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Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis

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ClinicalTrials.gov Identifier: NCT02497872
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Juan Lasa, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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.


Condition or disease Intervention/treatment Phase
Common Bile Duct Stones Procedure: Biliary stone removal Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Precut Versus Pancreatic Duct Stent in Preventing Post-ERCP Pancreatitis in High-risk Subjects
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Biliary stone removal
Biliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography

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




Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Juan Lasa, MD, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
ClinicalTrials.gov Identifier: NCT02497872     History of Changes
Other Study ID Numbers: ERCP001
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases