Pancreatitis
Conditions
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.
Interventions
PROCEDURETopical 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
OTHERStandard 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.
Sponsors
Universidad Nacional de Colombia
Hospital San Rafael de Facatativá
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*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\*\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ERCP pancreatitis (PEP) at 24 hours | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of moderate-to-severe post-ERCP pancreatitis | Up to Day 7 after ERCP |
| Abdominal pain assessment | 24 hours after ERCP |
Countries
Colombia
Outcome results
None listed