ERCP
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Asian Institute of Gastroenterology, India
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ERCP pancreatitis (PEP), defined as | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of PEP | 30 days | Mild, moderate, or severe according to the Revised Atlanta Classification (based on organ failure and duration of hospitalization |
Contacts
Primary ContactDR NITIN JAGTAP, MD,DM
Outcome results
None listed