PancreatitisPhase 2/3NCT07381478
3°C Saline Injection at the Duodenal Papilla to Prevent Post-ERCP Pancreatitis
A Phase 2/3 study testing Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C) in people with Pancreatitis, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteColombia
- Study dates
- 26 Aug 2025to 14 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- Native (unmodified) duodenal papilla
- Scheduled for diagnostic or therapeutic ERCP
Who cannot join
- Inaccessible papilla or papilla surgically altered/modified
- Ongoing acute or chronic pancreatitis
- Pregnancy
- Ethical or medical contraindications to ERCP
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C), Standard ERCP (Usual Care)
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C)Procedure or surgery
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard ERCP (Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after ERCP
Secondary outcomes (2)
Incidence of moderate-to-severe post-ERCP pancreatitis
Measured: Up to Day 7 after ERCP
Abdominal pain assessment
Measured: 24 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start26 Aug 2025
- Primary completion12 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Rafael de Facatativá
- Responsible party
- Principal investigator, Juan Pablo Alzate, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381478
- Sponsor's protocol ID
- Act 25 august 2025
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07381478
- Acronym / sponsor ID
- Act 25 august 2025
- Conditions
- Pancreatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- Hospital San Rafael de Facatativá
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Saline Papillary Irrigation (3°C) | Experimental | Procedure: Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (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. |
| Standard ERCP (Usual Care) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age or older
- Native (unmodified) duodenal papilla
- Scheduled for diagnostic or therapeutic ERCP
Key exclusion criteria (5 listed)
- Inaccessible papilla or papilla surgically altered/modified
- Ongoing acute or chronic pancreatitis
- Pregnancy
- Ethical or medical contraindications to ERCP
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Cold Saline Papillary Irrigation (3°C) |
| 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) |
Primary outcome
Incidence of post-ERCP pancreatitis (PEP) at 24 hours
Time frame: 24 hours after ERCP
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C) in people with Pancreatitis, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-ERCP pancreatitis (PEP) at 24 hours (time frame: 24 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.