NEW YORK (Reuters Health) – Protease inhibitors do not prevent complications associated with endoscopic retrograde cholangiopancreatography (ERCP), researchers from Japan report in the December 8th Gastrointestinal Endoscopy.

Previous studies concerning the prophylactic efficacy of protease inhibitors for post-ERCP pancreatitis yielded inconsistent results, so Dr. Takeshi Seta from Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan and Dr. Yoshinori Noguchi from Nagoya Daini Red Cross Hospital, Aichi, Japan performed a meta-analysis to evaluate 3 protease inhibitors (aprotinin, gabexate, and ulinastatin) for preventing complications associated with ERCP.

Their analysis included 18 articles with a total of 4966 patients, and the quality of the studies was judged to be relatively low overall.

Although the results of 15 studies showed a significant risk reduction for ERCP-associated pancreatitis, subgroup analysis of 8 high-quality studies showed only a borderline significant efficacy of protease inhibitors with moderate heterogeneity.

Subgroup analysis of 8 gabexate studies and 2 high-quality ulinastatin studies yielded nonsignificant results, although subgroup analysis of all 5 ulinastatin suggested significant efficacy.

Overall results and subgroup analysis of gabexate and ulinastatin studies revealed no significant risk reduction for ERCP-associated hyperamylasemia, ERCP-associated abdominal pain, or ERCP-associated mortality.

Sensitivity analysis demonstrated a decrease in effect size and statistical significance with increasing study quality.

“At present,” the researchers conclude, “there is no solid evidence to support the use of protease inhibitors for preventing complications of pancreatitis, hyperamylasemia, abdominal pain, or death associated with ERCP.”

“Although overall and ulinastatin subgroup analysis showed a significant risk reduction for pancreatitis,” they explain, “it seems very possible that low-quality primary studies produced a veneer of efficacy.”

Gastrointest Endosc 8 December 2010.