Clinical trial NCT06950827: Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma
Official title: Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma: a Comparative Study of Laparoscopic and Open Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Hepatectomy
Laparoscopic Hepatectomy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data was collected from patients who underwent right hemihepatectomy and were diagnosed with HCC pathologically. The data was collected from the division of Liver Surgery of West China Hospital, SCU from January 2018 to January 2023.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. The lesion is limited to the right half of the liver and diagnosed as hepatocellular carcinoma based on paraffin pathology and immunohistochemistry results;
3. The type of surgery is elective surgery;
4. 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:

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

Primary outcomes:
measure: Textbook outcome
timeFrame: From January 2018 to January 2023
Secondary outcomes:
measure: Overall survival
timeFrame: From January 2018 to January 2023
measure: Disease-free survival
timeFrame: From January 2018 to January 2023
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: