Unresectable Hilar CholangiocarcinomaPhase 4NCT00746538
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent
A Phase 4 study testing biliary stent in people with Unresectable Hilar Cholangiocarcinoma, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hilar Cholangiocarcinoma
- What is being tested?
- biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2008to Jul 2009
- Phase
- Phase 4
- 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
- All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
- Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
Who cannot join
- Patient with ASA 4 or 5
- Patient who inability to comply with follow up
- Patient refused to join the research
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Srinagarind Hospital.KhonKaen University.
Muang, KhonKaen
Worrarat Kongkasame, MD
About this study
Official title: Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.
Read the detailed description
In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
There are two types of biliary stent:
- plastic stent made from polyethylene or polytetrafluoroethylene
- metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.
- Conditions
- Unresectable Hilar Cholangiocarcinoma
- Being tested
- biliary stent
- Keywords
- Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary stentDevice
Also called Self expandable metallic stent, Amsterdam type plastic stent
Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metallic stent group Receives: Device: biliary stent |
| 2 | Active comparator | plastic stent group Receives: Device: biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
Measured: 2-4 weeks
Secondary outcomes (2)
To assessment of early and late complication after palliative stent.
Measured: After stent insertion for sixth month and one year or until patients were expired
Survival rate at sixth month and one year.
Measured: After stent insertion for sixth month and one year or until patients were expired
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009 (estimated)
- Study completionJul 2009 (estimated)
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 Unresectable Hilar CholangiocarcinomaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Worrarat Kongkasame, MD, Principal investigator, Department of Medicine.Faculty of Medicine .KhonKaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746538
- Sponsor's protocol ID
- HE500636(subproject)
- Other IDs
- HE5OO636(sub)
- Status last verified
- Jul 2008
- First submitted
- 3 Sep 2008
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310.
PubMed 12838220
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00746538
- Acronym / sponsor ID
- HE500636(subproject)
- Conditions
- Unresectable Hilar Cholangiocarcinoma
- Keywords
- Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Sep 2008 (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 quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.
Detailed description
In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
There are two types of biliary stent:
- plastic stent made from polyethylene or polytetrafluoroethylene
- metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: biliary stentmetallic stent group |
| 2 | Active comparator | Device: biliary stentplastic stent group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
- Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
Key exclusion criteria (3 listed)
- Patient with ASA 4 or 5
- Patient who inability to comply with follow up
- Patient refused to join the research
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 |
|---|---|---|
| biliary stentAlso: Self expandable metallic stent, Amsterdam type plastic stentMetallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP | Device | 1, 2 |
Primary outcome
To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
Time frame: 2-4 weeks
2 secondary outcomes
To assessment of early and late complication after palliative stent.
Time frame: After stent insertion for sixth month and one year or until patients were expired
Survival rate at sixth month and one year.
Time frame: After stent insertion for sixth month and one year or until patients were expired
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2008.
- Results publication: PubMed 12838220De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310.
- Research affairs.Faculty of Medicine.KhonKaen UniversityLink provided by the sponsor.
Related trials for Unresectable Hilar Cholangiocarcinoma
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Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Perihilar Cholangiocarcinoma, Klatskin Tumor
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Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Cholangiocarcinoma, Hilar Cholangiocarcinoma
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Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
Cholangiocarcinoma, Klatskin Tumor
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HCCANANO-HOPE1: IRE After Chemotherapy for Locally Advanced Unresectable Perihilar Cholangiocarcinoma
IRE
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.
Worrarat Kongkasame, MD principal investigator
Department of Medicine.Faculty of Medicine .KhonKaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biliary stent in people with Unresectable Hilar Cholangiocarcinoma, run by Khon Kaen University at 1 site in Thailand.
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 2 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 4 Sep 2008. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Worrarat Kongkasame, MD ((66)0817259376, worrarat-eab@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. (time frame: 2-4 weeks). 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 NCT00746538, 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 4 Sep 2008.