Cold water papilla irrigation in the prevention of post ERCP complications – FREEZE PAPILLA STUDY

Aims Endoscopic retrograde cholangiopancreatography (ERCP) is associated with a considerable complication’s rate, being acute pancreatitis (PEP) one of the most common. There are several measures described in the literature to prevent this event, including: vigorous hidration, rectal indomethacin and pancreatic stenting. Recently there has been a growing interest in the irrigation of the papilla with cold water. We intended to evaluate the efficacy of cold water irrigation of the papilla in the prevention of post ERCP complications. We defined the rate of acute pancreatitis as the primary outcome and the occurrence of post ERCP bleeding and acute cholangitis as the secondary outcomes.

Methods Prospective study at an high volume ERCP center (> 400/year). Patients with native papilla submitted to ERCP between january 2023 and june 2024 were randomized in two groups: irrigation of the papilla with 250 mL of cold water at the end of the procedure (intervention group) and no irrigation (control group). We registered the demographic characteristics of the population, indication for ERCP, time of canulation and total procedure, endoscopist expertise and prophilatic measures used. Then we compared the rate of complications of the two groups and evaluate the effect of cold water irrigation.

Results A total of 161 patients were included (mean age 68 years; 54,7% female): 84 (52,2%) in the intervention group and 77 (47,8%) in the control group. The groups didn’t have any statistically significant difference between them (p>0,05). The most frequent indication for ERCP was choledocholithiasis (65,2%; n=105). There were no differences in cannulation time (p=0,675), total procedure time (p=0,813) or endoscopist expertise (p=0,948). PEP was more frequent in the control group (6,5%; n=5) than in the intervention group (3,6%; n=3), which shows a tendency for the reduction of the risk of PEP (OR 0,53; IC95% 0,123-2,31), without reaching statistic significancy. All PEP were mild. We didn’t find anestehesic complications related to the instilation of water in the duodenum neither post-ERCP bleeding or cholangitis.

Conclusions The irrigation of the papilla with cold water appears to be a safe and potencially effective strategy in the prevention of PEP in conjunction with the other established measures. The continuity of this study will allow us to obtain more conclusive results about the efficacy of this measure.

Publication History

Article published online:
27 March 2025