Prophylactic effect of rectal indomethacin plus nitroglycerin administration for preventing pancreatitis after endoscopic retrograde cholangiopancreatography in female patients.

Background: Prophylactic pancreatic stent placement (PSP) and rectal indomethacin suppository are recommended to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Clinical trials on the use of nitroglycerin to reduce PEP have reached no definitive conclusion. Our study aimed to determine whether treatment with rectal indomethacin plus nitroglycerin could eliminate the need for PSP in patients.
Methods: In this randomized clinical trial, patients were allocated into groups using a random number table, with each patient receiving a pre-made envelope containing their intervention prior to ERCP. The three treatment groups were: the placebo group, the indomethacin + nitroglycerin group, and the PSP group. The subjects were assessed for PEP and its severity by a panel of independent and blinded adjudicators.
Results: A total of 526 patients were eligible for inclusion. The placebo group included 176 patients, the indomethacin + nitroglycerin group included 176 patients and the PSP group included 174.A diagnosis of PEP was made in 64 (12.2%) cases. The rate of PEP in the three study groups placebo group, indomethacin + nitroglycerin group and the PSP group was 19.3%, 5.1%, and 12.1%, respectively.
Conclusions: The risk of post-ERCP pancreatitis in the indomethacin + nitroglycerin group was 7% lower than that in the PSP. Indomethacin + nitroglycerin is superior to PSP in preventing and relieving the severity of post-ERCP pancreatitis in patients with difficult intubation. Indomethacin plus nitroglycerin can avoid the need for PSP in the prevention of post-ERCP pancreatitis.
Trial Registration: Current Controlled Trials ChiCTR2000033944.