gastric Outlet Obstruction diagnostic imaging, Gastric Outlet Obstruction etiology, Gastric Outlet Obstruction surgery
- Abstract
Background: Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance status is a laparoscopic surgical gastrojejunostomy (SGJ). Recently, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) emerged as a promising alternative to the surgical approach. The present study aims to compare these treatment modalities in terms of efficacy, safety, and costs., Methods: The ENDURO-study is a multicentre, open-label, parallel-group randomized controlled trial. In total, ninety-six patients with gastric outlet obstruction caused by an irresectable or metastasized malignancy will be 1:1 randomized to either SGJ or EUS-GE. The primary endpoint is time to tolerate at least soft solids. The co-primary endpoint is the proportion of patients with persisting or recurring symptoms of gastric outlet obstruction for which a reintervention is required. Secondary endpoints are technical and clinical success, quality of life, gastroenterostomy dysfunction, reinterventions, time to reintervention, adverse events, quality of life, time to start chemotherapy, length of hospital stay, readmissions, weight, survival, and costs., Discussion: The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions for persistent or recurrent obstructive symptoms in patients with malignant GOO. This trial aims to guide future treatment strategies and to improve quality of life in a palliative setting., Trial Registration: International Clinical Trials Registry Platform (ICTRP): NL9592. Registered on 07 July 2021., (© 2023. BioMed Central Ltd., part of Springer Nature.)
- Published
- 2023
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4. Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial.
- Author
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de Rijk FEM, van Veldhuisen CL, Besselink MG, van Hooft JE, van Santvoort HC, van Geenen EJM, van Werkhoven CH, de Jonge PJF, Bruno MJ, and Verdonk RC
- Subjects
- Humans, Pancreas, Pain, Nutritional Status, Randomized Controlled Trials as Topic, Quality of Life, Pancreatitis, Chronic diagnosis, Pancreatitis, Chronic therapy
- Abstract
Background: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP., Methods: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial., Discussion: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice., Trial Registration: ISRCTN, ISRCTN13042622. Registered on 5 September 2020., (© 2023. The Author(s).)
- Published
- 2023
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5. Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial.
- Author
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Snijders RJALM, Stoelinga AEC, Gevers TJG, Pape S, Biewenga M, Verdonk RC, de Jonge HJM, Vrolijk JM, Bakker SF, Vanwolleghem T, de Boer YS, Pronk MAMCB, Beuers UHW, van der Meer AJ, van Gerven NMF, Sijtsma MGM, Verwer BJ, Gisbertz IAM, Bartelink M, van den Brand FF, Sebib Korkmaz K, van den Berg AP, Guichelaar MMJ, Soufidi K, Levens AD, van Hoek B, and Drenth JPH
- Subjects
- Adult, Humans, Mycophenolic Acid adverse effects, Azathioprine adverse effects, Quality of Life, Immunosuppressive Agents adverse effects, Treatment Outcome, Severity of Illness Index, Prednisolone adverse effects, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Hepatitis, Autoimmune diagnosis, Hepatitis, Autoimmune drug therapy, End Stage Liver Disease
- Abstract
Background: Currently, the standard therapy for autoimmune hepatitis (AIH) consists of a combination of prednisolone and azathioprine. However, 15% of patients are intolerant to azathioprine which necessitates cessation of azathioprine or changes in therapy. In addition, not all patients achieve complete biochemical response (CR). Uncontrolled data indicate that mycophenolate mofetil (MMF) can induce CR in a majority of patients. Better understanding of first-line treatment and robust evidence from randomised clinical trials are needed. The aim of this study was to explore the potential benefits of MMF as compared to azathioprine, both combined with prednisolone, as induction therapy in a randomised controlled trial in patients with treatment-naive AIH., Methods: CAMARO is a randomised (1:1), open-label, parallel-group, multicentre superiority trial. All patients with AIH are screened for eligibility. Seventy adult patients with AIH from fourteen centres in the Netherlands and Belgium will be randomised to receive MMF or azathioprine. Both treatment arms will start with prednisolone as induction therapy. The primary outcome is biochemical remission, defined as serum levels of alanine aminotransferase and immunoglobulin G below the upper limit of normal. Secondary outcomes include safety and tolerability of MMF and azathioprine, time to remission, changes in Model For End-Stage Liver Disease (MELD)-score, adverse events, and aspects of quality of life. The study period will last for 24 weeks., Discussion: The CAMARO trial investigates whether treatment with MMF and prednisolone increases the proportion of patients in remission compared with azathioprine and prednisolone as the current standard treatment strategy. In addition, we reflect on the challenges of conducting a randomized trial in rare diseases., Trial Registration: EudraCT 2016-001038-91 . Prospectively registered on 18 April 2016., (© 2022. The Author(s).)
- Published
- 2022
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6. Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial.
- Author
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Mackay TM, Smits FJ, Latenstein AEJ, Bogte A, Bonsing BA, Bos H, Bosscha K, Brosens LAA, Hol L, Busch ORC, Creemers GJ, Curvers WL, den Dulk M, van Dieren S, van Driel LMJW, Festen S, van Geenen EJM, van der Geest LG, de Groot DJA, de Groot JWB, Haj Mohammad N, Haberkorn BCM, Haver JT, van der Harst E, Hemmink GJM, de Hingh IH, Hoge C, Homs MYV, van Huijgevoort NC, Jacobs MAJM, Kerver ED, Liem MSL, Los M, Lubbinge H, Luelmo SAC, de Meijer VE, Mekenkamp L, Molenaar IQ, van Oijen MGH, Patijn GA, Quispel R, van Rijssen LB, Römkens TEH, van Santvoort HC, Schreinemakers JMJ, Schut H, Seerden T, Stommel MWJ, Ten Tije AJ, Venneman NG, Verdonk RC, Verheij J, van Vilsteren FGI, de Vos-Geelen J, Vulink A, Wientjes C, Wit F, Wessels FJ, Zonderhuis B, van Werkhoven CH, van Hooft JE, van Eijck CHJ, Wilmink JW, van Laarhoven HWM, and Besselink MG
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Biliary Tract Surgical Procedures, Carcinoma, Pancreatic Ductal epidemiology, Child, Child, Preschool, Cluster Analysis, Drainage, Enzyme Replacement Therapy, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Multicenter Studies as Topic, Neoadjuvant Therapy, Netherlands epidemiology, Palliative Care, Pancreatic Neoplasms epidemiology, Pancreaticoduodenectomy, Patient Compliance, Randomized Controlled Trials as Topic, Stents, Treatment Outcome, Young Adult, Carcinoma, Pancreatic Ductal mortality, Carcinoma, Pancreatic Ductal therapy, Health Plan Implementation, Pancreatic Neoplasms mortality, Pancreatic Neoplasms therapy, Quality of Life
- Abstract
Background: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life., Methods/design: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide., Discussion: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life., Trial Registration: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.
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- 2020
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7. Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.
- Author
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Smeets XJNM, da Costa DW, Fockens P, Mulder CJJ, Timmer R, Kievit W, Zegers M, Bruno MJ, Besselink MGH, Vleggaar FP, van der Hulst RWM, Poen AC, Heine GDN, Venneman NG, Kolkman JJ, Baak LC, Römkens TEH, van Dijk SM, Hallensleben NDL, van de Vrie W, Seerden TCJ, Tan ACITL, Voorburg AMCJ, Poley JW, Witteman BJ, Bhalla A, Hadithi M, Thijs WJ, Schwartz MP, Vrolijk JM, Verdonk RC, van Delft F, Keulemans Y, van Goor H, Drenth JPH, and van Geenen EJM
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- Administration, Rectal, Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Data Collection, Humans, Middle Aged, Multicenter Studies as Topic, Ringer's Lactate adverse effects, Sample Size, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Pancreatitis prevention & control, Randomized Controlled Trials as Topic, Ringer's Lactate administration & dosage
- Abstract
Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP., Methods: The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness., Discussion: The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs., Trial Registration: EudraCT: 2015-000829-37 . Registered on 18 February 2015., Isrctn: 13659155 . Registered on 18 May 2015.
- Published
- 2018
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