Clinical trial comparing commonly used drugs for preventing pancreatitis occurring after ERCP (a type of endoscopy) procedure

Not Applicable

• Conditions: Health Condition 1: null- Post ERCP Pancreatitis

• Registration Number: CTRI/2014/11/005191
• Lead Sponsor: Johns Hopkins University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 948

Inclusion Criteria

Major inclusion criteria (If patients meet at least 1 of the criteria)

1. History of PEP

2. Pancreatic sphincterotomy

3. Pre-cut sphincterotomy

4. Difficult cannulation (more than 5 attempts or more than 10 minutes to cannulate)

5. Failed cannulation

6. Pneumatic dilation of an intact sphincter

7. Sphincter of Oddi dysfunction of Type I or Type II.

Minor inclusion criteria (If patients meet at least 2 of the criteria)

1. Age less than 50 and Female gender

2. History of acute pancreatitis (at least 2 episodes)

3. Greater than or equal to 3 pancreatic injections (with at least 1 injection in tail)

4. Pancreatic acinarization

5. Pancreatic Brush Cytology

Exclusion Criteria

1.Unwillingness or inability to consent for the study

2.Age less than 18 years

3.Intrauterine pregnancy

4.Breastfeeding mother

5.Standard contraindications to ERCP

6.Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine

7.Chronic renal disease (Cr greater than 1.8)

8.Active or recent (within 4 weeks) gastrointestinal hemorrhage

9.Acute pancreatitis (lipase peak) within 72 hours

10.Known chronic calcific pancreatitis

11.Pancreatic head mass

12.Receiving pancreatic duct stent placement for any indication

13.Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum

14.ERCP for pancreatic/biliary stent removal or exchange without anticipated pancreatogram

15.Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram

16.Anticipated inability to follow protocol

17.Sphincter of Oddi dysfunction of Type III

Study & Design

• Study Type: Interventional
• Study Design: Not specified