Biliary Tract CancerNCT01861483
Vessel Resection and Reconstruction of Biliary Tract Cancers
An observational study of Biliary Tract Cancer, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
Trial summary
To investigate the vessel resection and reconstruction in biliary tract cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Tract Cancer
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Mar 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent vessel resection and reconstruction in biliary tract cancer after 1990 will be included for analysis.
Who may be able to join
- Cases of vessel resection and reconstruction in biliary tract cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka University, Graduate School of Medicine
Osaka, Osaka, 565-0871
About this study
Official title: Resection and Reconstruction of Major Vessels in Biliary Tract Cancers
To investigate the vessel resection and reconstruction in biliary tract cancer.
Read the detailed description
The vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. In this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.
- Conditions
- Biliary Tract Cancer
- Medical subject headings
- Biliary Tract Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of vascular invasion in diagnostic image and in pathology.
Measured: 20 years
R0 resection rate
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansai Hepatobiliary Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hiroaki Nagano, MD, PhD, Study director, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861483
- Sponsor's protocol ID
- KHBO1205
- Other IDs
- UMIN000010415
- Status last verified
- Jun 2014
- First submitted
- 14 May 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection and Reconstruction of Major Vessels in Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT01861483
- Acronym / sponsor ID
- KHBO1205
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kansai Hepatobiliary Oncology GroupResearch network
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 May 2013 (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.
To investigate the vessel resection and reconstruction in biliary tract cancer.
Detailed description
The vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. In this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent vessel resection and reconstruction in biliary tract cancer after 1990 will be included for analysis.
Key inclusion criteria (1 listed)
- Cases of vessel resection and reconstruction in biliary tract cancer.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of vascular invasion in diagnostic image and in pathology.
Time frame: 20 years
R0 resection rate
Time frame: 20 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 1 Jul 2014.
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Active, not recruitingPhase 2/3
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Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
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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.
Hiroaki Nagano, MD, PhD study director
Osaka University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
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 1 inclusion and 0 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 1 Jul 2014. 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 Japan. 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?
Comparison of vascular invasion in diagnostic image and in pathology. (time frame: 20 years). The study lists 2 primary outcomes in all. 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 1 Jul 2014.