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Kaffes Stent in the Management of Post-surgical Biliary Strictures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716232
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Theodor Bilharz Research Institute
National Hepatology & Tropical Medicine Research Institute
Information provided by (Responsible Party):
Hany Shehab, Cairo University

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.


Condition or disease Intervention/treatment Phase
Benign Biliary Stricture Biliary Stricture Cholangitis Bile Duct Stricture Bile Duct Injury Device: Metallic stent Device: Multiple plastic stents Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

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.





Primary Outcome Measures :
  1. Clinical success [ Time Frame: 6 months after removal of stents ]
    Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction


Secondary Outcome Measures :
  1. Technical success [ Time Frame: At time of procedure ]
    Proportion of patients with Successful deployment of stents

  2. Stricture resolution at end of treatment [ Time Frame: After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group ]
    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.

  3. Occurrence of complications [ Time Frame: up to 6 months after the last procedure ]
    occurence of any procedure-related complication



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716232


Contacts
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Contact: hany shehab, FRCP +201111111071 h.shehab@kasralainy.edu.eg
Contact: Yasser eltabbakh, MD +201001860999 yass.tabakh@gmail.com

Locations
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Egypt
Kasr Alaini University Hospital Recruiting
Cairo, New Cairo, Egypt, 11771
Contact: hany M shehab, MD       h.shehab@kasralainy.edu.eg   
National hepatology and tropical medicine research institute Recruiting
Cairo, Egypt, 11562
Contact: Mohamed Elneklawy, MD    +201063300233    mel_neklawi@hotmail.com   
Theodor Bilharz Institute Recruiting
Cairo, Egypt, 11562
Contact: Mohamed Elkady, MD    +201000053007    dr.m.elkady@gmail.com   
Sponsors and Collaborators
Cairo University
Theodor Bilharz Research Institute
National Hepatology & Tropical Medicine Research Institute
Investigators
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Principal Investigator: hany shehab, FRCP Cairo University

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Responsible Party: Hany Shehab, Associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT03716232    
Other Study ID Numbers: HPB01
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholestasis
Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics