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

Sponsor
Unity Health Toronto
Study ID
NCT07826026
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Oct 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Rectal Indomethacin Alone
    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.
  • Experimental: Rectal Indomethacin Plus Papillary Ice Water Irrigation
    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.

Primary Outcome Measure

Incidence of Post-ERCP Pancreatitis [ Time Frame: Within 24 hours after ERCP ]

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