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

Effect of 3°C Saline Irrigation Toward the Duodenal Papilla to Prevent Post-ERCP Pancreatitis: Protocol for a Multicenter, Controlled, Randomized, Patient-Blinded Trial in Bogotá, Colombia.

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis
• Intervention / Treatment: Procedure: Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C); Other: Standard ERCP (Usual Care)

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110111
      • Hospital San Rafael de Facatativá

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

**Inclusion Criteria:**

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

**Exclusion Criteria:**

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold Saline Papillary Irrigation (3°C); 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); 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
Active Comparator: Standard ERCP (Usual Care); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Incidence of moderate-to-severe post-ERCP pancreatitis	Up to Day 7 after ERCP
Abdominal pain assessment	24 hours after ERCP

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Collaborators: Hospital San Rafael de Facatativá

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2025
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 14, 2026

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: Act 25 august 2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No