Hepatopancreaticobiliary (HPB) MalignancyHPD_singleNCT06631352
Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy
An observational study of Hepatopancreaticobiliary (HPB) Malignancy and Gall Bladder Cancer, run by Seoul National University Hospital.
Trial summary
1. In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure. 2. Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection. 3. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatopancreaticobiliary (HPB) Malignancy, Gall Bladder Cancer, Bile Duct Cancer
- What is being tested?
- Hepatopancreatoduodenectomy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 May 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included 51 patients who underwent HPD at Seoul National University Hospital between January 2000 and December 2023. One patient who had an R2 resection was excluded from the analysis.
Who may be able to join
- Patients who received hepatopancreatoduodenectomy between January 2000 and December 2023.
Who cannot join
- Patients who had R2 resection
About this study
- In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure.
- Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection.
- The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
- Over the past few decades, the understanding of the bile duct anatomy has significantly improved, and many methods have been developed to assess liver function and future remnant liver volume.
- We aimed to evaluate the short- and long-term outcomes of HPD and to assess risk factors associated with survival, early recurrence, and major complications to better evaluate the potential of the procedure as a standard treatment.
- Conditions
- Hepatopancreaticobiliary (HPB) Malignancy, Gall Bladder Cancer, Bile Duct Cancer, Pancreatoduodenectomy, Hepatectomy
- Being tested
- Hepatopancreatoduodenectomy
- Keywords
- Hepatopancreatoduodenectomy
- Medical subject headings
- Neoplasms, Gallbladder Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatopancreatoduodenectomyOther
Pancreatoduodenectomy with liver resection
| Study group | Role | What they receive |
|---|---|---|
| GB cancer | Patients who were diagnosed with gallbladder cancer and underwent the hepatopancreatoduodenectomy. Receives: Other: Hepatopancreatoduodenectomy | |
| CCA | Patients who were diagnosed with cholangiocarcinoma and underwent the hepatopancreatoduodenectomy. Receives: Other: Hepatopancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
the time from the date of surgery to the date of death or last follow-up.
Measured: assessed up to 60months
5-year disease-free survival
from the date of surgery to the first instance of recurrence, death, or last follow-up date.
Measured: assessed up to 60months
Secondary outcomes (1)
Post operative complications
Complications occured after the HPD. For example, there are post-hepatectomy liver failure, postoperative pancreatic fistula, ileus, fluid collection, pleural effusion, and etc.
Measured: assessed up to 30 days from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopancreaticobiliary (HPB) MalignancyStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631352
- Sponsor's protocol ID
- 2407-049-1551
- Acronym
- HPD_single
- Status last verified
- May 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT06631352
- Acronym / sponsor ID
- HPD_single / 2407-049-1551
- Conditions
- Hepatopancreaticobiliary (HPB) Malignancy, Gall Bladder Cancer, Bile Duct Cancer, Pancreatoduodenectomy, Hepatectomy
- Keywords
- Hepatopancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 8 Oct 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.
- In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure.
- Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection.
- The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
- Over the past few decades, the understanding of the bile duct anatomy has significantly improved, and many methods have been developed to assess liver function and future remnant liver volume.
- We aimed to evaluate the short- and long-term outcomes of HPD and to assess risk factors associated with survival, early recurrence, and major complications to better evaluate the potential of the procedure as a standard treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB cancer | – | Other: HepatopancreatoduodenectomyPatients who were diagnosed with gallbladder cancer and underwent the hepatopancreatoduodenectomy. |
| CCA | – | Other: HepatopancreatoduodenectomyPatients who were diagnosed with cholangiocarcinoma and underwent the hepatopancreatoduodenectomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 51 patients who underwent HPD at Seoul National University Hospital between January 2000 and December 2023. One patient who had an R2 resection was excluded from the analysis.
Key inclusion criteria (1 listed)
- Patients who received hepatopancreatoduodenectomy between January 2000 and December 2023.
Key exclusion criteria (1 listed)
- Patients who had R2 resection
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 |
|---|---|---|
| HepatopancreatoduodenectomyPancreatoduodenectomy with liver resection | Other | CCA, GB cancer |
Primary outcome
5-year overall survival
Time frame: assessed up to 60months
the time from the date of surgery to the date of death or last follow-up.
5-year disease-free survival
Time frame: assessed up to 60months
from the date of surgery to the first instance of recurrence, death, or last follow-up date.
1 secondary outcome
Post operative complications
Time frame: assessed up to 30 days from the surgery
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 8 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatopancreaticobiliary (HPB) Malignancy and Gall Bladder Cancer, run by Seoul National University Hospital.
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 1 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
5-year overall survival (time frame: assessed up to 60months). 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 8 Oct 2024.