An interventional study of Cold water irrigation of the papilla and Rectal NSAID (diclofenac 100 mg) in Post ERCP Pancreatitis and Acute Pancreatitis (AP), sponsored by University Hospital Virgen de las Nieves. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University Hospital Virgen de las Nieves · Not applicable, Interventional, and Prevention
Post-ERCP pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal non-steroidal anti-inflammatory drugs (NSAIDs) are the current standard prophylaxis. Recent studies suggest that irrigating the papilla with cold water after biliary sphincterotomy may reduce the risk of pancreatitis, but this has not been tested in combination with rectal NSAIDs.
This pilot randomized trial compares rectal NSAIDs plus cold water irrigation of the papilla with rectal NSAIDs alone in adults undergoing ERCP with sphincterotomy. Patients are unaware of their group. The main outcome is the incidence of post-ERCP pancreatitis. Results will be used to estimate event rates and calculate the sample size of a future confirmatory trial.
Unlike previous trials, prophylaxis consists of rectal diclofenac without aggressive intravenous hydration, reflecting standard European practice.
Single-center, prospective, randomized (1:1, block randomization with centralized concealed allocation), patient-blinded pilot trial at Hospital Universitario Virgen de las Nieves, Granada, Spain.
All patients receive standard rectal NSAID prophylaxis before ERCP. Patients randomized to the experimental arm receive, as the final step of the procedure, irrigation of the papilla with 250 mL of ice-cold water delivered in five 50-mL aliquots through the working channel of the duodenoscope; the first four aliquots are aspirated and the last is left in place.
Post-ERCP pancreatitis is defined by Cotton criteria (typical abdominal pain and serum amylase or lipase >3 times the upper limit of normal within the first 24 hours). Severity is graded according to the revised Atlanta classification. Patients are followed during hospitalization, with clinical assessments after ERCP and on day 1 and laboratory tests within 24 hours. Adverse events are recorded up to 7 days after the procedure.
All patients receive rectal diclofenac 100 mg before ERCP. Aggressive intravenous hydration is not part of the protocol; its use, if clinically indicated, is recorded. Both the patient and the investigator who assesses the outcome are blinded to treatment allocation.
759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 450 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →University Hospital Virgen de las Nieves is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Rectal NSAID before ERCP plus cold water irrigation of the papilla after sphincterotomy
Procedure: Cold water irrigation of the papilla · Drug: Rectal NSAID (diclofenac 100 mg)
Rectal NSAID before ERCP (standard prophylaxis)
Drug: Rectal NSAID (diclofenac 100 mg)
250 mL of ice-cold water (5 × 50 mL) instilled through the duodenoscope working channel after sphincterotomy; the first four aliquots are aspirated
Standard pre-procedural prophylaxis administered to all patients
Incidence of post-ERCP pancreatitis (Cotton criteria)
Clinical and analytical pancreatitis within 24 hours after inclusion in the study.
Time frame: Day 1
Severity of post-ERCP pancreatitis (revised Atlanta classification)
In cases with acute pancreatitis, adequate grading of severity is performed 14 days after inclusion in the study, which is the minimum time frame for a complete Atlanta Classification.
Time frame: Up to 14 days
Incidence of post-ERCP pancreatitis in patients with difficult cannulation and with pancreatic duct cannulation
Clinical and analytical pancreatitis within 24 hours after inclusion in the study, in cases with difficult cannulation.
Time frame: Day 1
Incidence of post-ERCP pancreatitis according to use of aggressive hydration or pancreatic stent
Clinical and analytical pancreatitis within 24 hours after inclusion in the study, in cases with additional preventive measures.
Time frame: Day 1
Adverse events (bleeding, perforation, cholangitis, other)
Occurrence of other ERCP adverse events.
Time frame: Up to 7 days
Length of hospital stay
Days admitted from the inclusion in the study to hospital discharge.
Time frame: Up to 30 days
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publications (diagnostic findings of each modality, histology and baseline characteristics) will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signature of a data sharing agreement. Sharing will comply with the General Data Protection Regulation and Spanish Organic Law 3/2018 and may require approval by the Research Ethics Committee of Granada.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the main results and for 5 years thereafter.
Access criteria: Researchers submitting a methodologically sound proposal approved by the study investigators; a signed data sharing agreement is required.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Hospital Virgen de las Nieves