Kaffes Stent in the Management of Post-surgical Biliary Strictures

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Cholangitis; Bile Duct Injury; Biliary Stricture; Bile Duct Stricture; Benign Biliary Stricture

Treatments: Device: Metallic stent; Device: Multiple plastic stents

Study type: Interventional

Funder types: Other

Identifiers

NCT03716232

HPB01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Multiple plastic stents

Active Comparator group

Description:

* 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.

Treatment:

Device: Multiple plastic stents

Metallic stent

Experimental group

Description:

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.

Treatment:

Device: Metallic stent