Post-ERCP PancreatitisPhase 4NCT07247682
Dose-escalation of Rectal Indomethacin for Preventing PEP
A Phase 4 study testing standard-dose group VS high-dose group in people with Post-ERCP Pancreatitis, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- standard-dose group VS high-dose group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Dec 2028
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Participants will be eligible for enrollment if they meet all of the following criteria: 1. age over 18 years; 2. classified as high risk for post-ERCP pancreatitis; 3. provision of signed, written informed consent.
Exclusion Criteria:Participants will be excluded if they meet any of the following conditions: 1. inaccessible major papilla; 2. surgically altered gastrointestinal anatomy; 3. current diagnosis of acute pancreatitis; 4. placement of a pancreatic stent; 5. contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease; 6. anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease; 8. pregnancy or breastfeeding; 9. presence of an ampullary tumor.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Qiming Huang, MD, 8617730145813, qimhuang@163.com
About this study
Official title: Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).
Read the detailed description
Evidence suggests that escalating the rectal indometacin dose to 200 mg offers no clear advantage over the standard 100 mg regimen in high-risk patients. However, the majority of participants (76%) had received pancreatic stent placement, raising the possibility that the benefit of the supplementary strategy may have been obscured by the considerable efficacy of pancreatic stenting. Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- standard-dose group VS high-dose group
- Keywords
- post-ERCP pancreatitis, indometacin, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard-dose group VS high-dose groupDrug
A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group)
| Study group | Role | What they receive |
|---|---|---|
| standard-dose group | Active comparator | administration of 100 mg rectal indometacin immediately after ERCP Receives: Drug: standard-dose group VS high-dose group |
| high-dose group | Experimental | administration of 200 mg rectal indometacin immediately after ERCP Receives: Drug: standard-dose group VS high-dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence and severity of PEP
Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaofei Wang, Principal investigator, Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247682
- Sponsor's protocol ID
- FirstHAnhuiMU1
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to promoting transparency and open science. Upon reasonable request and under certain conditions, individual participant data (IPD) from our study may be shared for further research. Access to the IPD will be considered on a case-by-case basis, following review and approval of a formal proposal by Qiao Mei. To inquire about accessing the IPD, interested parties may contact Qiao Mei at meiqiaomq@aliyun.com. Please note that data sharing is contingent upon meeting the criteria for ethical use, privacy, and confidentiality as outlined in our data sharing policy. Additionally, appropriate data transfer agreements may need to be established prior to sharing.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07247682
- Acronym / sponsor ID
- FirstHAnhuiMU1
- Conditions
- Post-ERCP Pancreatitis
- Keywords
- post-ERCP pancreatitis, indometacin, ERCP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,036 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 25 Nov 2025 (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.
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).
Detailed description
Evidence suggests that escalating the rectal indometacin dose to 200 mg offers no clear advantage over the standard 100 mg regimen in high-risk patients. However, the majority of participants (76%) had received pancreatic stent placement, raising the possibility that the benefit of the supplementary strategy may have been obscured by the considerable efficacy of pancreatic stenting. Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-dose group | Active comparator | Drug: standard-dose group VS high-dose groupadministration of 100 mg rectal indometacin immediately after ERCP |
| high-dose group | Experimental | Drug: standard-dose group VS high-dose groupadministration of 200 mg rectal indometacin immediately after ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| standard-dose group VS high-dose groupA total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group) | Drug | high-dose group, standard-dose group |
Primary outcome
the incidence and severity of PEP
Time frame: up to 1 months
Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
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 Nov 2025.
- Individual participant dataSharing planned: No. We are committed to promoting transparency and open science. Upon reasonable request and under certain conditions, individual participant data (IPD) from our study may be shared for further research. Access to the IPD will be considered on a case-by-case basis, following review and approval of a formal proposal by Qiao Mei. To inquire about accessing the IPD, interested parties may contact Qiao Mei at meiqiaomq@aliyun.com. Please note that data sharing is contingent upon meeting the criteria for ethical use, privacy, and confidentiality as outlined in our data sharing policy. Additionally, appropriate data transfer agreements may need to be established prior to sharing.
Related trials for Post-ERCP Pancreatitis
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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
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Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
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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.
Shaofei Wang principal investigator
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard-dose group VS high-dose group in people with Post-ERCP Pancreatitis, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Nov 2025. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qiao Mei, MD (8613865977696, meiqiaomq@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and severity of PEP (time frame: up to 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.