What is this study trying to find out about Endoscopic Retrograde Cholangiopancreatography?

This study is comparing the risk of pancreatitis after pancreatic sphincterotomy performed for difficult cannulation, with or without placement of a protective pancreatic stent. Researchers want to understand if the stent can reduce complications during this procedure. The study is sponsored by Helsinki University Central Hospital.

Who may be eligible for this Endoscopic Retrograde Cholangiopancreatography clinical trial?

Adults aged 18 to 100 years with a nafve papilla who need common bile duct cannulation during ERCP may be eligible. People with recent acute pancreatitis or those who do not consent cannot participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Endoscopic Retrograde Cholangiopancreatography clinical trial?

Study-related care, including the procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 100Years

All Genders

ID04408482

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation

Led by Helsinki University Central Hospital · Updated on 2026-03-03

268

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether placing a prophylactic pancreatic stent reduces the risk of post-ERCP pancreatitis PEP after pancreatic sphincterotomy performed due to difficult cannulation. The study compares two groups of patients undergoing pancreatic sphincterotomy those who receive a pancreatic stent and those who do not. The definition of difficult cannulation follows established medical literature. Participants will undergo pancreatic sphincterotomy for difficult cannulation of the biliary duct. One group will have only the sphincterotomy procedure, while the other group will have both sphincterotomy and prophylactic pancreatic stent placement. The study uses a randomized design without masking or blinding, and the intervention involves device-assisted biliary cannulation using a sphincterotome. During the 30 days following the procedure, researchers will monitor participants for the rate of post-ERCP pancreatitis, which is the primary outcome measure. Participants are consecutive patients with a nafve papilla requiring common bile duct cannulation. The study involves follow-up assessments to evaluate safety and effectiveness of the stent placement in preventing pancreatitis within the first month after treatment.

CONDITIONS

Brief Title

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Who Can Participate

Age: 18Years - 100Years

All Genders

Eligibility Criteria

You may qualify if you...

Consecutive patients with nafve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.

You will not qualify if you...

Age below 18 years
Acute pancreatitis
No consent to the study

Research Team

Andrea Tenca, MD, PhD

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