Pancreas DiseaseERCPNCT07574970
A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT
An observational study of Pancreas Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pancreas Disease
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2025to 30 Dec 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 60 years
- All sexes
- Adult
Study population: 150
Who may be able to join
- Standard ERCP indication
- Consent given
Who cannot join
- Pregnancy and lactation
- Chronic calcific pancreatitis / pancreatic divisum / pancreatic head
- malignancy / acute pancreatitis within 14 days of ERCP
- ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
- Chronic kidney disease with GFR <30 or acute kidney injury.
- Presence of rectal anomaly
Show all 11Show fewer
- Active GI bleeding or high bleeding risk precluding NSAIDs;platelet <50000/L;INR >1.5 not correctable
- NSAID allergy
- Cirrhosis Child-Pugh C
- Temp instability or severe cardiopulmonary disease precluding cooling/shock risk.
- Sphincter of Oddi dysfunction (Type 3)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500079
Rajesh Goud Mr Maragoni, M.Pharm, MBA, 04023378888 ext. 531, rajeshgoud761@gmail.com
Zaheer Nabi Dr Mohammed, MBBS, MD, 04023378888 ext. 102, zaheernabi1978@gmail.com
About this study
Official title: A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF PEP
Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin/diclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE/ESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy/instrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP
- Rectal NSAIDs reduce but do not eliminate PEP.
- Cold-water ampullary cooling is biologically plausible but under-studied.
- First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.
- First study in Indian population.
Read the detailed description
- Assess whether combination therapy reduces PEP compared to NSAIDS alone.
Secondary Aims:
- Compare PEP severity (Cotton grading and revised Atlanta criteria).
- Adverse effects
- Length of hospital stay and/or intensive care unit stay
- Assess feasibility and adherence and fidelity of cooling protocol.
- Explore effect modification by baseline PEP risk (average vs high-risk), type of intervention (diagnostic vs therapeutic ERCP), and prophylactic pancreatic stenting use
DESIGN AND DURATION OF THE STUDY: Single centre pilot randomised control superiority trail over 12 months with 30 days followup
INCLUSION / EXCLUSION CRITERIA:
- Inclusion criteria:
- Standard ERCP indication
- Consent given
- Exclusion criteria:
- Pregnancy and lactation
- Chronic calcific pancreatitis / pancreatic divisum / pancreatic head malignancy / acute pancreatitis within 14 days of ERCP
- ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
- Chronic kidney disease with GFR <30 or acute kidney injury.
- Presence of rectal anomaly
- Active GI bleeding or high bleeding risk precluding NSAIDs;platelet <50000/L;INR >1.5 not correctable
- NSAID allergy
- Cirrhosis Child-Pugh C
- Temp instability or severe cardiopulmonary disease precluding cooling/shock risk.
- Sphincter of Oddi dysfunction (Type 3)
- Conditions
- Pancreas Disease
- Medical subject headings
- Pancreatic Diseases
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 Indomethacin plus Papilary spay of Cold saline | Intervention group: Rectal indomethacin( 100 mg suppository administered 30-60 minutes pre ERCP + cold saline irrigation (4 - 10°C, 250 mL, 2 min) | |
| Rectal Indomethacin alone | Rectal indomethacin should be administered to the patient before 30 minutes ERCP procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorisation of Post ERCP Pancreatitis
Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus
Measured: 10 Days
Secondary outcomes (3)
Serum amylase and lipase 24 hours post ERCP.
To evaluate the serum amylase and lipase levels 24 hours after ERCP procedure
Measured: 24 hours
Abdomen pain score assessment
To check pain levels every 4 hours up to 24 hours post ERCP procedure
Measured: 24 hours
Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia
To detect adverse events post procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Dec 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 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
- Mohan Dr Ramchandani, MD DM, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574970
- Sponsor's protocol ID
- IWCRCT1
- Acronym
- ERCP
- Status last verified
- Nov 2025
- First submitted
- 4 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF PEP
- ClinicalTrials.gov ID
- NCT07574970
- Acronym / sponsor ID
- ERCP / IWCRCT1
- Conditions
- Pancreas Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 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) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin/diclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE/ESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy/instrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP
- Rectal NSAIDs reduce but do not eliminate PEP.
- Cold-water ampullary cooling is biologically plausible but under-studied.
- First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.
- First study in Indian population.
Detailed description
- Assess whether combination therapy reduces PEP compared to NSAIDS alone.
Secondary Aims:
- Compare PEP severity (Cotton grading and revised Atlanta criteria).
- Adverse effects
- Length of hospital stay and/or intensive care unit stay
- Assess feasibility and adherence and fidelity of cooling protocol.
- Explore effect modification by baseline PEP risk (average vs high-risk), type of intervention (diagnostic vs therapeutic ERCP), and prophylactic pancreatic stenting use
DESIGN AND DURATION OF THE STUDY: Single centre pilot randomised control superiority trail over 12 months with 30 days followup
INCLUSION / EXCLUSION CRITERIA:
- Inclusion criteria:
- Standard ERCP indication
- Consent given
- Exclusion criteria:
- Pregnancy and lactation
- Chronic calcific pancreatitis / pancreatic divisum / pancreatic head malignancy / acute pancreatitis within 14 days of ERCP
- ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
- Chronic kidney disease with GFR <30 or acute kidney injury.
- Presence of rectal anomaly
- Active GI bleeding or high bleeding risk precluding NSAIDs;platelet <50000/L;INR >1.5 not correctable
- NSAID allergy
- Cirrhosis Child-Pugh C
- Temp instability or severe cardiopulmonary disease precluding cooling/shock risk.
- Sphincter of Oddi dysfunction (Type 3)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal Indomethacin plus Papilary spay of Cold saline | – | –Intervention group: Rectal indomethacin( 100 mg suppository administered 30-60 minutes pre ERCP + cold saline irrigation (4 - 10°C, 250 mL, 2 min) |
| Rectal Indomethacin alone | – | –Rectal indomethacin should be administered to the patient before 30 minutes ERCP procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 150
Key inclusion criteria (2 listed)
- Standard ERCP indication
- Consent given
Key exclusion criteria (11 listed)
- Pregnancy and lactation
- Chronic calcific pancreatitis / pancreatic divisum / pancreatic head
- malignancy / acute pancreatitis within 14 days of ERCP
- ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
- Chronic kidney disease with GFR <30 or acute kidney injury.
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
Categorisation of Post ERCP Pancreatitis
Time frame: 10 Days
Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus
3 secondary outcomes
Serum amylase and lipase 24 hours post ERCP.
Time frame: 24 hours
Abdomen pain score assessment
Time frame: 24 hours
Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia
Time frame: 24 hours
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 Jun 2026.
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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.
Mohan Dr Ramchandani, MD DM study director
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease, run by Asian Institute of Gastroenterology, India at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 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?
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 Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA (04023378888 ext. 312, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Categorisation of Post ERCP Pancreatitis (time frame: 10 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 Jun 2026.