Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones

October 27, 2023 updated by: Ahmed Bahaa Abdelazim, Sohag University

During the last decades, endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for the treatment of many pancreaticobiliary diseases [Canena et al., 2014]. However, ERCP is a challenging technique with a slow learning curve and is associated with complications, some of them lifethreatening [Chandrasekhara et al., 2017].

Post-ERCP pancreatitis (PEP) is the most common and serious complication after ERCP [Testoni et al., 2016]. A systematic survey of prospective studies including 16,885 patients reported an incidence of PEP of approximately 3.5%. Severe pancreatitis was found in 11% of the cases, and death occurred in 3% of PEP cases [Andriulli et al., 2007]. Therefore, many attempts to reduce the rate of this complication have been pursued. Selective cannulation of the common bile duct (CBD) is still considered to be a prerequisite for biliary sphincterotomy. Despite the use of various endoscopic retrograde cholangiopancreatography (ERCP) catheters and wire-guided sphincterotomes, CBD cannulation has been reported to fail in 5 % - 20 % of cases [Larkin and Huibregtse, 2001]. Precut sphincterotomy can allow access to the bile duct in such cases and is widely performed by expert endoscopists when there is a clear indication for endoscopic intervention. However, the use of precut sphincterotomy remains controversial because reported complication rates of the widely practiced needle-knife sphincterotomy (NKS) technique vary between 5 % and 20 % [Shakoor and Geenen, 1992]. Precut sphincterotomy, which includes needle-knife papillotomy (NKP), septotomy, and needle-knife fistulotomy (NKF), is often performed to facilitate access to the common bile duct of patients with difficult biliary access (DBA). Furthermore, NKF has been recommended as the preferred technique for precutting by the European Society of Gastrointestinal Endoscopy [Testoni et al., 2016] and the latest International Consensus[Liao et al., 2017]. The success of NKS also depends on the expertise of the endoscopist, and the consensus opinion is that this technique should only be performed by experienced endoscopists [Baillie,1997 ]. In contrast to NKS, incision of the papilla of Vater using an Erlangen-type precut sphincterotome has been previously reported by Binmoeller et al group to be an effective and safe auxiliary method for achieving access to the CBD after failed cannulation attempts [Binmoeller et al., 1996]. The definition of DBA varied widely [Mariani et al., 2016]. The latest guidelines for the definition of DBA differed widely from the latest guideline of The European Society of Gastrointestinal Endoscopy (defining DBA as the presence of ≥1 of the following: >5 contacts with the papilla while attempting to cannulate; >5 minutes spent attempting to cannulate following visualization of the papilla; >1 2 unintended pancreatic duct cannulation or opacification) [Testoni et al., 2016]. and the International Consensus Panel (defining DBA as the inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or up to 5 attempts or failure of access to the major papilla) [Liao et al., 2017 ].

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Asmaa N Mohamed, professor

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with difficult biliary access (DBA) consenting to randomization in an interventional design randomized controlled trials (RCTs) that compare precut sphincterotomy (EPS) with persistent cannulation attempts (PCA).
  • Patients who required biliary cannulation but without previous sphincterotomy.

Exclusion Criteria:

-Patients with coagulopathy or acute pancreatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
sphencterotomy of papilla by conventuional methodes
Procedure: sphincterotomy
cutting the papilla and cannulation with sweeping of common bile duct by ballon and stent insertion
Active Comparator: group B
precutting of the papilla by knife needle
Procedure: precutting of the papilla by knife needle
precutting of the papilla by knife needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones
Time Frame: 12 months
we will assess differences between conventional sphincterotomy and primary precutting as regard which methode will be easier in cannulation, which methode wil produce more complications as acute pancreatitis, bleeding or git perforation during managment of large common bile duct stones
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-23-09-3MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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