Pancreatitis, AcuteNCT07738094
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
A study testing NSAID alone and Cryoprevention associated with NSAID in people with Pancreatitis, Acute, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- NSAID alone and Cryoprevention associated with NSAID
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jun 2026to 31 Aug 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
- Patients aged 18 years or older
- Clinical indication for ERCP
- Presence of native major duodenal papilla without previous manipulation
- Ability of the patient or companion to provide informed consent.
Who cannot join
- Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)
- Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)
- Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)
- Pregnant women
- Refusal to participate in the study or inability to sign the ICF
- Contraindication to NSAID use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.
São Paulo, São Paulo, 05403-000
Prof. Dr. Fauze Maluf Filho, +55 11 99191-9014, fauze.maluf@terra.com.br
Dr. Mateus Bond Boghossian, matbogho@gmail.com
About this study
Official title: Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial
The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.
Read the detailed description
This study aims to evaluate the efficacy of instilling ice-cold distilled water (4ºC to 5ºC) into the second duodenal portion as an adjunct to the standard practice of using NSAIDs, comparing it with a group using NSAIDs only to reduce the incidence of PEP. This is a randomized, sequential, blinded, 1:1 paired clinical trial conducted at a single tertiary center. An initial sample of 530 participants was calculated; considering a 10% drop-out, the final calculation was 583 people. All patients will undergo ERCP under sedation or general anesthesia and will be hydrated intravenously with lactated Ringer's. Rectal administration of NSAIDs (indomethacin 100mg) will be performed for all patients without contraindications. In the intervention group, immediately after the end of the therapeutic ERCP, 250 ml of ice-cold distilled water (4º to 5ºC) will be injected towards the papillary region. The control group will undergo standard ERCP and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
- Conditions
- Pancreatitis, Acute
- Being tested
- NSAID alone, Cryoprevention associated with NSAID
- Keywords
- Post-ERCP Pancreatitis, Cryoprevention, ERCP, NSAIDs
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAID aloneProcedure or surgery
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Cryoprevention associated with NSAIDProcedure or surgery
Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).
| Study group | Role | What they receive |
|---|---|---|
| NSAID alone | Active comparator | Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water. Receives: Procedure: NSAID alone |
| Cryoprevention associated with NSAID | Experimental | Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC). Receives: Procedure: Cryoprevention associated with NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-ERCP Pancreatitis (PEP).
New or worsened abdominal pain consistent with pancreatitis, associated with an elevation of serum amylase or lipase at least 3 times the upper limit of normal
Measured: Immediately after the procedure until 03 days after the procedure
Secondary outcomes (5)
PEP Severity
Classified as mild, moderate, or severe based on the length of hospital stay and local/systemic complications
Measured: Day 1 (24 hours post-procedure) and 7 days post-procedure
Cholangitis
Defined by fever, jaundice, and/or leukocytosis with evidence of biliary obstruction or need for reintervention.
Measured: Day 1 (24 hours post-procedure) and 7 days post-procedure
Bleeding
Clinical evidence of hemorrhage (melena, hematemesis) or drop in hemoglobin > 2g/dL requiring transfusion or endoscopic/surgical intervention.
Measured: Day 1 (24 hours post-procedure) and 7 days post-procedure
Perforation
Radiological or surgical evidence of air or luminal content leakage into the abdominal cavity or retroperitoneum.
Measured: Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure)
Mortality
Death from any cause up to 90 days after the procedure
Measured: Up to 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start9 Jun 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies 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 (Randomized 1:1 paired clinical trial)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 583 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fauze Maluf Filho, University of Sao Paulo
- Investigators
- Fauze Maluf Filho, Principal investigator, Hospital das Clínicas da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738094
- Sponsor's protocol ID
- 97150326.3.0000.0068
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: LGPD
Publications
Cotton 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 2070995Janssens LP, Yamparala A, Martin J, O'Meara J, Harmsen WS, Sathi T, Lemke E, Abu Dayyeh BK, Bofill-Garcia A, Petersen BT, Storm AC, Topazian M, Vargas EJ, Chandrasekhara V, Law RJ. Incidence of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin vs. Compounded Rectal Diclofenac Prophylaxis. Dig Dis Sci. 2024 Oct;69(10):3970-3978. doi: 10.1007/s10620-024-08604-5. Epub 2024 Aug 31.
PubMed 39215866Azuma 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 40638082Azuma 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 34977992Lee H, Natsui H, Akimoto T, Yanagi K, Ohshima N, Kono I. Effects of cryotherapy after contusion using real-time intravital microscopy. Med Sci Sports Exerc. 2005 Jul;37(7):1093-8. doi: 10.1249/01.mss.0000169611.21671.2e.
PubMed 16015124Dolan MG, Mychaskiw AM, Mendel FC. Cool-Water Immersion and High-Voltage Electric Stimulation Curb Edema Formation in Rats. J Athl Train. 2003 Sep;38(3):225-230.
PubMed 14608432ASGE STANDARDS OF PRACTICE COMMITTEE; Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Chowdhury A, Coelho-Prabhu N, Das R, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sadik J, Sheth SG, Thiruvengadam NR, Thosani NC, Zhou S, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: methodology and review of evidence. Gastrointest Endosc. 2023 Feb;97(2):163-183.e40. doi: 10.1016/j.gie.2022.09.011. Epub 2022 Dec 12. No abstract available.
PubMed 36517309Dumonceau 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 31863440Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
PubMed 22494121Tomoda T, Kato H, Ueki T, Akimoto Y, Hata H, Fujii M, Harada R, Ogawa T, Wato M, Takatani M, Matsubara M, Kawai Y, Okada H. Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2019 May;156(6):1753-1760.e1. doi: 10.1053/j.gastro.2019.01.267. Epub 2019 Feb 14.
PubMed 30772342Testoni PA, Mariani A, Giussani A, Vailati C, Masci E, Macarri G, Ghezzo L, Familiari L, Giardullo N, Mutignani M, Lombardi G, Talamini G, Spadaccini A, Briglia R, Piazzi L; SEIFRED Group. Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study. Am J Gastroenterol. 2010 Aug;105(8):1753-61. doi: 10.1038/ajg.2010.136. Epub 2010 Apr 6.
PubMed 20372116Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
PubMed 25088919
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07738094
- Acronym / sponsor ID
- 97150326.3.0000.0068
- Conditions
- Pancreatitis, Acute
- Keywords
- Post-ERCP Pancreatitis, Cryoprevention, ERCP, NSAIDs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 583 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Jul 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.
The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.
Detailed description
This study aims to evaluate the efficacy of instilling ice-cold distilled water (4ºC to 5ºC) into the second duodenal portion as an adjunct to the standard practice of using NSAIDs, comparing it with a group using NSAIDs only to reduce the incidence of PEP. This is a randomized, sequential, blinded, 1:1 paired clinical trial conducted at a single tertiary center. An initial sample of 530 participants was calculated; considering a 10% drop-out, the final calculation was 583 people. All patients will undergo ERCP under sedation or general anesthesia and will be hydrated intravenously with lactated Ringer's. Rectal administration of NSAIDs (indomethacin 100mg) will be performed for all patients without contraindications. In the intervention group, immediately after the end of the therapeutic ERCP, 250 ml of ice-cold distilled water (4º to 5ºC) will be injected towards the papillary region. The control group will undergo standard ERCP and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment (Randomized 1:1 paired clinical trial)
| Arm | Type | Receives |
|---|---|---|
| NSAID alone | Active comparator | Procedure: NSAID aloneStandard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water. |
| Cryoprevention associated with NSAID | Experimental | Procedure: Cryoprevention associated with NSAIDStandard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Clinical indication for ERCP
- Presence of native major duodenal papilla without previous manipulation
- Ability of the patient or companion to provide informed consent.
Key exclusion criteria (6 listed)
- Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)
- Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)
- Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)
- Pregnant women
- Refusal to participate in the study or inability to sign the ICF
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 |
|---|---|---|
| NSAID aloneStandard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water. | Procedure or surgery | NSAID alone |
| Cryoprevention associated with NSAIDStandard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC). | Procedure or surgery | Cryoprevention associated with NSAID |
Primary outcome
Incidence of Post-ERCP Pancreatitis (PEP).
Time frame: Immediately after the procedure until 03 days after the procedure
New or worsened abdominal pain consistent with pancreatitis, associated with an elevation of serum amylase or lipase at least 3 times the upper limit of normal
5 secondary outcomes
PEP Severity
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Cholangitis
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Bleeding
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Perforation
Time frame: Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure)
Mortality
Time frame: Up to 90 days post-procedure
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 25 Aug 2026.
- 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 39215866Janssens LP, Yamparala A, Martin J, O'Meara J, Harmsen WS, Sathi T, Lemke E, Abu Dayyeh BK, Bofill-Garcia A, Petersen BT, Storm AC, Topazian M, Vargas EJ, Chandrasekhara V, Law RJ. Incidence of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin vs. Compounded Rectal Diclofenac Prophylaxis. Dig Dis Sci. 2024 Oct;69(10):3970-3978. doi: 10.1007/s10620-024-08604-5. Epub 2024 Aug 31.
- 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.
- 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 16015124Lee H, Natsui H, Akimoto T, Yanagi K, Ohshima N, Kono I. Effects of cryotherapy after contusion using real-time intravital microscopy. Med Sci Sports Exerc. 2005 Jul;37(7):1093-8. doi: 10.1249/01.mss.0000169611.21671.2e.
- Background: PubMed 14608432Dolan MG, Mychaskiw AM, Mendel FC. Cool-Water Immersion and High-Voltage Electric Stimulation Curb Edema Formation in Rats. J Athl Train. 2003 Sep;38(3):225-230.
- Background: PubMed 36517309ASGE STANDARDS OF PRACTICE COMMITTEE; Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Chowdhury A, Coelho-Prabhu N, Das R, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sadik J, Sheth SG, Thiruvengadam NR, Thosani NC, Zhou S, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: methodology and review of evidence. Gastrointest Endosc. 2023 Feb;97(2):163-183.e40. doi: 10.1016/j.gie.2022.09.011. Epub 2022 Dec 12. No abstract available.
- 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 22494121Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
- Background: PubMed 30772342Tomoda T, Kato H, Ueki T, Akimoto Y, Hata H, Fujii M, Harada R, Ogawa T, Wato M, Takatani M, Matsubara M, Kawai Y, Okada H. Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2019 May;156(6):1753-1760.e1. doi: 10.1053/j.gastro.2019.01.267. Epub 2019 Feb 14.
- Background: PubMed 20372116Testoni PA, Mariani A, Giussani A, Vailati C, Masci E, Macarri G, Ghezzo L, Familiari L, Giardullo N, Mutignani M, Lombardi G, Talamini G, Spadaccini A, Briglia R, Piazzi L; SEIFRED Group. Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study. Am J Gastroenterol. 2010 Aug;105(8):1753-61. doi: 10.1038/ajg.2010.136. Epub 2010 Apr 6.
- Background: PubMed 25088919Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
- Individual participant dataSharing planned: No. LGPD
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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.
Fauze Maluf Filho principal investigator
Hospital das Clínicas da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID alone and Cryoprevention associated with NSAID in people with Pancreatitis, Acute, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Aug 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 Brazil. 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 Prof. Dr. Fauze Maluf Filho (+55 11 99191-9014, fauze.maluf@terra.com.br), 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 (PEP). (time frame: Immediately after the procedure until 03 days after the procedure). 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 NCT07738094, which also lists 12 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 25 Aug 2026.