Gallbladder CancerNCT02920554
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
A study testing wedge resection and bisegmentectomy in people with Gallbladder Cancer, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gallbladder Cancer
- What is being tested?
- wedge resection and bisegmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2 or T3 gallbladder cancer on preoperative CT exam
- Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
Who cannot join
- Peritoneal seeding or distant metastasis
- Impossible to resect the cancer radically
- Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
- R1 or R2 resection were pathologically diagnosed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kwang Yeol Paik, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
the Catholic University of Korea St. Vincent's Hospital
Suwon, 16247
About this study
Official title: The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.
Read the detailed description
The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.
Primary endpoint is recurrence-free-survival rates and overall survival rates.
- Conditions
- Gallbladder Cancer
- Being tested
- wedge resection, bisegmentectomy
- Keywords
- gallbladder cancer, bisegmentectomy
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wedge resectionProcedure or surgery
The extent of hepatic resection is wedge resection of liver including gallbladder fossa
bisegmentectomyProcedure or surgery
The extent of hepatic resection is 4b/5 bisegmentectomy of liver
| Study group | Role | What they receive |
|---|---|---|
| wedge resection | Active comparator | The extent of hepatic resection is wedge resection of gallbladder fossa Receives: Procedure: wedge resection |
| bisegmentectomy | Active comparator | The extent of hepatic resection is 4b/5 bisegmentectomy Receives: Procedure: bisegmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates
3year 5 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOU DONG DO, Saint Vincent's Hospital, Korea
- Investigators
- Dong Do You, MD, PhD, Study director, the Catholic Universityof Korea St. Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920554
- Sponsor's protocol ID
- XC14EIMI0009V
- Status last verified
- May 2024
- First submitted
- 28 Sep 2016
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02920554
- Acronym / sponsor ID
- XC14EIMI0009V
- Conditions
- Gallbladder Cancer
- Keywords
- gallbladder cancer, bisegmentectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Sep 2016 (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 extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.
Detailed description
The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.
Primary endpoint is recurrence-free-survival rates and overall survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wedge resection | Active comparator | Procedure: wedge resectionThe extent of hepatic resection is wedge resection of gallbladder fossa |
| bisegmentectomy | Active comparator | Procedure: bisegmentectomyThe extent of hepatic resection is 4b/5 bisegmentectomy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with T2 or T3 gallbladder cancer on preoperative CT exam
- Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
Key exclusion criteria (4 listed)
- Peritoneal seeding or distant metastasis
- Impossible to resect the cancer radically
- Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
- R1 or R2 resection were pathologically diagnosed.
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 |
|---|---|---|
| wedge resectionThe extent of hepatic resection is wedge resection of liver including gallbladder fossa | Procedure or surgery | wedge resection |
| bisegmentectomyThe extent of hepatic resection is 4b/5 bisegmentectomy of liver | Procedure or surgery | bisegmentectomy |
Primary outcome
Survival rates
Time frame: 1 year
3year 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Kwang Yeol Paik, MD, PhD contact
Dong Do You, MD, PhD study director
the Catholic Universityof Korea St. Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wedge resection and bisegmentectomy in people with Gallbladder Cancer, run by Saint Vincent's Hospital, Korea 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 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Do You, MD, PhD (82-31-249-8303, tzanggu@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rates (time frame: 1 year). 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 22 May 2024.