A randomized controlled trial of pentoxifylline for the prevention of post-ERCP pancreatitis

BACKGROUND: Pentoxifylline can ameliorate pancreatitis in animal models because of its anti-tumor necrosis factor properties. OBJECTIVE: Our purpose was to study the safety and efficacy of pentoxifylline in the prevention of post-ERCP pancreatitis. DESIGN: Patients due to undergo ERCP for various indications were randomized to receive pentoxifylline 400 mg orally 3 times, beginning the day before ERCP (2 and 10 pm) until the night after the procedure (6 am and 2 and 10 pm) or to receive no preventive medication. Serum amylase values were determined before and 6 and 24 hours after ERCP. Diagnosis and grading of the severity of complications was performed according to consensus criteria. PATIENTS: One hundred fifty-eight patients received pentoxifylline (group A) and 162 had no medication (group B). The groups were similar in distributions of sex, biliary sphincterotomy, pancreatography, pancreatic duct cannulations, stone extraction, stent placement, and presence of periampullary diverticulum. Group A patients were younger (mean age 63 vs 68 years, P<.05) and biliary colic was a more frequent indication (30 vs 12, P<.05). RESULTS: Nine (5.6%) patients in group A and 5 (3%) in group B had pancreatitis (2 and 1 severe, respectively; P=.28). Serum amylase values were similar in baseline and 6- and 24-hour samples. Two (1.2%) patients in group A and 7 (4.3%) in group B had hemorrhage. LIMITATIONS: This was not a double-blind trial. CONCLUSIONS: In this study pentoxifylline did not protect against post-ERCP pancreatitis or hyperamylasemia.