ERCPINSPIRENCT07329790
Indian National Study to Assess Incidence and Severity of Post-ERCP Pancreatitis After Following SOP
An observational study of ERCP, run by Asian Institute of Gastroenterology, India.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ERCP
- How many people
- 2,366 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Jul 2026
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2366
Who may be able to join
- Consecutive ERCPs during the enrollment window.
- Males and females between 18 and 75 years of age who ca comprehend instructions, follow study procedures, willing to sign an informed consent form and have a clinical indication to undergo a ERCP.
- Patients undergoing ERCP for therapeutic indications
- Patients with intact papilla
Who cannot join
- patient undergoing ERCP for diagnostic indications
- Acute pancreatitis
- Previous sphincterotomy
- Altered anatomy, defined as anatomical variations in which bile and/or pancreatic secretion donot enter the duodenum by way of the ampulla of Vater
- Pregnancy
- Signs of Congestive heart failure, such as pitting edema or a NYHA classification greater than class II heart failure.
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- Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation).
- Severe liver disease (cirrhosis and ascites)
- Contraindication for rectal indomethacin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery. However, despite its therapeutic efficacy, ERCP carries a significant risk of procedure-related adverse events, of which post-ERCP pancreatitis (PEP) is the most common and clinically important complication.
The reported incidence of PEP in prospective multicenter studies ranges from 7 % to 10 % in unselected populations, and may increase to 15 % or higher in high-risk subsets such as patients with difficult cannulation, sphincter of Oddi dysfunction, or a prior history of pancreatitis or PEP. Although the majority of cases are mild and self-limited, a small but important proportion (approximately 10-15 %) progress to moderate or severe disease, resulting in prolonged hospitalization, increased cost, and occasionally mortality.
Over the past two decades, extensive research has improved our understanding of PEP pathogenesis and risk stratification. Several patient-related (younger age, female sex, prior PEP or pancreatitis, sphincter of Oddi dysfunction, asymptomatic choledocholithiasis) and procedure-related (difficult cannulation, pancreatic duct contrast injection or guidewire passage, pancreatic sphincterotomy, endoscopic papillary balloon dilation) predictors have been identified.
- Conditions
- ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal NSAID Prophylaxis | Participants who receive a single dose of rectal indomethacin or diclofenac (100 mg suppository) as part of routine clinical practice. The dose is given 30 minutes before ERCP, or immediately after the procedure if the pre-procedure dose was missed. | |
| Pancreatic Duct Stent Placement | Participants in whom the pancreatic duct is accessed during ERCP and a small plastic prophylactic pancreatic duct stent is placed as part of standard care. The stent is temporary and is expected to pass naturally or be removed within 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-ERCP pancreatitis (PEP), defined as
- New or worsened abdominal pain after ERCP with serum amylase or lipase ≥3 × the upper limit of normal measured ≥24 hours post-procedure,
- Accompanied by hospitalization or prolongation of hospital stay attributable to pancreatitis.
Measured: 30 days
Secondary outcomes (1)
Severity of PEP
Mild, moderate, or severe according to the Revised Atlanta Classification (based on organ failure and duration of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- MD NITIN JAGTAP, MD,DM, Principal investigator, Asian Institute Of Gastroenterology Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329790
- Sponsor's protocol ID
- INSPIRE
- Acronym
- INSPIRE
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian National Study to Assess Incidence and Severity of Post-ERCP Pancreatitis After Following SOP
- ClinicalTrials.gov ID
- NCT07329790
- Acronym / sponsor ID
- INSPIRE / INSPIRE
- Conditions
- ERCP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,366 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 Jan 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 an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery. However, despite its therapeutic efficacy, ERCP carries a significant risk of procedure-related adverse events, of which post-ERCP pancreatitis (PEP) is the most common and clinically important complication.
The reported incidence of PEP in prospective multicenter studies ranges from 7 % to 10 % in unselected populations, and may increase to 15 % or higher in high-risk subsets such as patients with difficult cannulation, sphincter of Oddi dysfunction, or a prior history of pancreatitis or PEP. Although the majority of cases are mild and self-limited, a small but important proportion (approximately 10-15 %) progress to moderate or severe disease, resulting in prolonged hospitalization, increased cost, and occasionally mortality.
Over the past two decades, extensive research has improved our understanding of PEP pathogenesis and risk stratification. Several patient-related (younger age, female sex, prior PEP or pancreatitis, sphincter of Oddi dysfunction, asymptomatic choledocholithiasis) and procedure-related (difficult cannulation, pancreatic duct contrast injection or guidewire passage, pancreatic sphincterotomy, endoscopic papillary balloon dilation) predictors have been identified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal NSAID Prophylaxis | – | –Participants who receive a single dose of rectal indomethacin or diclofenac (100 mg suppository) as part of routine clinical practice. The dose is given 30 minutes before ERCP, or immediately after the procedure if the pre-procedure dose was missed. |
| Pancreatic Duct Stent Placement | – | –Participants in whom the pancreatic duct is accessed during ERCP and a small plastic prophylactic pancreatic duct stent is placed as part of standard care. The stent is temporary and is expected to pass naturally or be removed within 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2366
Key inclusion criteria (4 listed)
- Consecutive ERCPs during the enrollment window.
- Males and females between 18 and 75 years of age who ca comprehend instructions, follow study procedures, willing to sign an informed consent form and have a clinical indication to undergo a ERCP.
- Patients undergoing ERCP for therapeutic indications
- Patients with intact papilla
Key exclusion criteria (9 listed)
- patient undergoing ERCP for diagnostic indications
- Acute pancreatitis
- Previous sphincterotomy
- Altered anatomy, defined as anatomical variations in which bile and/or pancreatic secretion donot enter the duodenum by way of the ampulla of Vater
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of post-ERCP pancreatitis (PEP), defined as
Time frame: 30 days
* New or worsened abdominal pain after ERCP with serum amylase or lipase ≥3 × the upper limit of normal measured ≥24 hours post-procedure, * Accompanied by hospitalization or prolongation of hospital stay attributable to pancreatitis.
1 secondary outcome
Severity of PEP
Time frame: 30 days
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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for ERCP
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
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Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
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Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
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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.
MD NITIN JAGTAP, MD,DM principal investigator
Asian Institute Of Gastroenterology Private Limited
Questions about this trial
What is this clinical trial studying?
An observational study of ERCP, run by Asian Institute of Gastroenterology, 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 DR NITIN JAGTAP, MD,DM (8712015028, docsnitin13@gmail.com), 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), defined as (time frame: 30 days). 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 12 Jan 2026.