Kaffes Stent in the Management of Post-surgical Biliary Strictures
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Clinical success [6 months after removal of stents]
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction
Secondary Outcome Measures
- Technical success [At time of procedure]
Proportion of patients with Successful deployment of stents
- 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]
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 [up to 6 months after the last procedure]
occurence of any procedure-related complication
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Alaini University Hospital | Cairo | New Cairo | Egypt | 11771 |
| 2 | National hepatology and tropical medicine research institute | Cairo | Egypt | 11562 | |
| 3 | Theodor Bilharz Institute | Cairo | Egypt | 11562 |
Sponsors and Collaborators
- Cairo University
- Theodor Bilharz Research Institute
- National Hepatology & Tropical Medicine Research Institute
Investigators
- Principal Investigator: hany shehab, FRCP, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HPB01