Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial

BMC Gastroenterology

Study Protocol

Marcel GW Dijkgraaf¹  Oliver H Wilder-Smith²  Hein G Gooszen³  Paul Fockens⁴  Jeanin E van Hooft⁴  Robin Timmer⁵  Marco J Bruno⁶  Jan W Poley⁶  Yolande Keulemans⁷  Hendrik M van Dullemen⁸  Peter D Siersema⁹  Frank P Vleggaar⁹  Marja A Boermeester^1,10  Dirk J Gouma^1,10  Olivier RC Busch^1,10  Yama Issa^1,10  Marc G Besselink^1,10  Usama Ahmed Ali^1,11  Casper H van Eijck^1,12  Vincent B Nieuwenhuijs^1,13  Cornelis HC Dejong^1,14  Harry van Goor^1,15  Hjalmar van Santvoort^1,16 

[1] Clinical Research Unit, Academic Medical Center Amsterdam, PO 22660, 1100 DD, Amsterdam, The Netherlands;Department of Anesthesia, Radboud University Nijmegen Medical Center, HP 630, PO 9101, 6500 HB, Nijmegen, The Netherlands;Department of Evidence Based Surgery, Radboud University Nijmegen Medical Center, HP 630, PO 9101, 6500 HB, Nijmegen, The Netherlands;Department of Gastroenterology, Academic Medical Center Amsterdam, PO 22660, 1100 DD, Amsterdam, The Netherlands;Department of Gastroenterology, Antonius Ziekenhuis, PO 2500, 3430 EM, Nieuwegein, The Netherlands;Department of Gastroenterology, Erasmus Medical Center Rotterdam, PO 2040, 3000 CA, Rotterdam, The Netherlands;Department of Gastroenterology, Maastricht University Medical Center, PO 5800, 6202 AZ, Maastricht, The Netherlands;Department of Gastroenterology, University Medical Center Groningen, PO 30001, 9700 RB, Groningen, The Netherlands;Department of Gastroenterology, University Medical Center Utrecht, PO 85500, 3508 GA, Utrecht, The Netherlands;Department of Surgery, Academic Medical Center Amsterdam, PO 22660, 1100 DD, Amsterdam, The Netherlands;Department of Surgery, Academic Medical Center Amsterdam, PO 22660, 1100 DD, Amsterdam, The Netherlands;Department of Surgery, University Medical Center Utrecht, HP G04.228, PO 85500, 3508 GA, Utrecht, The Netherlands;Department of Surgery, Erasmus Medical Center Rotterdam, PO 2040, 3000 CA, Rotterdam, The Netherlands;Department of Surgery, Isala Ziekenhuis, PO 105008000 GM, Zwolle Zwolle, The Netherlands;Department of Surgery, University Medical Center Groningen, PO 30001, 9700 RB, Groningen, The Netherlands;Department of Surgery, Maastricht University Medical Center, PO 5800, 6202 AZ, Maastricht, The Netherlands;Department of Surgery, Radboud University Nijmegen Medical Center, HP 630, PO 9101, 6500 HB, Nijmegen, The Netherlands;Department of Surgery, University Medical Center Utrecht, HP G04.228, PO 85500, 3508 GA, Utrecht, The Netherlands;

关键词: Chronic pancreatitis;    Pain;    Surgical management;    Surgery;    Endoscopic treatment;    Endoscopy;    ERCP;    Opioid;    Pancreaticojejunostomy;    Frey procedure;   

DOI  :  10.1186/1471-230X-13-49

 received in 2013-02-18, accepted in 2013-03-07,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundIn current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis.Methods/designThe ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥ 5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥ 4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%).DiscussionThe ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice.Trial registrationISRCTN: ISRCTN45877994

【 授权许可】

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© Ahmed Ali et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.