Prophylaxis of Post-ERCP Acute Pancreatitis

NCT05381428 | Completed Phase 3 DMC

• 1 other identifier: RCT-PRO-PEP-INDO-RING
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 10

Brief Summary

This study aims to compare indomethacin and the combination of indomethacin and aggressive lactated Ringer infusion in terms of efficacy in preventing post-ERCP acute pancreatitis (PEP).

Conditions

Pancreatitis, Acute

Outcome Measures

Primary Outcomes (1)

• Incidence of PEP

  Onset of acute post-ERCP pancreatitis (PEP) at 24 hours after the procedure according to Cotton's criteria \[Mild, Moderate, Severe\]

  Assessed 24 hours after procedure

Secondary Outcomes (4)

• Severity of PEP

  Assessed 72 hours after the onset of acute pancreatitis

• Increased amylase and lipase

  Assessed 24 hours from baseline

• Onset of any adverse events

  Assessed postoperative bleeding within 30 days of surgery; increased plasma creatinine at 24 hours post-procedure; pulmonary oedema at 2, 8 and 24 hours after the procedure; water overload at 2, 8 and 24 hours after the procedure;

• Duration of Hospitalisation

  Assessed average length of stay up to 30 days

Study Arms (2)

Indomethacin Group (Control Arm)

ACTIVE COMPARATOR

Patients will be randomized to receive a 100 mg indomethacin suppository will be administered immediately before the endoscopic procedure (20-30 minutes) and saline infusion will be given as needed.

Drug: Indomethacin suppository

Indomethacin and Lactated Ringer Group (Intervention Arm)

EXPERIMENTAL

Patients will be randomized to receive an indomethacin suppository that will be administered immediately before (20-30 minutes) the endoscopic procedure in combination with a lactated Ringer's infusion that will be administered with the following weight-based schedule: 3 cc/kg/h during ERCP, a bolus of 20 cc/kg after ERCP, and again 3 cc/kg/h for 8 hours after ERCP.

Combination Product: Indomethacin suppository and high-flow lactated ringer infusion combination

Interventions

Indomethacin suppository DRUG

Control Group: Patients will be randomized to receive a 100 mg indomethacin suppository will be administered immediately before the endoscopic procedure (20-30 minutes) and saline infusion will be given as needed.

Indomethacin Group (Control Arm)

Indomethacin suppository and high-flow lactated ringer infusion combination COMBINATION_PRODUCT

Interventional group: Patients will be randomized to receive an indomethacin suppository that will be administered immediately before (20-30 minutes) the endoscopic procedure in combination with a lactated Ringer's infusion that will be administered with the following weight-based schedule: 3 cc/kg/h during ERCP, a bolus of 20 cc/kg after ERCP, and again 3 cc/kg/h for 8 hours after ERCP.

Indomethacin and Lactated Ringer Group (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• All naïve patients consecutively undergoing ERCP and with any indication;
• Obtaining informed consent.

You may not qualify if:

• Refusal or inability to sign informed consent;
• Patients undergoing ERCP for diagnostic purposes only;
• Patients with ongoing acute pancreatitis;
• Patients with known allergy/hypersensitivity to NSAIDs;
• Patients with hypersensitivity to the active ingredients or any of the excipients of Ringer
• Lactate;
• Patients with a personal or family history of Stevens-Johnson or Lyell syndrome;
• Patients already receiving treatment with NSAIDs within 7 days prior to ERCP;
• Patients with recent gastrointestinal bleeding (less than 30 days after ERCP), or with history of recurrent bleeding/ulcer peptic ulcer or bleeding/perforation after previous NSAID treatment;
• Patients who are candidates for or have previously undergone endoscopic papillectomy;
• Patients with a positive history of recent myocardial infarction (less than 6 months after the procedure), heart failure, severe myocardial insufficiency (NYHA class \> II), respiratory failure with chronic need for oxygen therapy, known pulmonary hypertension;
• Patients with ventricular fibrillation;
• Patients with ongoing therapy with cardioactive glycosides;
• Patients with chronic renal failure (creatinine clearance values less than 40 ml/min);
• Cirrhotic patients in Child B and C class;

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (10)

Azienda Ospedaliero-Universitaria di Modena - Ospedale civile di Baggiovara

Baggiovara, Modena, 41126, Italy

Location

Azienda USL di Modena - Ospedale di Carpi

Carpi, Modena, 41121, Italy

Location

AUSL Bologna - Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, 40133, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale sant'Anna

Ferrara, 44124, Italy

Location

AUSL della Romagna - Ospedale Morgagni-Pierantoni di Forlì

Forlì, 47121, Italy

Location

Azienda Ospedaliero - Universitaria di Parma

Parma, 43100, Italy

Location

Ospedale Guglielmo da Saliceto - AUSL Piacenza

Piacenza, 29121, Italy

Location

AUSL Romagna - Ospedale Santa Maria delle Croci

Ravenna, 48100, Italy

Location

AUSL- IRCCS di Reggio Emilia

Reggio Emilia, 42122, Italy

Location

AUSL della Romagna - Ospedale Infermi di Rimini

Rimini, 47920, Italy

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Romano Sassatelli

  AUSL-IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: May 13, 2022
• Primary Completion: October 12, 2024
• Study Completion: October 12, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)