Biliary Tract CancerNCT06222619
Effect of PVE on Surgical Outcomes and Long-term Survival in Perihilar Cholangiocarcinoma
An observational study of Biliary Tract Cancer and Portal Vein Embolization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Tract Cancer, Portal Vein Embolization
- What is being tested?
- Potal vein embilization
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2020to 30 Aug 2023
- 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: Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma
Who may be able to join
- patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
- patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.
Who cannot join
- patients with unresectable perihilar cholangiocarcinoma
- patients who refused treatment
- patients with other concomitant malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Portal Vein Embolization on Surgical Outcomes and Long-term Survival in Patients With Perihilar Cholangiocarcinoma
Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV.
- Conditions
- Biliary Tract Cancer, Portal Vein Embolization
- Being tested
- Potal vein embilization
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potal vein embilizationProcedure or surgery
Also called Surgical resection
Portal vein of involved bile duct is embolized to increase the volume of remnant liver.
| Study group | Role | What they receive |
|---|---|---|
| Resection without PVE | Resection of bile duct and associated hemi-liver without portal vein embilzation | |
| Resection after PVE | Resection of bile duct and associated hemi-liver after portal vein embilzation Receives: Procedure: Potal vein embilization | |
| No resection after PVE | No resection of bile duct and associated hemi-liver after portal vein embilzation Receives: Procedure: Potal vein embilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival of each group (A-C).
Measured: The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months
Secondary outcomes (1)
Recurrence free survival
Recurrence free survival of patients who underwent surgical resection
Measured: The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start30 Jan 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2023
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.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222619
- Sponsor's protocol ID
- H-2001-092-1095
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Portal Vein Embolization on Surgical Outcomes and Long-term Survival in Patients With Perihilar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06222619
- Acronym / sponsor ID
- H-2001-092-1095
- Conditions
- Biliary Tract Cancer, Portal Vein Embolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 25 Jan 2024 (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.
Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resection without PVE | – | –Resection of bile duct and associated hemi-liver without portal vein embilzation |
| Resection after PVE | – | Procedure: Potal vein embilizationResection of bile duct and associated hemi-liver after portal vein embilzation |
| No resection after PVE | – | Procedure: Potal vein embilizationNo resection of bile duct and associated hemi-liver after portal vein embilzation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma
Key inclusion criteria (2 listed)
- patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
- patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.
Key exclusion criteria (3 listed)
- patients with unresectable perihilar cholangiocarcinoma
- patients who refused treatment
- patients with other concomitant malignancies.
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 |
|---|---|---|
| Potal vein embilizationAlso: Surgical resectionPortal vein of involved bile duct is embolized to increase the volume of remnant liver. | Procedure or surgery | No resection after PVE, Resection after PVE |
Primary outcome
Overall survival
Time frame: The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months
Overall survival of each group (A-C).
1 secondary outcome
Recurrence free survival
Time frame: The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months
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 25 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Portal Vein Embolization, run by Seoul National University Hospital at 1 site 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 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: finished, as of the sponsor's last update on 25 Jan 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 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?
Overall survival (time frame: The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months). 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 25 Jan 2024.