Kaffes Stent in the Management of Post-surgical Biliary Strictures

NCT03716232 | Unknown Phase 3 DMC

• 1 other identifier: HPB01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical success

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

  6 months after removal of stents

Secondary Outcomes (3)

• Technical success

  At time of procedure

• Stricture resolution at end of treatment

  After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group

• Occurrence of complications

  up to 6 months after the last procedure

Study Arms (2)

Multiple plastic stents

ACTIVE COMPARATOR

* 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

Metallic stent

EXPERIMENTAL

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

Interventions

Metallic stent DEVICE

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.

Metallic stent

Multiple plastic stents DEVICE

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.

Multiple plastic stents

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Theodor Bilharz Research Institute: collaborator
• National Hepatology & Tropical Medicine Research Institute: collaborator

Study Sites (3)

Kasr Alaini University Hospital

Cairo, New Cairo, 11771, Egypt

RECRUITING

National hepatology and tropical medicine research institute

Cairo, 11562, Egypt

RECRUITING

Theodor Bilharz Institute

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Cholangitis

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• hany shehab, FRCP

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany shehab, FRCP

CONTACT

+201111111071; h.shehab@kasralainy.edu.eg

Yasser eltabbakh, MD

CONTACT

+201001860999; yass.tabakh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 23, 2018
• Study Start: July 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

EG (3)