Kaffes Stent in the Management of Post-surgical Biliary Strictures

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

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.

Study Overview

• Status: Unknown
• Conditions: Cholangitis; Biliary Stricture; Bile Duct Injury; Bile Duct Stricture; Benign Biliary Stricture
• Intervention / Treatment: Device: Multiple plastic stents; Device: Metallic stent

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • National Hepatology and Tropical Medicine Research Institute
    • Contact: Mohamed Elneklawy, MD; Phone Number: +201063300233; Email: mel_neklawi@hotmail.com
  • Cairo, Egypt, 11562
    • Recruiting
    • Theodor Bilharz Institute
    • Contact: Mohamed Elkady, MD; Phone Number: +201000053007; Email: dr.m.elkady@gmail.com
  • New Cairo
    • Cairo, New Cairo, Egypt, 11771
      • Recruiting
      • Kasr Alaini University Hospital
      • Contact: hany M shehab, MD; Email: h.shehab@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction	6 months after removal of stents

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Proportion of patients with Successful deployment of stents	At time of procedure
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
Occurrence of complications	occurence of any procedure-related complication	up to 6 months after the last procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Theodor Bilharz Research Institute; National Hepatology & Tropical Medicine Research Institute
• Investigators: Principal Investigator: hany shehab, FRCP, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: October 20, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholangitis; Cholestasis
• Other Study ID Numbers: HPB01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No