Post-ERCP PancreatitisPhase 4NCT07088757
Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis
A Phase 4 study testing standard dose indomethacin and low dose indomethacin in people with Post-ERCP Pancreatitis, run by Changhai Hospital at 12 sites in China.
Trial summary
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- standard dose indomethacin and low dose indomethacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,366 participants
- Where
- 12 sitesChina
- Study dates
- 15 Sep 2025to 1 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography
Who cannot join
- Standard contraindications to ERCP
- Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Use of NSAIDs within 7 days prior to ERCP
- Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
- Acute pancreatitis within 3 days before ERCP
- Hemodynamic instability
- Pregnancy or lactation
- Patients who are unwilling or unable to provide informed consent
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zhao-Shen Li contact
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Changhai Hospital
Shanghai
Liang-Hao Hu, +8613817593520, lianghao-hu@hotmail.com
Zhao-Shen Li, zhaoshen-li@hotmail.com
- Recruiting
Ruijin Hospital
Shanghai
Duo-Wu Zou, +86 13901617608
- Not yet recruiting
Shanghai General Hospital
Shanghai
Bai-Wen Li, +86 18930894343
- Not yet recruiting
Affiliated Hospital of Jiaxing University
Zhejiang
Hong-Kun Zhou, +86 13586332200
- Not yet recruiting
Dongyang People's Hospital
Zhejiang
Bin Wang, +86 13857932995
- Not yet recruiting
First Affiliated Hospital of Ningbo University
Zhejiang
Liang Yang, +86 13777128020
- Not yet recruiting
Jinhua Central Hospital
Zhejiang
Xiao-Kang Wu, +86 13989411219
- Not yet recruiting
People's Hospital of Quzhou
Zhejiang
Zheng-fei Wang, +86 13587111668
- Not yet recruiting
Shaoxing People's Hospital
Zhejiang
Zhi-Liang Chen, +86 13305758802
- Recruiting
Sir Run Run Shaw Hospital
Zhejiang
Song-Mei Lou, +86 13958031730, srrshlsm@zju.edu.cn
- Recruiting
Taizhou Enze Medical Center Group
Zhejiang
Ai-Dong Wang, +86 13706766175
- Not yet recruiting
Zhuji People's Hospital of Zhejiang Province
Zhejiang
Jun Zhen, +86 13819522121
About this study
Official title: Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.
Read more
This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.
The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- standard dose indomethacin, low dose indomethacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard dose indomethacinDrug
Patients randomized to this intervention receive 100mg indomethacin suppositories within 30 min before ERCP.
low dose indomethacinDrug
Patients randomized to this intervention receive 50mg indomethacin suppositories within 30 min before ERCP.
| Study group | Role | What they receive |
|---|---|---|
| low dose indomethacin | Experimental | patients randomized to this intervention receive 50mg indomethacin Receives: Drug: low dose indomethacin |
| standard dose indomethacin | Active comparator | patients randomized to this intervention receive 100mg indomethacin Receives: Drug: standard dose indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis
Measured: Within 48 hours after ERCP
Secondary outcomes (6)
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis
Measured: Within one month of ERCP
Rate of Overall ERCP-related complications
ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Measured: Within one month of ERCP
Rate of ERCP-related perforation
Measured: Within one month of ERCP
Rate of ERCP-related infection
Measured: Within one month of ERCP
Rate of ERCP-related bleeding
Measured: Within one month of ERCP
Rate of NSAIDs-related complications
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
Measured: Within one month of ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Sep 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (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.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Ruijin Hospital, Shanghai General Hospital, China, Jinhua Central Hospital, Taizhou Enze Medical Center Group, Dongyang People's Hospital, Shaoxing People's Hospital, First Affiliated Hospital of Ningbo University, Affiliated Hospital of Jiaxing University, People's Hospital of Quzhou, Zhuji People's Hospital of Zhejiang Province
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088757
- Sponsor's protocol ID
- INSPIRE
- Status last verified
- Nov 2025
- First submitted
- 19 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT07088757
- Acronym / sponsor ID
- INSPIRE
- Conditions
- Post-ERCP Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,366 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Ruijin Hospital, Shanghai General Hospital, China, Jinhua Central Hospital, Taizhou Enze Medical Center Group, Dongyang People's Hospital, Shaoxing People's Hospital, First Affiliated Hospital of Ningbo University, Affiliated Hospital of Jiaxing University, People's Hospital of Quzhou, Zhuji People's Hospital of Zhejiang Province
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jul 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.
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.
This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.
The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose indomethacin | Experimental | Drug: low dose indomethacinpatients randomized to this intervention receive 50mg indomethacin |
| standard dose indomethacin | Active comparator | Drug: standard dose indomethacinpatients randomized to this intervention receive 100mg indomethacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older.
- Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography
Key exclusion criteria (8 listed)
- Standard contraindications to ERCP
- Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Use of NSAIDs within 7 days prior to ERCP
- Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
- Acute pancreatitis within 3 days before ERCP
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 indomethacinPatients randomized to this intervention receive 100mg indomethacin suppositories within 30 min before ERCP. | Drug | standard dose indomethacin |
| low dose indomethacinPatients randomized to this intervention receive 50mg indomethacin suppositories within 30 min before ERCP. | Drug | low dose indomethacin |
Primary outcome
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis
Time frame: Within 48 hours after ERCP
6 secondary outcomes
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis
Time frame: Within one month of ERCP
Rate of Overall ERCP-related complications
Time frame: Within one month of ERCP
Rate of ERCP-related perforation
Time frame: Within one month of ERCP
Rate of ERCP-related infection
Time frame: Within one month of ERCP
Rate of ERCP-related bleeding
Time frame: Within one month of ERCP
Rate of NSAIDs-related complications
Time frame: Within one month of ERCP
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Post-ERCP Pancreatitis
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
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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.
Zhao-Shen Li contact
12 sites 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 indomethacin and low dose indomethacin in people with Post-ERCP Pancreatitis, run by Changhai Hospital at 12 sites in China.
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 8 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 18 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 12 sites 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 Liang-Hao Hu (+8613817593520, lianghao-hu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis (time frame: Within 48 hours after ERCP). 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 18 Nov 2025.