An interventional study of Rectal Indomethacin and Papillary Ice Water Irrigation in Pancreatitis, sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Prevention
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.
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Rectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.
Also known as: Indomethacin
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.
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.
Time frame: Within 24 hours after ERCP
Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation
Incidence of post-ERCP pancreatitis among participants meeting the protocol-defined criteria for difficult cannulation.
Time frame: Within 24 hours after ERCP
Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation
Incidence of post-ERCP pancreatitis among participants in whom the pancreatic duct is cannulated during ERCP.
Time frame: Within 24 hours after ERCP
Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features
Incidence of post-ERCP pancreatitis among participants with protocol-defined high-risk features for PEP.
Time frame: Within 24 hours after ERCP
Severity of Post-ERCP Pancreatitis
Severity will be classified according to the Revised Atlanta Classification as mild, moderately severe, or severe acute pancreatitis.
Time frame: Up to 30 days after ERCP
Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis
Proportion of participants with elevated serum amylase and/or lipase after ERCP without meeting criteria for post-ERCP pancreatitis.
Time frame: Within 24 hours after ERCP
Bleeding
Incidence of ERCP-related bleeding.
Time frame: Up to 30 days after ERCP
Cholangitis
Incidence of cholangitis following ERCP.
Time frame: Up to 30 days after ERCP
Perforation
Incidence of ERCP-related perforation.
Time frame: Up to 30 days after ERCP
Mortality
All-cause mortality during study follow-up.
Time frame: Up to 30 days after ERCP
ICU Admission
Proportion of participants requiring admission to an intensive care unit.
Time frame: Up to 30 days after ERCP
Hospital Admission or Prolonged Hospitalization
Proportion of participants requiring hospital admission or prolonged hospitalization following ERCP.
Time frame: Up to 30 days after ERCP
Need for Rescue Interventions
Proportion of participants requiring additional rescue interventions for an ERCP-related complication.
Time frame: Up to 30 days after ERCP
30-Day Readmission
Proportion of participants readmitted to hospital within 30 days following ERCP.
Time frame: Within 30 days after ERCP
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.