Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315647
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Brief Title:
Comparison Between Different Techniques in Difficult CBD Cannulation
Sponsor:
Menoufia University
Organization:
Menoufia University
Study Overview
Official Title:
Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the efficacy and outcomes between double guidewire technique DGT trans pancreatic sphincterotomy TPS as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation
Detailed Description:
Endoscopic retrograde cholangiopancreatography ERCP is the standard procedure for diagnostic and therapeutic interventions for pancreatobiliary diseases Bile duct cannulation is the most basic and important technique for carrying out diagnostic and therapeutic biliary interventions
Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures despite various accessory devices the standard biliary cannulation technique has been reported to fail in approximately 5-20 cases
Various endoscopic techniques for Selective Bile duct cannulation have been reported including standard techniques eg contrast injection technique wire-guided cannulation pancreatic guidewire technique eg double guidewire technique DGW precut sphincterotomy endoscopic papillectomy endoscopic ultrasound-guided rendezvous procedure and percutaneous transhepatic biliary drainage-guided procedure
Bile duct cannulation can be difficult because of different anatomical features inflammatory processes and adenomas of the papilla or periampullary diverticulum Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis
As the technique developed several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate
Commonly a precutting technique is used to allow biliary access when the standard cannulation technique failed There are types of precutting technique needle-knife papillotomy suprapapillary fistulotomy and trans pancreatic sphincterotomy in terms of effectiveness and efficiency of the precutting technique TPS which does not need avoiding pancreatic duct cannulation unintentionally is an effective method especially for difficult biliary cannulation
Also the use of a guidewire to physically occupy the pancreatic duct also known as the double guidewire technique this method has been used with promising results in cases of complex biliary cannulation especially in patients with a distorted BD anatomy caused by neoplasia or atypical morphology of the ampulla
Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures despite various accessory devices the standard biliary cannulation technique has been reported to fail in approximately 5-20 cases
Various endoscopic techniques for Selective Bile duct cannulation have been reported including standard techniques eg contrast injection technique wire-guided cannulation pancreatic guidewire technique eg double guidewire technique DGW precut sphincterotomy endoscopic papillectomy endoscopic ultrasound-guided rendezvous procedure and percutaneous transhepatic biliary drainage-guided procedure
Bile duct cannulation can be difficult because of different anatomical features inflammatory processes and adenomas of the papilla or periampullary diverticulum Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis
As the technique developed several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate
Commonly a precutting technique is used to allow biliary access when the standard cannulation technique failed There are types of precutting technique needle-knife papillotomy suprapapillary fistulotomy and trans pancreatic sphincterotomy in terms of effectiveness and efficiency of the precutting technique TPS which does not need avoiding pancreatic duct cannulation unintentionally is an effective method especially for difficult biliary cannulation
Also the use of a guidewire to physically occupy the pancreatic duct also known as the double guidewire technique this method has been used with promising results in cases of complex biliary cannulation especially in patients with a distorted BD anatomy caused by neoplasia or atypical morphology of the ampulla
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None