A Phase 2/3 interventional study of Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C) and Standard ERCP (Usual Care) in Pancreatitis, sponsored by Universidad Nacional de Colombia. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Universidad Nacional de Colombia · Phase 2/3, Interventional, and Treatment
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's enrollment of 900 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Universidad Nacional de Colombia is the lead sponsor of 39 studies on the registry; 6 are open to participants now.
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**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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)
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
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.
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
Time frame: 24 hours after ERCP
Incidence of moderate-to-severe post-ERCP pancreatitis
Time frame: Up to Day 7 after ERCP
Abdominal pain assessment
Time frame: 24 hours after ERCP
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2025 to primary completion in Jan 2026, 4 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Colombia