Early Precut Versus Pancreatic Duct Stent in Preventing Post-ERCP Pancreatitis in High-risk Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Post-ERCP Pancreatitis
Study Overview
Brief Summary
BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However, early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a preventive measure has not been compared to other preventive measures, such as pancreatic duct stent placement.
AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in high-risk subjects undergoing ERCP.
MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm. Only those who present a difficult biliary cannulation shall be randomized into two groups: those who receive early precut sphincterotomy or those in whom persistency of biliary cannulation is intended with subsequent pancreatic duct stent placement after cholangiography is achieved. The incidence of post-ERCP pancreatitis as well as other complications shall be compared.
Detailed Description
It is well known that pancreatitis is the most common and dreadful complication of endoscopic retrograde cholangiopancreatography (ERCP). Historically, precut sphincterotomy has been regarded as a risk factor for post-ERCP pancreatitis. However, some evidence has suggested that if used at an early point during the procedure, it may actually behave as a protective factor.
In high risk patients, such as those patients with sphincter of Oddi dysfunction, pancreatic duct stent placement has been considered to be a prophylactic measure against pancreatitis. However, pancreatic duct stent placement can sometimes be a cumbersome procedure, and may require additional procedures (mainly if spontaneous stent dislodgment is not accomplished). There is no evidence comparing early precut versus pancreatic duct stent placement in high-risk patients.
As a consequence, the aim of this study was to compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in patients presenting at least one risk factor for post-ERCP pancreatitis and difficult biliary cannulation.
A single-blinded, randomized trial was undertaken. Patients fulfilling inclusion criteria who presented with difficult biliary cannulation during ERCP were randomized to early precut or persistence in biliary cannulation with a sphincterotome with posterior pancreatic duct stent placement. The incidence of post-ERCP pancreatitis as well as other complications were compared between groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with in need for ERCP due to benign or malignant biliopancreatic conditions, with at least one of the following features:
- •female sex
- •age less than 40 years
- •clinical suspicion of Sphincter of Oddi Dysfunction
- •previous pancreatitis
- •common bile duct diameter of less than 8 mm
- •Subjects with difficult biliary cannulation, as defined by previously published criteria
Exclusion Criteria
- •patients with contrast allergy
- •pregnant women
- •patients unable to sign informed consent
Outcomes
Primary Outcomes
Post-ERCP Pancreatitis
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Juan Lasa
MD
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno