PancreatitisN-ICENCT07826026
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
A study testing Rectal Indomethacin and Papillary Ice Water Irrigation in people with Pancreatitis, run by Unity Health Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Rectal Indomethacin and Papillary Ice Water Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Pancreatitis
- Being tested
- Rectal Indomethacin, Papillary Ice Water Irrigation
- Keywords
- Post-ERCP pancreatitis, Endoscopic retrograde cholangiopancreatography, Rectal indomethacin, Papillary cryoprevention
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal IndomethacinDrug
Also called Indomethacin
Rectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.
Papillary Ice Water IrrigationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Rectal Indomethacin; Procedure: Papillary Ice Water Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after ERCP
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24 hours after ERCP
Bleeding
Incidence of ERCP-related bleeding.
Measured: Up to 30 days after ERCP
Cholangitis
Incidence of cholangitis following ERCP.
Measured: Up to 30 days after ERCP
Perforation
Incidence of ERCP-related perforation.
Measured: Up to 30 days after ERCP
Mortality
All-cause mortality during study follow-up.
Measured: Up to 30 days after ERCP
ICU Admission
Proportion of participants requiring admission to an intensive care unit.
Measured: Up to 30 days after ERCP
Hospital Admission or Prolonged Hospitalization
Proportion of participants requiring hospital admission or prolonged hospitalization following ERCP.
Measured: Up to 30 days after ERCP
Need for Rescue Interventions
Proportion of participants requiring additional rescue interventions for an ERCP-related complication.
Measured: Up to 30 days after ERCP
30-Day Readmission
Proportion of participants readmitted to hospital within 30 days following ERCP.
Measured: Within 30 days after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Gupta, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826026
- Sponsor's protocol ID
- N-ICE
- Acronym
- N-ICE
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07826026
- Acronym / sponsor ID
- N-ICE / N-ICE
- Conditions
- Pancreatitis
- Keywords
- Post-ERCP pancreatitis, Endoscopic retrograde cholangiopancreatography, Rectal indomethacin, Papillary cryoprevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rectal Indomethacin Alone | Active comparator | Drug: Rectal IndomethacinParticipants will receive rectal indomethacin 100 mg administered peri-procedurally according to standard institutional practice. No post-procedural papillary ice water irrigation will be performed. |
| Rectal Indomethacin Plus Papillary Ice Water Irrigation | Experimental | Drug: Rectal Indomethacin, Procedure: Papillary Ice Water IrrigationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal IndomethacinAlso: IndomethacinRectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice. | Drug | Rectal Indomethacin Alone, Rectal Indomethacin Plus Papillary Ice Water Irrigation |
| Papillary Ice Water IrrigationImmediately 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. | Procedure or surgery | Rectal Indomethacin Plus Papillary Ice Water Irrigation |
Primary outcome
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.
13 secondary outcomes
Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation
Time frame: Within 24 hours after ERCP
Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation
Time frame: Within 24 hours after ERCP
Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features
Time frame: Within 24 hours after ERCP
Severity of Post-ERCP Pancreatitis
Time frame: Up to 30 days after ERCP
Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis
Time frame: Within 24 hours after ERCP
Bleeding
Time frame: Up to 30 days after ERCP
Cholangitis
Time frame: Up to 30 days after ERCP
Perforation
Time frame: Up to 30 days after ERCP
Mortality
Time frame: Up to 30 days after ERCP
ICU Admission
Time frame: Up to 30 days after ERCP
Hospital Admission or Prolonged Hospitalization
Time frame: Up to 30 days after ERCP
Need for Rescue Interventions
Time frame: Up to 30 days after ERCP
30-Day Readmission
Time frame: Within 30 days after ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal Indomethacin and Papillary Ice Water Irrigation in people with Pancreatitis, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-ERCP Pancreatitis (time frame: Within 24 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.