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Recruiting NCT07574970

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

— Observational Pancreas Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pancreas Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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 1. Rectal NSAIDs reduce but do not eliminate PEP. 2. Cold-water ampullary cooling is biologically plausible but under-studied. 3. First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect. 4. 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)

Primary outcome measures

  • Categorisation of Post ERCP Pancreatitis [Time frame: 10 Days]
Secondary outcome measures (3)
  • 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]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

India · 1 center
  • Asian institute of Gastroenterology/AIG Hospitals — Hyderabad

Identifiers

NCT: NCT07574970 · IWCRCT1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗