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NCT Number: NCT06950827

Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma

Although traditional open right hemihepatectomy is a mature technique, the incision is usually very large; Intraoperative bleeding may be excessive, and postoperative liver failure is also prone to occur. In recent years, compared with traditional open surgery, laparoscopic surgery has many advantages, such as smaller surgical incision and faster postoperative recovery. In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible. However, due to the difficulty of the surgery, steep learning curve, and postoperative complications, its adoption is limited to high-capacity surgical centers. Despite significant progress in laparoscopic liver resection technology, its clinical efficacy remains controversial, especially in laparoscopic right hemihepatectomy. More research is needed to confirm the feasibility and safety of this surgery. At present, it is unclear whether there is a difference in textbook outcomes (TO) between HCC patients undergoing open and laparoscopic right hemihepatectomy, and the association between TO and patient survival prognosis.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatectomy Laparoscopic Hepatectomy Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Jiwei Huang Huang Professor

CONTACT

[email protected]

+86 18980606725

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old;
  • The lesion is limited to the right half of the liver and diagnosed as hepatocellular carcinoma based on paraffin pathology and immunohistochemistry results;
  • The type of surgery is elective surgery;
  • The patient's preoperative liver function was Child Pugh A or B grade, and the preoperative ASA (American Society of Anesthesiologists) rating was I, II, or III.

Exclusion criteria

  • Pathological confirmed cholangiocarcinoma, mixed cell carcinoma, or extrahepatic metastatic malignant tumors;
  • Previous history of upper abdominal surgery;
  • Simultaneously undergoing adjacent abdominal organ resection, major vessel and biliary reconstruction surgery, except for the gallbladder;
  • Merge adjacent organ invasions except for the gallbladder, with main blood vessels, bile duct cancer emboli, or distant metastases;
  • Lost to follow-up or loss of primary clinical data.

Treatment and study plan

laparoscopic right hemihepatectomy

Procedure

Laparoscopic surgery has many advantages, such as small surgical incision and fast postoperative recovery. In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible.

Primary outcomes

  1. Textbook outcome

    Time frame: From January 2018 to January 2023

    Textbook outcome (TO) was defined as the absence of intraoperative grade ≥ 2 incidents (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), postoperative liver failure grade B or C (according to the severity grading of the International Study Group of Liver Surgery), major postoperative complications within 90 days (Clavien-Dindo grade III or higher), readmission within 90 days after discharge due to surgery related major complications (Clavien-dindo Grade III or higher), in-hospital or 90-day mortality and the presence of R0 resection margin (i.e. 1mm or more tumor free margin).

Secondary outcomes

  1. Overall survival

    Time frame: From January 2018 to January 2023

    Overall survival (OS) was defined as the interval from liver resection to death or the last follow-up.

  2. Disease-free survival

    Time frame: From January 2018 to January 2023

    Disease-free survival (DFS) was defined as the time from liver resection to disease recurrence or death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang Professor

CONTACT

[email protected]

+86 18980606725

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma: a Comparative Study of Laparoscopic and Open Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

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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