3°C Saline Injection at the Duodenal Papilla to Prevent Post-ERCP Pancreatitis

NCT07381478 | Completed Phase 2 DMC

• 1 other identifier: Act 25 august 2025
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to diagnose and treat problems in the bile ducts and pancreas. One of its most common complications is \*\*post-ERCP pancreatitis\*\*. This multicenter randomized clinical trial will evaluate whether \*\*cooling the duodenal papilla\*\* with \*\*sterile saline at 3°C\*\* immediately after ERCP can reduce the risk of post-ERCP pancreatitis compared with standard ERCP care. Adults \*\*≥18 years\*\* with a \*\*native papilla\*\* scheduled for diagnostic or therapeutic ERCP at \*\*three high-complexity university hospitals in Bogotá/Cundinamarca (Colombia)\*\* will be randomized \*\*1:1\*\* to: (1) \*\*intervention\*\*-instillation of \*\*250 mL\*\* of \*\*3°C sterile saline\*\* in \*\*five 50-mL aliquots\*\* directed to the papilla through the endoscope working channel at the end of ERCP, with aspiration between aliquots; or (2) \*\*control\*\*-standard ERCP with no additional instillation. The saline temperature will be verified immediately before administration. Standard preventive measures (e.g., rectal NSAIDs, lactated Ringer's hydration, prophylactic pancreatic stent when clinically indicated) may be used per usual care and will be recorded. The \*\*primary outcome\*\* is post-ERCP pancreatitis at \*\*24 hours\*\*, defined using Cotton criteria (new/worsening abdominal pain plus serum amylase or lipase ≥3× the upper limit of normal). Secondary outcomes include pancreatitis severity, other ERCP-related complications, and safety through day 7 (including a telephone follow-up). Participants will be screened and consented before sedation; randomization occurs at the end of the ERCP; clinical assessment and labs are performed at 24 hours; follow-up continues through day 7. Safety monitoring will include systematic assessment for potential effects related to local cooling (e.g., chills, duodenal spasm, mucosal bleeding at the instillation site, or clinically relevant hypothermia) at 2 and 24 hours, with surveillance for serious adverse events through day 7.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of post-ERCP pancreatitis (PEP) at 24 hours

  Proportion of participants with PEP defined by Cotton criteria: compatible abdominal pain plus serum amylase or lipase ≥3× upper limit of normal at 24 hours

  24 hours after ERCP

Secondary Outcomes (2)

• Incidence of moderate-to-severe post-ERCP pancreatitis

  Up to Day 7 after ERCP

• Abdominal pain assessment

  24 hours after ERCP

Study Arms (2)

Cold Saline Papillary Irrigation (3°C)

EXPERIMENTAL

At the end of ERCP, 250 mL of sterile saline at 3°C is instilled onto the duodenal papilla in five 50-mL aliquots through the endoscope working channel, with aspiration between aliquots to enhance the local effect.

Procedure: Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C)

Standard ERCP (Usual Care)

ACTIVE COMPARATOR

Standard ERCP performed with no additional saline instillation. Usual prophylaxis may be used when clinically indicated (e.g., rectal NSAIDs, lactated Ringer's hydration, prophylactic pancreatic stent in high-risk cases) and is recorded.

Other: Standard ERCP (Usual Care)

Interventions

Standard ERCP (Usual Care) OTHER

Standard ERCP performed with no additional saline instillation. Usual prophylaxis may be used when clinically indicated (e.g., rectal NSAIDs, lactated Ringer's hydration, prophylactic pancreatic stent in high-risk cases) and is recorded.

Standard ERCP (Usual Care)

Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C) PROCEDURE

250 mL of 3°C sterile saline administered in five 50-mL aliquots directed to the papilla via the endoscope working channel at ERCP completion, with aspiration between aliquots; saline temperature is verified immediately before administration

Cold Saline Papillary Irrigation (3°C)

Eligibility Criteria

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

You may qualify if:

• Adults \*\*18 years of age or older\*\*
• \*\*Native (unmodified) duodenal papilla\*\*
• Scheduled for \*\*diagnostic or therapeutic ERCP\*\*

You may not qualify if:

• \*\*Inaccessible papilla\*\* or papilla \*\*surgically altered/modified\*\*
• \*\*Ongoing acute or chronic pancreatitis\*\*
• \*\*Pregnancy\*\*
• \*\*Ethical or medical contraindications to ERCP\*\*
• \*\*Lack of informed consent\*\*

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• Hospital San Rafael de Facatativá: collaborator

Study Sites (1)

Hospital San Rafael de Facatativá

Bogotá, Bogota D.C., 110111, Colombia

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research institute investigator

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: August 26, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 14, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CO (1)