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Clinical Trials/NCT06631352
NCT06631352CompletedNot Applicable

Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy

Seoul National University Hospital0 sites50 target enrollmentStarted: January 1, 2000Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
5-year overall survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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. The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
  4. 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.
  5. 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who received hepatopancreatoduodenectomy between January 2000 and December 2023.

Exclusion Criteria

  • •Patients who had R2 resection

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Post operative complications(assessed up to 30 days from the surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Young Jang

Professor

Seoul National University Hospital

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