Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis

Common Bile Duct Stones Clinical Trial

Official title:

Early Precut Versus Pancreatic Duct Stent in Preventing Post-ERCP Pancreatitis in High-risk Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497872
• Other study ID #: ERCP001
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: July 12, 2015
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Bile Duct Stones
• Pancreatitis

Intervention

Procedure:
• Biliary stone removal
Biliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP Pancreatitis		48 hours	Yes