Clinical trial NCT03716232: Kaffes Stent in the Management of Post-surgical Biliary Strictures
Official title: The Safety and Efficacy of a Short Specially Designed Fully Covered Metallic Stent in the Management of Benign Post-surgical Biliary Strictures: a Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Benign Biliary Stricture
Biliary Stricture
Cholangitis
Bile Duct Stricture
Bile Duct Injury
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
name: National Hepatology & Tropical Medicine Research Institute
First posted: 2018-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical success
timeFrame: 6 months after removal of stents
Secondary outcomes:
measure: Technical success
timeFrame: At time of procedure
measure: Stricture resolution at end of treatment
timeFrame: After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group
measure: Occurrence of complications
timeFrame: up to 6 months after the last procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini University Hospital
state: New Cairo
city: Cairo
country: Egypt
facility: National hepatology and tropical medicine research institute
city: Cairo
country: Egypt
facility: Theodor Bilharz Institute
Study officials:
affiliation: Cairo University
name: hany shehab, FRCP
role: PRINCIPAL_INVESTIGATOR
References: