Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis

NCT07826026 | Not Yet Recruiting DMC

• 1 other identifier: N-ICE
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-endoscopic retrograde cholangiopancreatography pancreatitis (post-ERCP pancreatitis, or PEP) is inflammation of the pancreas that can occur after an ERCP procedure. Rectal indomethacin is commonly given around the time of ERCP to help reduce this risk, but pancreatitis can still occur despite this treatment. The purpose of this randomized clinical trial is to determine whether adding ice water irrigation of the papilla at the end of ERCP further reduces the risk of post-ERCP pancreatitis compared with rectal indomethacin alone. The papilla is the small opening in the intestine where the bile duct and pancreatic duct drain. Participants will be randomly assigned to one of two groups. Both groups will receive rectal indomethacin 100 mg. In the intervention group, the doctor will also irrigate the papilla with a total of 250 mL of ice water immediately after the ERCP. Participants and the study team members who assess study outcomes will not know which treatment group the participant was assigned to. Participants will be assessed after ERCP and followed for up to 30 days for pancreatitis and other complications.

Conditions

Pancreatitis

Keywords

Post-ERCP pancreatitis; Endoscopic retrograde cholangiopancreatography; Rectal indomethacin; Papillary cryoprevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-ERCP Pancreatitis

  Post-ERCP pancreatitis will be defined as new abdominal pain after ERCP with serum amylase or lipase at least three times the upper limit of normal.

  Within 24 hours after ERCP

Secondary Outcomes (13)

• Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation

  Within 24 hours after ERCP

• Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation

  Within 24 hours after ERCP

• Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features

  Within 24 hours after ERCP

• Severity of Post-ERCP Pancreatitis

  Up to 30 days after ERCP

• Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis

  Within 24 hours after ERCP

Study Arms (2)

Rectal Indomethacin Alone

ACTIVE COMPARATOR

Participants will receive rectal indomethacin 100 mg administered peri-procedurally according to standard institutional practice. No post-procedural papillary ice water irrigation will be performed.

Drug: Rectal Indomethacin

Rectal Indomethacin Plus Papillary Ice Water Irrigation

EXPERIMENTAL

Participants will receive rectal indomethacin 100 mg administered peri-procedurally. Immediately after completion of ERCP, while the participant remains sedated and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization.

Drug: Rectal Indomethacin; Procedure: Papillary Ice Water Irrigation

Interventions

Rectal Indomethacin DRUG

Rectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.

Also known as: Indomethacin

Rectal Indomethacin Alone; Rectal Indomethacin Plus Papillary Ice Water Irrigation

Papillary Ice Water Irrigation PROCEDURE

Immediately after completion of ERCP and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots through the endoscope working channel under direct endoscopic visualization. The intervention is expected to add approximately 2 minutes to the procedure.

Rectal Indomethacin Plus Papillary Ice Water Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Undergoing ERCP with a native papilla.
• Eligible to receive rectal indomethacin.
• Able to provide informed consent.
• Willing and able to complete the required follow-up and post-procedure bloodwork.

You may not qualify if:

• Known allergy, hypersensitivity, or contraindication to indomethacin or rectal NSAIDs.
• Active acute pancreatitis at the time of ERCP.
• Prior sphincterotomy or absent native papilla.
• Prediction of papilla inaccessibility.
• Pregnancy.
• Inability or unwillingness to provide informed consent.
• Any clinical circumstance in which the treating endoscopist judges study participation to be unsafe or inappropriate.
• Chronic pancreatitis.
• Pancreatic head malignancy with complete main pancreatic duct obstruction.
• Altered luminal anatomy, other than Billroth I.

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will remain blinded to treatment allocation. Data analysts will also remain blinded. The endoscopist performing the ERCP cannot be blinded because they must either perform or omit post-procedural papillary ice water irrigation. Procedural documentation available to blinded outcome assessors will use neutral or standardized language where feasible to minimize inadvertent unblinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm, parallel-group superiority trial with participants randomized in a 1:1 ratio to rectal indomethacin alone or rectal indomethacin plus post-procedural papillary ice water irrigation.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share