Pancreatitis
Conditions
Keywords
Post-ERCP pancreatitis, Endoscopic retrograde cholangiopancreatography, Rectal indomethacin, Papillary cryoprevention
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.
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.
Interventions
Rectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.
PROCEDUREPapillary Ice Water Irrigation
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.
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation | Within 24 hours after ERCP | Incidence of post-ERCP pancreatitis among participants meeting the protocol-defined criteria for difficult cannulation. |
| Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation | Within 24 hours after ERCP | Incidence of post-ERCP pancreatitis among participants in whom the pancreatic duct is cannulated during ERCP. |
| Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features | Within 24 hours after ERCP | Incidence of post-ERCP pancreatitis among participants with protocol-defined high-risk features for PEP. |
| Severity of Post-ERCP Pancreatitis | Up to 30 days after ERCP | Severity will be classified according to the Revised Atlanta Classification as mild, moderately severe, or severe acute pancreatitis. |
| Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis | Within 24 hours after ERCP | Proportion of participants with elevated serum amylase and/or lipase after ERCP without meeting criteria for post-ERCP pancreatitis. |
| Bleeding | Up to 30 days after ERCP | Incidence of ERCP-related bleeding. |
| Cholangitis | Up to 30 days after ERCP | Incidence of cholangitis following ERCP. |
| Perforation | Up to 30 days after ERCP | Incidence of ERCP-related perforation. |
| Mortality | Up to 30 days after ERCP | All-cause mortality during study follow-up. |
| ICU Admission | Up to 30 days after ERCP | Proportion of participants requiring admission to an intensive care unit. |
| Hospital Admission or Prolonged Hospitalization | Up to 30 days after ERCP | Proportion of participants requiring hospital admission or prolonged hospitalization following ERCP. |
| Need for Rescue Interventions | Up to 30 days after ERCP | Proportion of participants requiring additional rescue interventions for an ERCP-related complication. |
| 30-Day Readmission | Within 30 days after ERCP | Proportion of participants readmitted to hospital within 30 days following ERCP. |
Outcome results
None listed