Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

NCT07738094 | Recruiting

• 1 other identifier: 97150326.3.0000.0068
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief Summary

The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.

Conditions

Pancreatitis, Acute

Keywords

Post-ERCP Pancreatitis; Cryoprevention; ERCP; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-ERCP Pancreatitis (PEP).

  New or worsened abdominal pain consistent with pancreatitis, associated with an elevation of serum amylase or lipase at least 3 times the upper limit of normal

  Immediately after the procedure until 03 days after the procedure

Secondary Outcomes (5)

• PEP Severity

  Day 1 (24 hours post-procedure) and 7 days post-procedure

• Cholangitis

  Day 1 (24 hours post-procedure) and 7 days post-procedure

• Bleeding

  Day 1 (24 hours post-procedure) and 7 days post-procedure

• Perforation

  Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure)

• Mortality

  Up to 90 days post-procedure

Study Arms (2)

NSAID alone

ACTIVE COMPARATOR

Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.

Procedure: NSAID alone

Cryoprevention associated with NSAID

EXPERIMENTAL

Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).

Procedure: Cryoprevention associated with NSAID

Interventions

NSAID alone PROCEDURE

Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.

NSAID alone

Cryoprevention associated with NSAID PROCEDURE

Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).

Cryoprevention associated with NSAID

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older
• Clinical indication for ERCP
• Presence of native major duodenal papilla without previous manipulation
• Ability of the patient or companion to provide informed consent.

You may not qualify if:

• Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)
• Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)
• Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)
• Pregnant women
• Refusal to participate in the study or inability to sign the ICF
• Contraindication to NSAID use.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (12)

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• Janssens LP, Yamparala A, Martin J, O'Meara J, Harmsen WS, Sathi T, Lemke E, Abu Dayyeh BK, Bofill-Garcia A, Petersen BT, Storm AC, Topazian M, Vargas EJ, Chandrasekhara V, Law RJ. Incidence of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin vs. Compounded Rectal Diclofenac Prophylaxis. Dig Dis Sci. 2024 Oct;69(10):3970-3978. doi: 10.1007/s10620-024-08604-5. Epub 2024 Aug 31.

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• 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: 40638082 BACKGROUND

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  PMID: 34977992 BACKGROUND

• Lee H, Natsui H, Akimoto T, Yanagi K, Ohshima N, Kono I. Effects of cryotherapy after contusion using real-time intravital microscopy. Med Sci Sports Exerc. 2005 Jul;37(7):1093-8. doi: 10.1249/01.mss.0000169611.21671.2e.

  PMID: 16015124 BACKGROUND

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  PMID: 14608432 BACKGROUND

• ASGE STANDARDS OF PRACTICE COMMITTEE; Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Chowdhury A, Coelho-Prabhu N, Das R, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sadik J, Sheth SG, Thiruvengadam NR, Thosani NC, Zhou S, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: methodology and review of evidence. Gastrointest Endosc. 2023 Feb;97(2):163-183.e40. doi: 10.1016/j.gie.2022.09.011. Epub 2022 Dec 12. No abstract available.

  PMID: 36517309 BACKGROUND

• 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.

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  PMID: 25088919 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Fauze Maluf Filho

  Hospital das Clínicas da Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. Fauze Maluf Filho

CONTACT

+55 11 99191-9014; fauze.maluf@terra.com.br

Dr. Mateus Bond Boghossian

CONTACT

+55 11 91795-4571; matbogho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Neither the patients nor the researchers responsible for data extraction and statistical analysis will know which group the patients are assigned to. However, the physicians performing the procedure will not be blinded, as the endoscopist will be operating the device and will therefore be aware of whether or not ice-cold water was used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Endoscopy Unit at the São Paulo Cancer Institute (ICESP) and HCFMUSP

Model Details: Parallel Assignment (Randomized 1:1 paired clinical trial)

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 30, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)