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OpenTrials
Completed

NCT Number: NCT06631352

Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who had R2 resection

Treatment and study plan

Hepatopancreatoduodenectomy

Other

Pancreatoduodenectomy with liver resection

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: HPD_single

Important dates

Study start
2000
Primary completion
2023
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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