Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy (HPD_single)

October 6, 2024 updated by: Jin-Young Jang, Seoul National University Hospital
  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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who had R2 resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GB cancer
Patients who were diagnosed with gallbladder cancer and underwent the hepatopancreatoduodenectomy.
Other: Hepatopancreatoduodenectomy
Pancreatoduodenectomy with liver resection
CCA
Patients who were diagnosed with cholangiocarcinoma and underwent the hepatopancreatoduodenectomy.
Other: Hepatopancreatoduodenectomy
Pancreatoduodenectomy with liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
assessed up to 60months
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.
assessed up to 60months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative complications
Time Frame: assessed up to 30 days from the surgery
Complications occured after the HPD. For example, there are post-hepatectomy liver failure, postoperative pancreatic fistula, ileus, fluid collection, pleural effusion, and etc.
assessed up to 30 days from the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2407-049-1551

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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