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NCT Number: NCT05402618

Minimally Invasive Versus Open Surgery for PHC

Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.

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Key information

Conditions

Perihilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Histologically confirmed PHC.

Exclusion criteria

  • Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
  • Non-adenocarcinoma histology;
  • Incomplete clinical data.

Treatment and study plan

No intervention

Other

This is an observational study without any intervention.

Primary outcomes

  1. Postoperative length of stay

    Time frame: up to 90 days

    defined as the time from being admitted to hospital to discharge

  2. Overall survival

    Time frame: through study completion, an average of 5 year

    defined as the duration from the first day after surgery to either the date of death or the last follow-up

Secondary outcomes

  1. Operation time

    Time frame: intraoperative

    defined as the time from skin incision or trocar placement to complete skin closure

  2. postoperative complications

    Time frame: up to 90 days

    Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system.Postoperative biliary leakage, hemorrhage, and liver failure were defined and classified according to the criteria set out by the International Study Group of Liver Surgery (ISGLS). Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.

  3. Reoperation within 90 days

    Time frame: up to 90 days

    defined as any reoperation within 90 days

  4. Mortality

    Time frame: up to 90 days

    defined as any death within 30 days and 90 days, respectively

  5. Readmission within 90 days

    Time frame: up to 90 days

    defined as any readmission within 90 days

  6. Operative details

    Time frame: intraoperative

    including blood transfusion, vascular resection, number of resected lymph nodes

  7. R0 resection

    Time frame: intraoperative

    defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins)

  8. Intraoperative blood loss

    Time frame: intraoperative

    recorded by the anesthetist using a vacuum system

  9. Vessel reconstruction

    Time frame: intraoperative

    defined as any repair or replacement of major vessels during surgery

Sponsors and collaborators

Lead sponsor

Renyi Qin

Other

Registry information

Official study title

Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC)：A Multicenter Real-world Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Jun 2, 2022
Registry last updated
Jun 2, 2022

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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