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The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis

University Hospital, Lille · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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clinical-trialendoscopynasurgery
Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures. The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis. The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.
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