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NCT Number: NCT07826026

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

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.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The N-ICE Trial is a prospective, randomized, patient- and assessor-blinded, parallel-group superiority trial evaluating whether post-procedural papillary ice water irrigation provides additional protection against post-ERCP pancreatitis (PEP) when added to standard rectal indomethacin prophylaxis.

Eligible adults undergoing ERCP with a native papilla will be randomized in a 1:1 ratio to receive either rectal indomethacin 100 mg alone or rectal indomethacin 100 mg plus post-procedural papillary ice water irrigation. In the intervention group, immediately following 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 under direct endoscopic visualization. The endoscopist cannot be blinded to treatment assignment; participants and outcome assessors will remain blinded.

The primary objective is to determine whether adding papillary ice water irrigation to rectal indomethacin reduces the incidence of PEP. Participants will undergo clinical and biochemical assessment following ERCP, including measurement of serum amylase and/or lipase within 24 hours, with subsequent follow-up for delayed adverse events and health care utilization through 30 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Rectal Indomethacin

Drug

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

Other names: Indomethacin

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.

Primary outcomes

  1. Incidence of Post-ERCP Pancreatitis

    Time frame: Within 24 hours after ERCP

    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.

Secondary outcomes

  1. Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation

    Time frame: Within 24 hours after ERCP

    Incidence of post-ERCP pancreatitis among participants meeting the protocol-defined criteria for difficult cannulation.

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

    Time frame: Within 24 hours after ERCP

    Incidence of post-ERCP pancreatitis among participants in whom the pancreatic duct is cannulated during ERCP.

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

    Time frame: Within 24 hours after ERCP

    Incidence of post-ERCP pancreatitis among participants with protocol-defined high-risk features for PEP.

  4. Severity of Post-ERCP Pancreatitis

    Time frame: Up to 30 days after ERCP

    Severity will be classified according to the Revised Atlanta Classification as mild, moderately severe, or severe acute pancreatitis.

  5. Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis

    Time frame: Within 24 hours after ERCP

    Proportion of participants with elevated serum amylase and/or lipase after ERCP without meeting criteria for post-ERCP pancreatitis.

  6. Bleeding

    Time frame: Up to 30 days after ERCP

    Incidence of ERCP-related bleeding.

  7. Cholangitis

    Time frame: Up to 30 days after ERCP

    Incidence of cholangitis following ERCP.

  8. Perforation

    Time frame: Up to 30 days after ERCP

    Incidence of ERCP-related perforation.

  9. Mortality

    Time frame: Up to 30 days after ERCP

    All-cause mortality during study follow-up.

  10. ICU Admission

    Time frame: Up to 30 days after ERCP

    Proportion of participants requiring admission to an intensive care unit.

  11. Hospital Admission or Prolonged Hospitalization

    Time frame: Up to 30 days after ERCP

    Proportion of participants requiring hospital admission or prolonged hospitalization following ERCP.

  12. Need for Rescue Interventions

    Time frame: Up to 30 days after ERCP

    Proportion of participants requiring additional rescue interventions for an ERCP-related complication.

  13. 30-Day Readmission

    Time frame: Within 30 days after ERCP

    Proportion of participants readmitted to hospital within 30 days following ERCP.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Rectal Indomethacin Alone Versus Rectal Indomethacin Plus Post-procedural Papillary Ice Water Irrigation for Prevention of Post-ERCP Pancreatitis (N-ICE Trial): A Randomized, Patient- and Assessor-Blinded, Superiority Multicenter Trial

Acronym: N-ICE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 17, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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