Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
laparoscopic right hemihepatectomy
Procedure/SurgeryLaparoscopic 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Hepatocellular carcinoma patients who received laparoscopic right hemihepatectomy1 intervention
Group B: Hepatocellular carcinoma patients who received open right hemihepatectomy0 interventions
Trial outcomes
Primary outcomes
1
Textbook outcome
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).
Time frame
From January 2018 to January 2023Secondary outcomes
1
Overall survival
Overall survival (OS) was defined as the interval from liver resection to death or the last follow-up.
Time frame
From January 2018 to January 20232
Disease-free survival
Disease-free survival (DFS) was defined as the time from liver resection to disease recurrence or death from any cause.
Time frame
From January 2018 to January 2023Sponsors and contacts
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Source ClinicalTrials.gov