NCT07885852

Brief Summary

Post-ERCP pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal non-steroidal anti-inflammatory drugs (NSAIDs) are the current standard prophylaxis. Recent studies suggest that irrigating the papilla with cold water after biliary sphincterotomy may reduce the risk of pancreatitis, but this has not been tested in combination with rectal NSAIDs. This pilot randomized trial compares rectal NSAIDs plus cold water irrigation of the papilla with rectal NSAIDs alone in adults undergoing ERCP with sphincterotomy. Patients are unaware of their group. The main outcome is the incidence of post-ERCP pancreatitis. Results will be used to estimate event rates and calculate the sample size of a future confirmatory trial. Unlike previous trials, prophylaxis consists of rectal diclofenac without aggressive intravenous hydration, reflecting standard European practice.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1.2 years

First QC Date

October 7, 2026

Last Update Submit

October 13, 2026

Conditions

Post ERCP PancreatitisAcute Pancreatitis (AP)

Keywords

cold watercryopreventionrectan NSAIDDiclofenac

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-ERCP pancreatitis (Cotton criteria)

    Clinical and analytical pancreatitis within 24 hours after inclusion in the study.

    Day 1

Secondary Outcomes (5)

  • Severity of post-ERCP pancreatitis (revised Atlanta classification)

    Up to 14 days

  • Incidence of post-ERCP pancreatitis in patients with difficult cannulation and with pancreatic duct cannulation

    Day 1

  • Incidence of post-ERCP pancreatitis according to use of aggressive hydration or pancreatic stent

    Day 1

  • Adverse events (bleeding, perforation, cholangitis, other)

    Up to 7 days

  • Length of hospital stay

    Up to 30 days

Study Arms (2)

Cold water + rectal NSAIDs

EXPERIMENTAL

Rectal NSAID before ERCP plus cold water irrigation of the papilla after sphincterotomy

Procedure: Cold water irrigation of the papillaDrug: Rectal NSAID (diclofenac 100 mg)

Rectal NSAIDs alone

ACTIVE COMPARATOR

Rectal NSAID before ERCP (standard prophylaxis)

Drug: Rectal NSAID (diclofenac 100 mg)

Interventions

Cold water irrigation of the papillaPROCEDURE

250 mL of ice-cold water (5 Ă— 50 mL) instilled through the duodenoscope working channel after sphincterotomy; the first four aliquots are aspirated

Cold water + rectal NSAIDs
Rectal NSAID (diclofenac 100 mg)DRUG

Standard pre-procedural prophylaxis administered to all patients

Cold water + rectal NSAIDsRectal NSAIDs alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • ERCP in a patient with a native papilla.
  • Biliary sphincterotomy performed during the procedure.
  • Rectal NSAID prophylaxis administered.
  • Signed informed consent.

You may not qualify if:

  • Non-native papilla or surgically altered biliary anatomy (except liver transplant recipients).
  • Allergy or hypersensitivity to NSAIDs.
  • Acute or chronic pancreatitis.
  • Cancer of the pancreatic head.
  • Refusal to participate or to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals

Granada, Granada, 18014, Spain

Location

Related Publications (8)

  • de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.

    PMID: 36103415BACKGROUND

  • Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

    PMID: 2070995BACKGROUND

  • Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13.

    PMID: 29237204BACKGROUND

  • Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.

    PMID: 38219767BACKGROUND

  • Mukai S, Takeyama Y, Itoi T, Ikeura T, Irisawa A, Iwasaki E, Katanuma A, Kitamura K, Takenaka M, Hirota M, Mayumi T, Morizane T, Yasuda I, Ryozawa S, Masamune A. Clinical Practice Guidelines for post-ERCP pancreatitis 2023. Dig Endosc. 2025 Jun;37(6):573-587. doi: 10.1111/den.15004. Epub 2025 Mar 25.

    PMID: 40132896BACKGROUND

  • Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

    PMID: 31863440BACKGROUND

  • Azuma S, Kurita A, Katayama T, Iwano K, Iimori K, Kawai Y, Sawada K, Yazumi S. Cooling the papilla with ice water in preventing post-ERCP pancreatitis (ice water challenge study). Surg Endosc. 2022 Aug;36(8):6002-6006. doi: 10.1007/s00464-021-08924-x. Epub 2022 Jan 3.

    PMID: 34977992BACKGROUND

  • Azuma S, Kobayashi Y, Harada R, Yane K, Sawada K, Tsujimoto A, Inatomi O, Matsumori T, Yoshimura K, Yazumi S, Kurita A. Local Postprocedural Cryoprevention Significantly Reduces the Incidence of Post-ERCP Pancreatitis: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2025 Jul 10. doi: 10.14309/ajg.0000000000003644. Online ahead of print.

    PMID: 40638082BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Eduardo Redondo-Cerezo, MD, PhD

CONTACT

+34 657373336eredondoc@gmail.com

Juan G Martinez-Cara, MD

CONTACT

+34 630863340juangadoctor@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Gastroenterology Department. Hospital Universitario Virgen de las Nieves.

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 21, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the publications (diagnostic findings of each modality, histology and baseline characteristics) will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signature of a data sharing agreement. Sharing will comply with the General Data Protection Regulation and Spanish Organic Law 3/2018 and may require approval by the Research Ethics Committee of Granada.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months after publication of the main results and for 5 years thereafter.
Access Criteria
Researchers submitting a methodologically sound proposal approved by the study investigators; a signed data sharing agreement is required.

Locations

ES(1)