Kaffes Stent in the Management of Post-surgical Biliary Strictures

Biliary Stricture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716232
• Other study ID #: HPB01
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: hany shehab, FRCP
• Phone: +201111111071
• Email: h.shehab[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Biliary Stricture
• Bile Duct Injury
• Bile Duct Stricture
• Biliary Stricture
• Cholangitis
• Cholestasis
• Constriction, Pathologic

Intervention

Device:
• 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.
• Multiple plastic stents
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.

Locations

Country	Name	City	State
Egypt	Kasr Alaini University Hospital	Cairo	New Cairo
Egypt	National hepatology and tropical medicine research institute	Cairo
Egypt	Theodor Bilharz Institute	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	National Hepatology & Tropical Medicine Research Institute, Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction	6 months after removal of stents
Secondary	Technical success	Proportion of patients with Successful deployment of stents	At time of procedure
Secondary	Stricture resolution at end of treatment	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.	After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group
Secondary	Occurrence of complications	occurence of any procedure-related complication	up to 6 months after the last procedure