Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis

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.

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Key information

Conditions

Common Bile Duct Stones

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biliary stone removal

Procedure

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

Primary outcomes

Post-ERCP Pancreatitis

Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 15, 2015
Registry last updated: Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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