Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Changhai Hospital; Eastern Hepatobiliary Surgery Hospital; Tianjin Union Medical Center; Xijing Hospital; Zhejiang University
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

presence of one of the following risk factors for Post ERCP Pancreatitis

1. sphincter of Oddi dysfunction

2. history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,

3. difficult cannulation defined by >5 cannulation attempts

4. the use of double wire technique in bile duct access

5. at least 2 of the followings including i) female age<50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv） normal bilirubin； v）guidewire to the tail of pancreas or secondary branches.

Exclusion Criteria:

• patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,

• without informed consents from patient or next of kin

• age <18

• pregnant or lactating women

• patients with altered anatomy except except Billroth I and II gastrectomy

• contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine > 140)

• known NSAID allergy

• incipient heart failure.