Kaffes Stent in the Management of Post-surgical Biliary Strictures

Phase 3

• Conditions: Benign Biliary Stricture; Cholangitis; Bile Duct Injury; Bile Duct Stricture; Biliary Stricture
• Interventions: Device: Multiple plastic stents; Device: Metallic stent

• Registration Number: NCT03716232
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-10-13
• Study First Submitted QC: 2018-10-20
• Study First Posted: 2018-10-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmed benign postsurgical biliary stricture by presence of all 3 of the following:

Ultrasound imaging or Magnetic resonance cholangiopancreatography (MRCP) showing biliary dilatation, Raised bilirubin and or alkaline phosphatase, History of biliary tree surgery within the previous year

• Naïve to endoscopic therapy
• Age > 18 years

Read More

Exclusion Criteria

• Coagulopathy
• Inability of patient to adhere to regular follow-up
• Living-donor liver transplant patients

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple plastic stents	Multiple plastic stents	* All procedures will be performed under propofol sedation. Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 10 French plastic stent will be inserted bypassing the level of the stricture. * Stent replacement and the addition of further stents will be planned after 3 months from the initial procedure and every 3 months until stricture resolution occurs with a maximum of four procedures. Balloon dilatation with a 6-10 mm balloon will be used in each session before stent insertion.
Metallic stent	Metallic stent	All procedures will be performed under propofol sedation. Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 4-6cm fully covered expandable metallic stent (Kaffes stent, Taewoong medical, Seoul, Korea) will then be deployed at the level of the stricture. In cases close to the hepatic hilum where the deployment of the stent is expected to reach one duct and possibly block another duct, a 7 Fr stent will be inserted prior to deployment of the metallic stent in the contralateral duct.. - Stent will be extracted endoscopically after 6 months.

Primary Outcome Measures

Name	Time	Method
Clinical success	6 months after removal of stents	Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction

Secondary Outcome Measures

Name	Time	Method
Technical success	At time of procedure	Proportion of patients with Successful deployment of stents
Stricture resolution at end of treatment	After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group	Radiological resolution of the stricture at the time of removal of the stents (after insertion of 3 or 4 stents) and after removal of the metallic stent.
Occurrence of complications	up to 6 months after the last procedure	occurence of any procedure-related complication

Trial Locations

Locations (3)

National hepatology and tropical medicine research institute; 🇪🇬 Cairo, Egypt

Theodor Bilharz Institute; 🇪🇬 Cairo, Egypt

Kasr Alaini University Hospital; 🇪🇬 Cairo, New Cairo, Egypt