Clinical trial NCT04422249: A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Official title: A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Laparoscopic Middle hepatic vein Hepatocellular carcinoma
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.

Detailed description: Backgroud \& Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.

Eligibility criteria: Inclusion Criteria:

1. the site was limited to the patients who were suitable for dissecting hemihepatectomy；
2. the type of disease was limited to hepatocellular carcinoma；
3. the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
4. child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
5. the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
6. 18 ≤ age ≤ 70, male or female.

Exclusion Criteria:

1. preoperative liver function Child-pugh grade B or C;
2. patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
3. patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
4. patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
5. repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited

Primary outcomes:
measure: Survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Perioperative results
timeFrame: Duration perioperation(an expected average of 3 days)
measure: intraoperative parameters
timeFrame: during the operation
Other outcomes:
measure: Incidence of postoperative complications
timeFrame: Duration hospitalization(an expected average of 7 days)
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: