PancreatitisPhase 3Post-ERCPNCT07599605
Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis.
A Phase 3 study testing Rectal Indometacin in people with Pancreatitis and ERCP, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, ERCP
- What is being tested?
- Rectal Indometacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 4 Mar 2024to 17 Jan 2025
- Phase
- Phase 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
- Patients who required ERCP
- Without contraindications to the use of indomethacin or aggressive hydration
Who cannot join
- Patients with cardiac or renal alterations
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
Chihuahua City, Chihuahua, 31000
About this study
Official title: Efficacy of Rectal Indomethacin Plus Aggressive Hydration as Prophylaxis to Prevent Post-ERCP Pancreatitis at a Secondary-Care Teaching Hospital: A Randomized Controlled Trial.
Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.
Read the detailed description
A randomized controlled trial was conducted with 60 patients undergoing ERCP at a secondary-care teaching public hospital. Patients were divided into two groups: With and without prophylaxis. Differences in post-ERCP pancreatitis incidence and pancreatic enzyme levels before and after the procedure were analyzed.
- Conditions
- Pancreatitis, ERCP
- Being tested
- Rectal Indometacin
- Keywords
- ERCP, Rectal indomethacin, Hydration, Post-ERCP pancreatitis, Prophylaxis, Amylase, Lipase, Biliopancreatic complications
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal IndometacinDrug
Also called ERCP
The gold standard for treating diseases affecting the biliopancreatic ducts, choledocholithiasis being the most common indication, for which sphincterotomy is the most frequently performed procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) without prophylactic treatment |
| Prophylaxis Group | Experimental | The prophylaxis group received 100 mg of rectal indomethacin 30 minutes before the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, combined with intravenous Hartmann's solution administered at 3 mL/kg/hr during the procedure, plus a 20 mL/kg bolus given post-procedure, followed by continuous hydration at 3 mL/kg/hr for 8 hours Receives: Drug: Rectal Indometacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis
Pancreas inflammation after the ERCP procedure
Measured: From the end of the ERCP procedure through 24 hours
Post-ERCP pancreatitis
Pancreas inflammation due to the ERCP procedure
Measured: Ocurring in the first 24 hours posterior to the ERCP
Secondary outcomes (1)
Post-ERCP Pancreatic enzyme elevation
Elevation of the amylase and/or lipase after the ERCP procedure
Measured: Ocurring in the first 24 hours posterior to the ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start4 Mar 2024
- Primary completion27 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine if a prophylactic dose of rectal indomethacin plus an aggressive hydration scheme reduces the incidence of post-ERCP pancreatitis, a randomized controlled study (RCT) was designed in the surgery department of a secondary-care teaching hospital.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carlos R. Cervantes Sanchez, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Investigators
- Rubén Cuevas-Martínez, MD, MSc, Study chair, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599605
- Sponsor's protocol ID
- 0344/24
- Acronym
- Post-ERCP
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Out of respect for Mexican legislation regarding the confidentiality of information of private individuals
Publications
Aghajanpoor Pasha M, Eslami P, Dooghaie Moghadam A, Moazzami B, Shojaee S, Almasi F, Tavakolikia N, Norouzinia M, Radinnia E, Sadeghi A. The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients. Gastroenterol Hepatol Bed Bench. 2020 Winter;13(Suppl1):S81-S88.
PubMed 33585008Aljohani S, Mirghani H. Aggressive Hydration With Ringer's Lactate in the Prevention of Post-ERCP Pancreatitis: A Meta-Analysis. Cureus. 2021 May 7;13(5):e14897. doi: 10.7759/cureus.14897.
PubMed 34109084Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol. 2017 Mar 15;17(1):43. doi: 10.1186/s12876-017-0599-4.
PubMed 28298192Goyal H, Sachdeva S, Sherazi SAA, Gupta S, Perisetti A, Ali A, Chandan S, Tharian B, Sharma N, Thosani N. Early prediction of post-ERCP pancreatitis by post-procedure amylase and lipase levels: A systematic review and meta-analysis. Endosc Int Open. 2022 Jul 15;10(7):E952-E970. doi: 10.1055/a-1793-9508. eCollection 2022 Jul.
PubMed 35845027Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP Pancreatitis: Prevention, Diagnosis and Management. Medicina (Kaunas). 2022 Sep 12;58(9):1261. doi: 10.3390/medicina58091261.
PubMed 36143938Easler JJ, Fogel EL. Prevention of post-ERCP pancreatitis: the search continues. Lancet Gastroenterol Hepatol. 2021 May;6(5):336-337. doi: 10.1016/S2468-1253(21)00063-7. Epub 2021 Mar 19. No abstract available.
PubMed 33740414Borrelli de Andreis F, Mascagni P, Schepis T, Attili F, Tringali A, Costamagna G, Boskoski I. Prevention of post-ERCP pancreatitis: current strategies and novel perspectives. Ther Adv Gastroenterol. 2023 Mar 6;16:17562848231155984. doi: 10.1177/17562848231155984. eCollection 2023.
PubMed 36895283
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rectal Indomethacin Plus Aggressive Hydration as Prophylaxis to Prevent Post-ERCP Pancreatitis at a Secondary-Care Teaching Hospital: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07599605
- Acronym / sponsor ID
- Post-ERCP / 0344/24
- Conditions
- Pancreatitis, ERCP
- Keywords
- ERCP, Rectal indomethacin, Hydration, Post-ERCP pancreatitis, Prophylaxis, Amylase, Lipase, Biliopancreatic complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán AnchondoOther government
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 20 May 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 a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.
Detailed description
A randomized controlled trial was conducted with 60 patients undergoing ERCP at a secondary-care teaching public hospital. Patients were divided into two groups: With and without prophylaxis. Differences in post-ERCP pancreatitis incidence and pancreatic enzyme levels before and after the procedure were analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To determine if a prophylactic dose of rectal indomethacin plus an aggressive hydration scheme reduces the incidence of post-ERCP pancreatitis, a randomized controlled study (RCT) was designed in the surgery department of a secondary-care teaching hospital.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) without prophylactic treatment |
| Prophylaxis Group | Experimental | Drug: Rectal IndometacinThe prophylaxis group received 100 mg of rectal indomethacin 30 minutes before the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, combined with intravenous Hartmann's solution administered at 3 mL/kg/hr during the procedure, plus a 20 mL/kg bolus given post-procedure, followed by continuous hydration at 3 mL/kg/hr for 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who required ERCP
- Without contraindications to the use of indomethacin or aggressive hydration
Key exclusion criteria (1 listed)
- Patients with cardiac or renal alterations
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 |
|---|---|---|
| Rectal IndometacinAlso: ERCPThe gold standard for treating diseases affecting the biliopancreatic ducts, choledocholithiasis being the most common indication, for which sphincterotomy is the most frequently performed procedure. | Drug | Prophylaxis Group |
Primary outcome
Post-ERCP pancreatitis
Time frame: From the end of the ERCP procedure through 24 hours
Pancreas inflammation after the ERCP procedure
Post-ERCP pancreatitis
Time frame: Ocurring in the first 24 hours posterior to the ERCP
Pancreas inflammation due to the ERCP procedure
1 secondary outcome
Post-ERCP Pancreatic enzyme elevation
Time frame: Ocurring in the first 24 hours posterior to the 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 20 May 2026.
- Background: PubMed 33585008Aghajanpoor Pasha M, Eslami P, Dooghaie Moghadam A, Moazzami B, Shojaee S, Almasi F, Tavakolikia N, Norouzinia M, Radinnia E, Sadeghi A. The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients. Gastroenterol Hepatol Bed Bench. 2020 Winter;13(Suppl1):S81-S88.
- Background: PubMed 34109084Aljohani S, Mirghani H. Aggressive Hydration With Ringer's Lactate in the Prevention of Post-ERCP Pancreatitis: A Meta-Analysis. Cureus. 2021 May 7;13(5):e14897. doi: 10.7759/cureus.14897.
- Background: PubMed 28298192Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol. 2017 Mar 15;17(1):43. doi: 10.1186/s12876-017-0599-4.
- Background: PubMed 35845027Goyal H, Sachdeva S, Sherazi SAA, Gupta S, Perisetti A, Ali A, Chandan S, Tharian B, Sharma N, Thosani N. Early prediction of post-ERCP pancreatitis by post-procedure amylase and lipase levels: A systematic review and meta-analysis. Endosc Int Open. 2022 Jul 15;10(7):E952-E970. doi: 10.1055/a-1793-9508. eCollection 2022 Jul.
- Background: PubMed 36143938Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP Pancreatitis: Prevention, Diagnosis and Management. Medicina (Kaunas). 2022 Sep 12;58(9):1261. doi: 10.3390/medicina58091261.
- Background: PubMed 33740414Easler JJ, Fogel EL. Prevention of post-ERCP pancreatitis: the search continues. Lancet Gastroenterol Hepatol. 2021 May;6(5):336-337. doi: 10.1016/S2468-1253(21)00063-7. Epub 2021 Mar 19. No abstract available.
- Background: PubMed 36895283Borrelli de Andreis F, Mascagni P, Schepis T, Attili F, Tringali A, Costamagna G, Boskoski I. Prevention of post-ERCP pancreatitis: current strategies and novel perspectives. Ther Adv Gastroenterol. 2023 Mar 6;16:17562848231155984. doi: 10.1177/17562848231155984. eCollection 2023.
- Individual participant dataSharing planned: No. Out of respect for Mexican legislation regarding the confidentiality of information of private individuals
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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.
Rubén Cuevas-Martínez, MD, MSc study chair
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rectal Indometacin in people with Pancreatitis and ERCP, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
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 2 inclusion and 1 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 20 May 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 Mexico. 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 phase mean?
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?
Post-ERCP pancreatitis (time frame: From the end of the ERCP procedure through 24 hours). The study lists 2 primary outcomes in all. 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 NCT07599605, which also lists 7 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 20 May 2026.