Post ERCP PancreatitisCOLDHUVNNCT07885852
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
A study testing Cold water irrigation of the papilla and Rectal NSAID (diclofenac 100 mg) in people with Post ERCP Pancreatitis and Acute Pancreatitis (AP), run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post ERCP Pancreatitis, Acute Pancreatitis (AP)
- What is being tested?
- Cold water irrigation of the papilla and Rectal NSAID (diclofenac 100 mg)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- ERCP in a patient with a native papilla.
- Biliary sphincterotomy performed during the procedure.
- Rectal NSAID prophylaxis administered.
- Signed informed consent.
Who cannot join
- Non-native papilla or surgically altered biliary anatomy (except liver transplant recipients).
- Allergy or hypersensitivity to NSAIDs.
- Acute or chronic pancreatitis.
- Cancer of the pancreatic head.
- Refusal to participate or to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals
Granada, Granada, 18014
Eduardo Redondo-Cerezo, MD, PhD, eredondoc@gmail.com
About this study
Official title: Prevention of Post-ERCP Pancreatitis With Cold Water Irrigation of the Papilla Added to Rectal NSAIDs Versus Rectal NSAIDs Alone: a Single-Center, Randomized, Single-Blind Pilot Trial
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.
Read the detailed description
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.
- Conditions
- Post ERCP Pancreatitis, Acute Pancreatitis (AP)
- Being tested
- Cold water irrigation of the papilla, Rectal NSAID (diclofenac 100 mg)
- Keywords
- cold water, cryoprevention, rectan NSAID, Diclofenac
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water irrigation of the papillaProcedure or surgery
250 mL of ice-cold water (5 × 50 mL) instilled through the duodenoscope working channel after sphincterotomy; the first four aliquots are aspirated
Rectal NSAID (diclofenac 100 mg)Drug
Standard pre-procedural prophylaxis administered to all patients
| Study group | Role | What they receive |
|---|---|---|
| Cold water + rectal NSAIDs | Experimental | Rectal NSAID before ERCP plus cold water irrigation of the papilla after sphincterotomy Receives: Procedure: Cold water irrigation of the papilla; Drug: Rectal NSAID (diclofenac 100 mg) |
| Rectal NSAIDs alone | Active comparator | Rectal NSAID before ERCP (standard prophylaxis) Receives: Drug: Rectal NSAID (diclofenac 100 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-ERCP pancreatitis (Cotton criteria)
Clinical and analytical pancreatitis within 24 hours after inclusion in the study.
Measured: Day 1
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Adverse events (bleeding, perforation, cholangitis, other)
Occurrence of other ERCP adverse events.
Measured: Up to 7 days
Length of hospital stay
Days admitted from the inclusion in the study to hospital discharge.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post ERCP 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDUARDO REDONDO CEREZO, MD, PhD, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885852
- Sponsor's protocol ID
- COLD.HUVN.26
- Acronym
- COLDHUVN
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
PubMed 36103415Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
PubMed 2070995Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13.
PubMed 29237204Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.
PubMed 38219767Mukai S, Takeyama Y, Itoi T, Ikeura T, Irisawa A, Iwasaki E, Katanuma A, Kitamura K, Takenaka M, Hirota M, Mayumi T, Morizane T, Yasuda I, Ryozawa S, Masamune A. Clinical Practice Guidelines for post-ERCP pancreatitis 2023. Dig Endosc. 2025 Jun;37(6):573-587. doi: 10.1111/den.15004. Epub 2025 Mar 25.
PubMed 40132896Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Azuma S, Kurita A, Katayama T, Iwano K, Iimori K, Kawai Y, Sawada K, Yazumi S. Cooling the papilla with ice water in preventing post-ERCP pancreatitis (ice water challenge study). Surg Endosc. 2022 Aug;36(8):6002-6006. doi: 10.1007/s00464-021-08924-x. Epub 2022 Jan 3.
PubMed 34977992Azuma S, Kobayashi Y, Harada R, Yane K, Sawada K, Tsujimoto A, Inatomi O, Matsumori T, Yoshimura K, Yazumi S, Kurita A. Local Postprocedural Cryoprevention Significantly Reduces the Incidence of Post-ERCP Pancreatitis: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2025 Jul 10. doi: 10.14309/ajg.0000000000003644. Online ahead of print.
PubMed 40638082
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-ERCP Pancreatitis With Cold Water Irrigation of the Papilla Added to Rectal NSAIDs Versus Rectal NSAIDs Alone: a Single-Center, Randomized, Single-Blind Pilot Trial
- ClinicalTrials.gov ID
- NCT07885852
- Acronym / sponsor ID
- COLDHUVN / COLD.HUVN.26
- Conditions
- Post ERCP Pancreatitis, Acute Pancreatitis (AP)
- Keywords
- cold water, cryoprevention, rectan NSAID, Diclofenac
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Cold water + rectal NSAIDs | Experimental | Procedure: Cold water irrigation of the papilla, Drug: Rectal NSAID (diclofenac 100 mg)Rectal NSAID before ERCP plus cold water irrigation of the papilla after sphincterotomy |
| Rectal NSAIDs alone | Active comparator | Drug: Rectal NSAID (diclofenac 100 mg)Rectal NSAID before ERCP (standard prophylaxis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- ERCP in a patient with a native papilla.
- Biliary sphincterotomy performed during the procedure.
- Rectal NSAID prophylaxis administered.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Non-native papilla or surgically altered biliary anatomy (except liver transplant recipients).
- Allergy or hypersensitivity to NSAIDs.
- Acute or chronic pancreatitis.
- Cancer of the pancreatic head.
- Refusal to participate or to sign 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 |
|---|---|---|
| Cold water irrigation of the papilla250 mL of ice-cold water (5 × 50 mL) instilled through the duodenoscope working channel after sphincterotomy; the first four aliquots are aspirated | Procedure or surgery | Cold water + rectal NSAIDs |
| Rectal NSAID (diclofenac 100 mg)Standard pre-procedural prophylaxis administered to all patients | Drug | Cold water + rectal NSAIDs, Rectal NSAIDs alone |
Primary outcome
Incidence of post-ERCP pancreatitis (Cotton criteria)
Time frame: Day 1
Clinical and analytical pancreatitis within 24 hours after inclusion in the study.
5 secondary outcomes
Severity of post-ERCP pancreatitis (revised Atlanta classification)
Time frame: Up to 14 days
Incidence of post-ERCP pancreatitis in patients with difficult cannulation and with pancreatic duct cannulation
Time frame: Day 1
Incidence of post-ERCP pancreatitis according to use of aggressive hydration or pancreatic stent
Time frame: Day 1
Adverse events (bleeding, perforation, cholangitis, other)
Time frame: Up to 7 days
Length of hospital stay
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 36103415de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
- Background: PubMed 2070995Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Background: PubMed 29237204Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13.
- Background: PubMed 38219767Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.
- Background: PubMed 40132896Mukai S, Takeyama Y, Itoi T, Ikeura T, Irisawa A, Iwasaki E, Katanuma A, Kitamura K, Takenaka M, Hirota M, Mayumi T, Morizane T, Yasuda I, Ryozawa S, Masamune A. Clinical Practice Guidelines for post-ERCP pancreatitis 2023. Dig Endosc. 2025 Jun;37(6):573-587. doi: 10.1111/den.15004. Epub 2025 Mar 25.
- Background: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Background: PubMed 34977992Azuma S, Kurita A, Katayama T, Iwano K, Iimori K, Kawai Y, Sawada K, Yazumi S. Cooling the papilla with ice water in preventing post-ERCP pancreatitis (ice water challenge study). Surg Endosc. 2022 Aug;36(8):6002-6006. doi: 10.1007/s00464-021-08924-x. Epub 2022 Jan 3.
- Background: PubMed 40638082Azuma S, Kobayashi Y, Harada R, Yane K, Sawada K, Tsujimoto A, Inatomi O, Matsumori T, Yoshimura K, Yazumi S, Kurita A. Local Postprocedural Cryoprevention Significantly Reduces the Incidence of Post-ERCP Pancreatitis: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2025 Jul 10. doi: 10.14309/ajg.0000000000003644. Online ahead of print.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water irrigation of the papilla and Rectal NSAID (diclofenac 100 mg) in people with Post ERCP Pancreatitis and Acute Pancreatitis (AP), run by University Hospital Virgen de las Nieves at 1 site in Spain.
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 5 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: opening soon, as of the sponsor's last update on 21 Oct 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 Spain. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Redondo-Cerezo, MD, PhD (+34 657373336, eredondoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-ERCP pancreatitis (Cotton criteria) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07885852, which also lists 8 linked publications.
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 21 Oct 2026.