Kaffes Stent in the Management of Post-surgical Biliary Strictures

Status Recruiting

Clinical Trial Summary

Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures.

Metallic stents have the theoretical benefit of absence of need of multiple sessions.

These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem.

The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration.

This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03716232
Study type	Interventional
Source	Cairo University
Contact	hany shehab, FRCP
Phone	+201111111071
Email	h.shehab@kasralainy.edu.eg
Status	Recruiting
Phase	Phase 3
Start date	July 1, 2018
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03115411` - Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction	N/A
Completed	`NCT02041390` - Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases	N/A
Recruiting	`NCT01439698` - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	N/A
Terminated	`NCT01413386` - Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent	N/A
Completed	`NCT01543256` - WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study	N/A
Enrolling by invitation	`NCT04572711` - Prospective Evaluation of Biliary Tissue Sampling With ERCP
Recruiting	`NCT03229655` - Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation	N/A
Completed	`NCT02916199` - Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method	N/A
Recruiting	`NCT01524146` - Photodynamic Therapy (PDT) Cholangiocarcinoma Registry	N/A
Recruiting	`NCT01522573` - T-EUS for Gastrointestinal Disorders: A Multicenter Registry	N/A
Completed	`NCT02281019` - SpyGlass AMEA Registry
Recruiting	`NCT04010734` - Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures	N/A
Not yet recruiting	`NCT06369896` - Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
Recruiting	`NCT04391153` - FISH in Diagnosis of Biliary Stricture	N/A
Active, not recruiting	`NCT03997994` - DIGEST I Drug Coated Balloon for Biliary Stricture	N/A
Enrolling by invitation	`NCT03951324` - Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Unknown status	`NCT01085747` - Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis	N/A
Completed	`NCT02105181` - Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures	N/A
Recruiting	`NCT05761483` - Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
Completed	`NCT03673033` - Biliary Complications in Live Donor Liver Transplantation