Introduction

​Post-ERCP pancreatitis (PEP) is still the most common major complication of ERCP despite technical advancements and meticulous patient selection. The efficacy of the existing techniques is conflicting.

Aims & Methods

We aimed to compare the efficacy of peripapillary epinephrine injection in combination with rectal diclofenac for the prevention of PEP in high-risk patients .
Methods Between January 2023 and August 2023, a total of 378 patients were enrolled. We calculated that 189 patients in each group (rectal diclofenac – Group A and peripapillary epinephrine injection plus rectal indomethacin – Group B) would suffice based on a previous study by our group (α:0.05, 80% power). Patients with a non-naive papillae, ampulla of Vater cancer, biliary pancreatitis, altered anatomy, pregnancy, and pancreatic diseases such as chronic pancreatitis were excluded. Patients were assigned in a 1:1 simple randomized fashion. The primary outcome was the rate of PEP. Secondary outcomes were the rate of hyperamylasemia and rates of other adverse events.

Results

​Demographic characteristics, indications, and procedure-related risk factors were similar between the groups. The overall success rate of selective cannulation was 99.2% in Group A and 99.3% in Group B (p=0.997). PEP occurred in 9 of the 189 (4.8%) patients in Group A and 2 of the 189 (0.5%) patients in Group B. All cases were mild and managed conservatively. The rate of post-procedure 4th-hour hyperamylasemia was significantly higher in Group A (19% vs 5%, p<0.001). Postsphincterotomy-related bleeding developed in 5 patients in Group A (2.64%) but none of the patients had bleeding in Group B. Stapfer type-II perforation occurred in two patients in each group. No major cardiac adverse events-related to epinephrine injection were detected in Group B.

Conclusion

Compared to rectal diclofenac, peripapillary epinephrine injection significantly reduced the incidence of PEP, post-procedure hyperamylasemia, and sphincterotomy-related bleeding.