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NCT Number: NCT07329790

Indian National Study to Assess Incidence and Severity of Post-ERCP Pancreatitis After Following SOP

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Severity of PEP

    Time frame: 30 days

    Mild, moderate, or severe according to the Revised Atlanta Classification (based on organ failure and duration of hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

DR NITIN JAGTAP, MD,DM

CONTACT

[email protected]

8712015028

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Acronym: INSPIRE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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