Early endoscopic intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial.

Objective: To test the hypothesis that early endoscopic intervention, performed on patients with acute gallstone pancreatitis and biliopancreatic obstruction, reduces systemic and local inflammation.

Summary Background Data: The role of early endoscopic intervention, in the treatment of acute gallstone pancreatitis, remains controversial. Previous randomized trials have not focused on the subgroup of patients with clinical evidence of biliopancreatic obstruction.

Methods: This single-center randomized clinical trial was performed between May 2000 and September 2005. Of 238 patients, admitted within 48 hours after the onset of acute gallstone pancreatitis, 103 with a distal bile duct measuring > or =8 mm combined with a total serum bilirubin > or =1.20 mg/dL, were randomized to receive either endoscopic retrograde cholangiopancreatography followed by endoscopic papillotomy for bile duct stones (EEI, n = 51) or early conservative management (ECM, n = 52). Patients with clinical evidence of coexisting acute cholangitis were excluded. Outcome measures included changes in organ failure score and computed tomography (CT) severity index during the first week after admission, incidence of local complications, and overall morbidity and mortality.

Results: The incidence of bile duct stones at EEI was 72% and 40% of patients in the ECM group had persisting bile duct stones at elective biliary surgery. No significant differences were found between the EEI and ECM groups regarding changes in mean organ failure score (P = 0.87), mean CT severity index (P = 0.88), incidence of local complications (6% vs. 6%, P = 0.99), overall morbidity (21% vs. 18%, P = 0.80), and mortality (6% vs. 2%, P = 1).

Conclusions: The present study failed to provide evidence that early endoscopic intervention reduces systemic and local inflammation in patients with acute gallstone pancreatitis and biliopancreatic obstruction. If acute cholangitis can be safely excluded, early endoscopic intervention is not mandatory and should not be considered a standard indication.