Post-ERCP Acute PancreatitisNCT05857514
Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis
A study testing Rectal Indomethacin and Prophylactic Pancreatic duct stenting in people with Post-ERCP Acute Pancreatitis, run by Moti Lal Nehru Medical College at 2 sites in India.
Trial summary
The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Rectal Indomethacin and Prophylactic Pancreatic duct stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesIndia
- Study dates
- 10 May 2023to 1 May 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected sphincter of Oddi dysfunction
- History of post ERCP Pancreatitis
- Pancreatic instrumentation or sphincterotomy.
- Precut sphincteroyomy
- Difficult cannulation defined by more than 5 cannulation attempts
- The use of double wire technique in bile duct access
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- At least 2 of the followings including
- Female age < 50 year
- 3 pancreatogram
- Acinarization (Contrast injection to tail of pancreas
- Normal serum bilirubin
- Guidewire to the tail of pancreas or secondary branches
Who cannot join
- Patient planned for pancreatic stenting
- Without informed consent
- Age < 18 years
- Pregnant women
- Lactating women
- Patient with altered anatomy
Show all 11Show fewer
- Contraindications to the use of NSAIDS
- Renal failure
- Ongoing or recent hospitalisation for acute pancreatitis
- Allergy to aspirin or NSAIDs
- known chronic calcific pancreatitis -
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Not yet recruiting
Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital
Allahābād, Uttar Pradesh, 211001
Mukti Pr Meher, MBBS, MD, 9556694521 ext. 9178719869, drmuktiprakash@gmail.com
- Recruiting
Department of Gastroenterology and Hepatology
Allahābād, Uttar Pradesh, 211001
Mukti Pr Meher, MD, 9556694521 ext. 9178719869, drmuktiprakash@gmail.com
About this study
Official title: A Prospective, Open Label Randomized Controlled Trial of Prophylactic Rectal Indomethacin Versus Combined Pancreatic Duct Stent Placement and Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis
The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.
If there is a comparison group: Researchers will compare [rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.] to see if [whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis].
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Rectal Indomethacin, Prophylactic Pancreatic duct stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal IndomethacinDrug
Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis
Prophylactic Pancreatic duct stentingProcedure or surgery
Also called Rectal indomethacin 100 mg
Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis
| Study group | Role | What they receive |
|---|---|---|
| Rectal indomethacin | Active comparator | Not described Receives: Drug: Rectal Indomethacin |
| Pancreatic duct stent and rectal indomethacin | Active comparator | Not described Receives: Procedure: Prophylactic Pancreatic duct stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
For comparison between these two arms the investigators will measure serum amylase in U/L value after 6 hour and 24 hour of the ERCP procedure. The investigators will also assess for pain abdomen and vomiting suggestive of acute pancreatitis.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start10 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute 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
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moti Lal Nehru Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mukti Prakash Meher, Moti Lal Nehru Medical College
- Investigators
- Mukti Pr Meher, MBBS, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857514
- Sponsor's protocol ID
- ECR/922/inst/UP/RR-2
- Status last verified
- Jun 2023
- First submitted
- 9 Apr 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Randomized Controlled Trial of Prophylactic Rectal Indomethacin Versus Combined Pancreatic Duct Stent Placement and Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT05857514
- Acronym / sponsor ID
- ECR/922/inst/UP/RR-2
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Moti Lal Nehru Medical CollegeOther government
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 12 May 2023 (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 goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.
If there is a comparison group: Researchers will compare [rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.] to see if [whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal indomethacin | Active comparator | Drug: Rectal Indomethacin |
| Pancreatic duct stent and rectal indomethacin | Active comparator | Procedure: Prophylactic Pancreatic duct stenting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Suspected sphincter of Oddi dysfunction
- History of post ERCP Pancreatitis
- Pancreatic instrumentation or sphincterotomy.
- Precut sphincteroyomy
- Difficult cannulation defined by more than 5 cannulation attempts
Key exclusion criteria (11 listed)
- Patient planned for pancreatic stenting
- Without informed consent
- Age < 18 years
- Pregnant women
- Lactating women
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 IndomethacinProphylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis | Drug | Rectal indomethacin |
| Prophylactic Pancreatic duct stentingAlso: Rectal indomethacin 100 mgProphylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis | Procedure or surgery | Pancreatic duct stent and rectal indomethacin |
Primary outcome
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
Time frame: 24 hour
For comparison between these two arms the investigators will measure serum amylase in U/L value after 6 hour and 24 hour of the ERCP procedure. The investigators will also assess for pain abdomen and vomiting suggestive of acute pancreatitis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Post-ERCP Acute 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)
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
RecruitingObservational study
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
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Not yet recruitingPhase 4
Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
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.
Mukti Pr Meher, MBBS, MD principal investigator
Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal Indomethacin and Prophylactic Pancreatic duct stenting in people with Post-ERCP Acute Pancreatitis, run by Moti Lal Nehru Medical College at 2 sites in India.
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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mukti Pr Meher, MBBS, MD (9556694521 ext. 9178719869, drmuktiprakash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis (time frame: 24 hour). 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 28 Jun 2023.