Objective: To compare endoscopic and surgical drainage of the pancreatic duct for ductal decompression in patients with severe pain due to chronic pancreatitis and a dilated pancreatic duct.
Design: Randomized clinical trial.
Method: All symptomatic patients with chronic pancreatitis and a distal obstruction of the pancreatic duct, but without an inflammatory mass, were eligible for this study. Patients were randomized to endoscopic transampullary pancreatic duct drainage or to operative pancreaticojejunostomy. The primary end point was the average Izbicki pain score, measured during 2 years of follow-up. The secondary endpoints were pain relief at the end of follow-up, physical and mental health, morbidity, mortality, hospital stay and number of procedures performed.
Results: Of 118 patients who were evaluated between January 2000-October 2004 39 patients were randomized; 19 were treated endoscopically (16 of whom underwent lithotripsy) and 20 by operative pancreaticojejunostomy. During 24 months of follow-up, compared with endoscopic drainage, surgery was associated with lower Izbicki pain scores (51 versus 25; p < 0.001) and better SF-36 physical health summary scores (p = 0.003). Furthermore, at the end of follow-up, pain relief was achieved in 32% of patients randomized to endoscopic drainage and 75% of patients randomized to surgical drainage (p = 0.007). Complication rates and hospital stay were similar, but endoscopic treatment required more procedures (median 8 versus 3; p < 0.001).