Biliary NeoplasmsNCT02460432
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
A study testing Paclitaxel-eluting metal Stent and Covered Metal Stent in people with Biliary Neoplasms and Biliary Obstruction, run by Taewoong Medical Co., Ltd. at 5 sites in South Korea.
Trial summary
The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
- What is being tested?
- Paclitaxel-eluting metal Stent and Covered Metal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesSouth Korea
- Study dates
- May 2015to 26 Dec 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 19 years of age
- Malignant mid or distal biliary obstruction
- Unresectable cancer
- Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
- Patient willing to provide written informed consent and comply with follow-up requirements
Who cannot join
- Patients who had undergone surgical biliary drainage
- Severe bleeding disorder (e.g. coagulopathy)
- Polypoid lesion or intra-abdominal abscess
- Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Inje University Busan Paik Hospital
Busan, Bokji-ro Busanjin-gu, 633-165
In Ha University Hospital
Incheon, Inhang-ro Jung-gu, 400-711
Seoul National University Hospital
Seoul, Haehak-ro Jongno-gu, 110-744
Samsung Medical Center
Seoul, Irwon-Dong, Gangnam-Gu, 130-710
Gangnam Severance Hospital
Seoul, 135-720
About this study
Official title: A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction
The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.
Read the detailed description
In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.
- Conditions
- Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
- Being tested
- Paclitaxel-eluting metal Stent, Covered Metal Stent
- Keywords
- Drug-eluting Biliary stent, Covered metalic stent
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-eluting metal StentDevice
Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP
Covered Metal StentDevice
Insertion of ComVi Biliary Covered Stent using ERCP
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-eluting metal Stent | Experimental | Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Paclitaxel-eluting metal Stent |
| Covered Metal Stent | Active comparator | ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Covered Metal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative stent patency during 6months after stent placement
Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.
Measured: 6 month
Secondary outcomes (4)
Stent migration
Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.
Measured: 6 month
Secondary stent insertion due to recurrent biliary obstruction
Measured: 6 month
Mean survival
Measured: 6 month
Adverse events
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion26 Dec 2016
- Study completion26 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary NeoplasmsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Ki Lee, Ph.D MD, Study chair, Gangnam Severance HospitalKyu Taek Lee, Ph.D MD, Principal investigator, Samsung Medical CenterSang Hyub Lee, Ph.D MD, Principal investigator, Seoul National University HospitalDon Haeng Lee, Ph.D MD, Principal investigator, In Ha University HospitalJung Sik Choi, Ph.D MD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460432
- Sponsor's protocol ID
- MIRA-003
- Status last verified
- Apr 2017
- First submitted
- 26 May 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: February 12, 2016
Publications
Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.
PubMed 30414164
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT02460432
- Acronym / sponsor ID
- MIRA-003
- Conditions
- Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
- Keywords
- Drug-eluting Biliary stent, Covered metalic stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 26 Dec 2016 (actual)
- Study completion
- 26 Dec 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.
Detailed description
In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-eluting metal Stent | Experimental | Device: Paclitaxel-eluting metal StentNiti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea) |
| Covered Metal Stent | Active comparator | Device: Covered Metal StentComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 19 years of age
- Malignant mid or distal biliary obstruction
- Unresectable cancer
- Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
- Patient willing to provide written informed consent and comply with follow-up requirements
Key exclusion criteria (4 listed)
- Patients who had undergone surgical biliary drainage
- Severe bleeding disorder (e.g. coagulopathy)
- Polypoid lesion or intra-abdominal abscess
- Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
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 |
|---|---|---|
| Paclitaxel-eluting metal StentInsertion of Niti-S Mira-Cover III Biliary Stent using ERCP | Device | Paclitaxel-eluting metal Stent |
| Covered Metal StentInsertion of ComVi Biliary Covered Stent using ERCP | Device | Covered Metal Stent |
Primary outcome
Cumulative stent patency during 6months after stent placement
Time frame: 6 month
Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.
4 secondary outcomes
Stent migration
Time frame: 6 month
Secondary stent insertion due to recurrent biliary obstruction
Time frame: 6 month
Mean survival
Time frame: 6 month
Adverse events
Time frame: 6 month
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 11 Apr 2017.
- Derived from this study: PubMed 30414164Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.
- Individual participant dataSharing planned: Yes. February 12, 2016
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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.
Dong Ki Lee, Ph.D MD study chair
Gangnam Severance Hospital
Kyu Taek Lee, Ph.D MD principal investigator
Samsung Medical Center
Sang Hyub Lee, Ph.D MD principal investigator
Seoul National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-eluting metal Stent and Covered Metal Stent in people with Biliary Neoplasms and Biliary Obstruction, run by Taewoong Medical Co., Ltd. at 5 sites in South Korea.
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 5 inclusion and 4 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Cumulative stent patency during 6months after stent placement (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460432, which also lists 1 linked publication.
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 11 Apr 2017.