Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy

Completed

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

• Registration Number: NCT06631352
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-05
• Study Completion: 2024-05-31
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-06
• Last Update Submitted: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Patients who had R2 resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year overall survival	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	assessed up to 60months	from the date of surgery to the first instance of recurrence, death, or last follow-up date.

Secondary Outcome Measures

Name	Time	Method
Post operative complications	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.