Benign Biliary StricturePhase 3NCT03716232
Kaffes Stent in the Management of Post-surgical Biliary Strictures
A Phase 3 study testing Metallic stent and Multiple plastic stents in people with Benign Biliary Stricture and Biliary Stricture, run by Cairo University at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Biliary Stricture, Biliary Stricture, Cholangitis
- What is being tested?
- Metallic stent and Multiple plastic stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Coagulopathy
- Inability of patient to adhere to regular follow-up
- Living-donor liver transplant patients
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Kasr Alaini University Hospital
Cairo, New Cairo, 11771
hany M shehab, MD, h.shehab@kasralainy.edu.eg
- Recruiting
National hepatology and tropical medicine research institute
Cairo, 11562
Mohamed Elneklawy, MD, +201063300233, mel_neklawi@hotmail.com
- Recruiting
Theodor Bilharz Institute
Cairo, 11562
Mohamed Elkady, MD, +201000053007, dr.m.elkady@gmail.com
About this study
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
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.
Read more
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
- Being tested
- Metallic stent, Multiple plastic stents
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metallic stentDevice
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.
Multiple plastic stentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction
Measured: 6 months after removal of stents
Secondary outcomes (3)
Technical success
Proportion of patients with Successful deployment of stents
Measured: 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.
Measured: 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
Measured: up to 6 months after the last procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Theodor Bilharz Research Institute, National Hepatology & Tropical Medicine Research Institute
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
- Investigators
- hany shehab, FRCP, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716232
- Sponsor's protocol ID
- HPB01
- Status last verified
- Mar 2020
- First submitted
- 13 Oct 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03716232
- Acronym / sponsor ID
- HPB01
- Conditions
- Benign Biliary Stricture, Biliary Stricture, Cholangitis, Bile Duct Stricture, Bile Duct Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute, National Hepatology & Tropical Medicine Research Institute
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple plastic stents | Active comparator | Device: 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. |
| Metallic stent | Experimental | Device: Metallic stentAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Coagulopathy
- Inability of patient to adhere to regular follow-up
- Living-donor liver transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metallic stentAll 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 |
| Multiple plastic stentsStrictures 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 |
Primary outcome
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
3 secondary outcomes
Technical success
Time frame: At time of procedure
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
Occurrence of complications
Time frame: up to 6 months after the last procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hany shehab, FRCP principal investigator
Cairo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metallic stent and Multiple plastic stents in people with Benign Biliary Stricture and Biliary Stricture, run by Cairo University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany shehab, FRCP (+201111111071, h.shehab@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 6 months after removal of stents). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.