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Kaffes Stent in the Management of Post-surgical Biliary Strictures

Primary Purpose

Benign Biliary Stricture, Biliary Stricture, Cholangitis

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Metallic stent
Multiple plastic stents
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Biliary Stricture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kasr Alaini University HospitalRecruiting
  • National hepatology and tropical medicine research instituteRecruiting
  • Theodor Bilharz InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Multiple plastic stents

Metallic stent

Arm 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.

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.

Outcomes

Primary Outcome Measures

Clinical success
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction

Secondary Outcome Measures

Technical success
Proportion of patients with Successful deployment of stents
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.
Occurrence of complications
occurence of any procedure-related complication

Full Information

First Posted
October 13, 2018
Last Updated
March 13, 2020
Sponsor
Cairo University
Collaborators
Theodor Bilharz Research Institute, National Hepatology & Tropical Medicine Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03716232
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Theodor Bilharz Research Institute, National Hepatology & Tropical Medicine Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Biliary Stricture, Biliary Stricture, Cholangitis, Bile Duct Stricture, Bile Duct Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiple plastic stents
Arm Type
Active Comparator
Arm 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.
Arm Title
Metallic stent
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Metallic stent
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Multiple plastic stents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical success
Description
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction
Time Frame
6 months after removal of stents
Secondary Outcome Measure Information:
Title
Technical success
Description
Proportion of patients with Successful deployment of stents
Time Frame
At time of procedure
Title
Stricture resolution at end of treatment
Description
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.
Time Frame
After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group
Title
Occurrence of complications
Description
occurence of any procedure-related complication
Time Frame
up to 6 months after the last procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany shehab, FRCP
Phone
+201111111071
Email
h.shehab@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser eltabbakh, MD
Phone
+201001860999
Email
yass.tabakh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany shehab, FRCP
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alaini University Hospital
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
11771
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany M shehab, MD
Email
h.shehab@kasralainy.edu.eg
Facility Name
National hepatology and tropical medicine research institute
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Elneklawy, MD
Phone
+201063300233
Email
mel_neklawi@hotmail.com
Facility Name
Theodor Bilharz Institute
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Elkady, MD
Phone
+201000053007
Email
dr.m.elkady@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Kaffes Stent in the Management of Post-surgical Biliary Strictures

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