Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis

NCT ID: NCT02497872

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Common Bile Duct Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early Precut Sphincterectomy

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.

Group Type: EXPERIMENTAL

Biliary stone removal

Intervention Type: PROCEDURE

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

Pancreatic Duct Stent

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.

Group Type: ACTIVE_COMPARATOR

Biliary stone removal

Intervention Type: PROCEDURE

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

Interventions

Biliary stone removal

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER

Sponsor Role: lead

Responsible Party

Juan Lasa

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ERCP001

Identifier Type: -

Identifier Source: org_study_id