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Clinical Trials/NCT06106724
NCT06106724
Recruiting
Not Applicable

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

Sohag University1 site in 1 country50 target enrollmentSeptember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Calcular Obstructive Jaundice
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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 ].

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
September 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Bahaa Abdelazim

assistant lecteurer tropical medicine department sohag univerisity hospital

Sohag University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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