Cholangiocellular CarcinomaPhase 2NCT01320241
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
A Phase 2 study testing self-expandable 125I radioactive seeds-loaded-stent and self-expandable biliary nitinol alloys stent in people with Cholangiocellular Carcinoma and Pancreatic Cancer, run by Southeast University, China at 1 site in China.
Trial summary
Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocellular Carcinoma, Pancreatic Cancer, Gallbladder Cancer
- What is being tested?
- self-expandable 125I radioactive seeds-loaded-stent and self-expandable biliary nitinol alloys stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Mar 2012
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or older
- Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
- Clinical symptoms of biliary obstruction
- Unresectable or refused to be surgically treated biliary obstruction by any malignant process
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Who cannot join
- Suspected benign bile duct stricture
- Strictures that can not be dilated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence metallic biliary stent or bile duct surgery
- Patients for whom PTC procedures are contraindicated
- Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
- Noncooperation or no authorization and signature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture
Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.
- Being tested
- self-expandable 125I radioactive seeds-loaded-stent, self-expandable biliary nitinol alloys stent
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Gallbladder Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-expandable 125I radioactive seeds-loaded-stentDevice
Also called irradiation biliary stent
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
self-expandable biliary nitinol alloys stentDevice
Also called conventional SEMS
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
| Study group | Role | What they receive |
|---|---|---|
| novel radiation stent | Active comparator | Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1.
Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent Receives: Device: self-expandable 125I radioactive seeds-loaded-stent |
| conventional stent | Experimental | Patients undergo placement of a conventional nitinol SEMS on day1.
Intervention: Device: self-expandable biliary nitinol alloys stent Receives: Device: self-expandable biliary nitinol alloys stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Survival and Median Survival
Measured: follow-up in interval of stent insertion and death (3 years)
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure.
Measured: follow-up in interval of stent insertion and death (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startNov 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocellular CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-Jun Teng, Southeast University, China
- Investigators
- Gao-jun Teng, MD, PhD, Principal investigator, Zhong-Da Hospital, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320241
- Sponsor's protocol ID
- 320924197612177170-BS
- Status last verified
- Mar 2011
- First submitted
- 21 Mar 2011
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture
- ClinicalTrials.gov ID
- NCT01320241
- Acronym / sponsor ID
- 320924197612177170-BS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Mar 2011 (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.
Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with 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 |
|---|---|---|
| novel radiation stent | Active comparator | Device: self-expandable 125I radioactive seeds-loaded-stentPatients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent |
| conventional stent | Experimental | Device: self-expandable biliary nitinol alloys stentPatients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years old or older
- Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
- Clinical symptoms of biliary obstruction
- Unresectable or refused to be surgically treated biliary obstruction by any malignant process
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Suspected benign bile duct stricture
- Strictures that can not be dilated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence metallic biliary stent or bile duct surgery
- Patients for whom PTC procedures are contraindicated
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 |
|---|---|---|
| self-expandable 125I radioactive seeds-loaded-stentAlso: irradiation biliary stentPatients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1. | Device | novel radiation stent |
| self-expandable biliary nitinol alloys stentAlso: conventional SEMSPatients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1. | Device | conventional stent |
Primary outcome
Overall Mean Survival and Median Survival
Time frame: follow-up in interval of stent insertion and death (3 years)
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure.
Time frame: follow-up in interval of stent insertion and death (3 years)
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 2 Apr 2012.
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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.
Gao-jun Teng, MD, PhD principal investigator
Zhong-Da Hospital, Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing self-expandable 125I radioactive seeds-loaded-stent and self-expandable biliary nitinol alloys stent in people with Cholangiocellular Carcinoma and Pancreatic Cancer, run by Southeast University, China at 1 site in China.
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 7 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 2 Apr 2012. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall Mean Survival and Median Survival (time frame: follow-up in interval of stent insertion and death (3 years)). 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 2 Apr 2012.