Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis

NCT02497872 | Completed

• 1 other identifier: ERCP001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Post-ERCP Pancreatitis

  48 hours

Study Arms (2)

Early Precut Sphincterectomy

EXPERIMENTAL

Biliary stone removal using early precut: Patients enrolled in this arm received biliary drainage through a small incision on the papilla with an endoscopic needle-knife - a technique called precut sphincterotomy.

Procedure: Biliary stone removal

Pancreatic Duct Stent

ACTIVE COMPARATOR

Biliary stone removal using persistence of cannulation and a later pancreatic duct stent placement: Patients enrolled in this arm received conventional biliary drainage through persistent biliary cannulation. After completion of biliary drainage, a prophylactic pancreatic duct stent was placed.

Procedure: Biliary stone removal

Interventions

Biliary stone removal PROCEDURE

Biliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography

Early Precut Sphincterectomy; Pancreatic Duct Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with contrast allergy
• pregnant women
• patients unable to sign informed consent

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: July 15, 2015
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 15, 2015

Record last verified: 2015-07