Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-05-01

Brief Summary

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The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.

If there is a comparison group: Researchers will compare \[rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.\] to see if \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rectal indomethacin

Group Type ACTIVE_COMPARATOR

Rectal Indomethacin

Intervention Type DRUG

Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis

Pancreatic duct stent and rectal indomethacin

Group Type ACTIVE_COMPARATOR

Prophylactic Pancreatic duct stenting

Intervention Type PROCEDURE

Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis

Interventions

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Rectal Indomethacin

Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis

Intervention Type DRUG

Prophylactic Pancreatic duct stenting

Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis

Intervention Type PROCEDURE

Other Intervention Names

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Rectal indomethacin 100 mg

Eligibility Criteria

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Inclusion Criteria

1. Suspected sphincter of Oddi dysfunction
2. History of post ERCP Pancreatitis
3. Pancreatic instrumentation or sphincterotomy.
4. Precut sphincteroyomy
5. Difficult cannulation defined by more than 5 cannulation attempts
6. The use of double wire technique in bile duct access
7. At least 2 of the followings including

1. Female age \< 50 year
2. 3 pancreatogram
3. Acinarization (Contrast injection to tail of pancreas
4. Normal serum bilirubin
5. Guidewire to the tail of pancreas or secondary branches

Exclusion Criteria

1. Patient planned for pancreatic stenting
2. Without informed consent
3. Age \< 18 years
4. Pregnant women
5. Lactating women
6. Patient with altered anatomy
7. Contraindications to the use of NSAIDS
8. Renal failure
9. Ongoing or recent hospitalisation for acute pancreatitis
10. Allergy to aspirin or NSAIDs
11. known chronic calcific pancreatitis -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No