Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy

NCT06631352 | Completed

• 1 other identifier: 2407-049-1551
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure.
2. 2.Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection.
3. 3.The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
4. 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. 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.

Conditions

Hepatopancreaticobiliary (HPB) Malignancy; Gall Bladder Cancer; Bile Duct Cancer; Pancreatoduodenectomy; Hepatectomy

Keywords

Hepatopancreatoduodenectomy

Outcome Measures

Primary Outcomes (2)

• 5-year overall survival

  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

  from the date of surgery to the first instance of recurrence, death, or last follow-up date.

  assessed up to 60months

Secondary Outcomes (1)

• Post operative complications

  assessed up to 30 days from the surgery

Study Arms (2)

GB cancer

Patients who were diagnosed with gallbladder cancer and underwent the hepatopancreatoduodenectomy.

Other: Hepatopancreatoduodenectomy

CCA

Patients who were diagnosed with cholangiocarcinoma and underwent the hepatopancreatoduodenectomy.

Other: Hepatopancreatoduodenectomy

Interventions

Hepatopancreatoduodenectomy OTHER

Pancreatoduodenectomy with liver resection

CCA; GB cancer

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who had R2 resection

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Bile Duct Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2000
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-05