Chronic Pancreatitis Clinical Trial
Official title:
Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis
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.
This study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period. ;
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