Malignant Biliary ObstructionNCT05786326
Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction
A study testing group 1, group 2 and group 3 in people with Malignant Biliary Obstruction, run by Zagazig University at 1 site in Egypt.
Trial summary
multiholes fully covered metallic stents in the management of malignant biliary obstruction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- group 1, group 2 and group 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2023to 1 Jul 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of malignant obstructive jaundice.
- Patient not eligible for surgery.
- Age above 18 years, any gender.
Who cannot join
- Benign obstructive jaundice.
- Patient eligible for surgery.
- Failure to stent insertion.
- Patient not fit for ERCP and/or anaesthesia.
- Surgical and anatomical abnormalities interfere with endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Multi Holes Fully Covered Metallic Stents Versus Uncovered and Partially Covered Metallic Stents in the Management of Malignant Biliary Obstruction: Randomized Parallel Clinical Trial.
multiholes fully covered metallic stents in the management of malignant biliary obstruction
Read the detailed description
Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.
Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.
Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane
- Conditions
- Malignant Biliary Obstruction
- Being tested
- group 1, group 2, group 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1Device
Also called multiholes fully covered metallic stent
Insertion of fully covered self-expanding metallic stents with multi-holes (FCSEMS- MH) Biliary stent HANAROSTENT® CCC (M.I.Tech Co., Ltd, pyeongtaek, Korea) in a biliary tree through endoscopic retrograde cholangiopancreatography (ERCP) under general anesthesia by expertise in patients with malignant biliary obstruction
group 2Device
Also called partially covered metallic stents
Insertion of partially covered self-expanding metallic stents HANAROSTENT® Biliary (NCN) in the biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction.
group 3Device
Also called uncovered metallic stents
Insertion of uncovered self-expanding metallic stents (Biliary stent HANAROSTENT® NNN) (M.I.Tech Co., Ltd. Pyeongtaek, Korea) in a biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction.
| Study group | Role | What they receive |
|---|---|---|
| multiholes fully covered metaalic stents group | Experimental | Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction. Receives: Device: group 1 |
| parially covered metallic stents group | Active comparator | Insertion of partially covered metallic stents in patients with malignant biliary obstruction. Receives: Device: group 2 |
| unocoered metaalic stents group | Active comparator | Insertion of uncovered metallic stents in patients with malignant biliary obstruction. Receives: Device: group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction
Detect the stent in his place. Patients clinically improved, and bilirubin decrease or reach normal values.
Measured: at 3 and 6 months follow up after stents ineration
Secondary outcomes (1)
Stent dysfunction (obstruction or migration)
detect the stents dysfunction either obstruction or migration by clinical examination and abdominal ultrasound
Measured: after 3 and 6 months from stents insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start28 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, H Abdelkader, Zagazig University
- Investigators
- Mohamed I Magdy, profeesor, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786326
- Sponsor's protocol ID
- ZU-IRB #10426/1-3-2023
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Multi Holes Fully Covered Metallic Stents Versus Uncovered and Partially Covered Metallic Stents in the Management of Malignant Biliary Obstruction: Randomized Parallel Clinical Trial.
- ClinicalTrials.gov ID
- NCT05786326
- Acronym / sponsor ID
- ZU-IRB #10426/1-3-2023
- Conditions
- Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 27 Mar 2023 (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.
multiholes fully covered metallic stents in the management of malignant biliary obstruction
Detailed description
Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.
Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.
Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiholes fully covered metaalic stents group | Experimental | Device: group 1Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction. |
| parially covered metallic stents group | Active comparator | Device: group 2Insertion of partially covered metallic stents in patients with malignant biliary obstruction. |
| unocoered metaalic stents group | Active comparator | Device: group 3Insertion of uncovered metallic stents in patients with malignant biliary obstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of malignant obstructive jaundice.
- Patient not eligible for surgery.
- Age above 18 years, any gender.
Key exclusion criteria (5 listed)
- Benign obstructive jaundice.
- Patient eligible for surgery.
- Failure to stent insertion.
- Patient not fit for ERCP and/or anaesthesia.
- Surgical and anatomical abnormalities interfere with endoscopy.
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 |
|---|---|---|
| group 1Also: multiholes fully covered metallic stentInsertion of fully covered self-expanding metallic stents with multi-holes (FCSEMS- MH) Biliary stent HANAROSTENT® CCC (M.I.Tech Co., Ltd, pyeongtaek, Korea) in a biliary tree through endoscopic retrograde cholangiopancreatography (ERCP) under general anesthesia by expertise in patients with malignant biliary obstruction | Device | multiholes fully covered metaalic stents group |
| group 2Also: partially covered metallic stentsInsertion of partially covered self-expanding metallic stents HANAROSTENT® Biliary (NCN) in the biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction. | Device | parially covered metallic stents group |
| group 3Also: uncovered metallic stentsInsertion of uncovered self-expanding metallic stents (Biliary stent HANAROSTENT® NNN) (M.I.Tech Co., Ltd. Pyeongtaek, Korea) in a biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction. | Device | unocoered metaalic stents group |
Primary outcome
Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction
Time frame: at 3 and 6 months follow up after stents ineration
Detect the stent in his place. Patients clinically improved, and bilirubin decrease or reach normal values.
1 secondary outcome
Stent dysfunction (obstruction or migration)
Time frame: after 3 and 6 months from stents insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed I Magdy, profeesor study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 1, group 2 and group 3 in people with Malignant Biliary Obstruction, run by Zagazig University at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction (time frame: at 3 and 6 months follow up after stents ineration). 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 24 Jul 2024.