A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy

A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuguo Zheng, M.D.; Phone Number: 0086-13508308676; Email: shuguozh@yahoo.com.cn
• Study Contact Backup: Name: Shuguo Zheng, Zheng; Phone Number: 0086-13508308676; Email: shuguozh@yahoo.com.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital
      • Contact: Shuguo Zheng, MD; Phone Number: 0086-13508308676; Email: shuguozh@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic middle hepatic vein guidance hemihepatectomy; In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation.	Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy; 95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period; Other Names: laparoscopic traditional anatomic hemihepatectomy
Active Comparator: laparoscopic traditional anatomic hemihepatectomy; According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained.	Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy; 95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period; Other Names: laparoscopic traditional anatomic hemihepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative results	the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC	Duration perioperation(an expected average of 3 days)
intraoperative parameters	blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）	during the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications	hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency，liver function failure	Duration hospitalization(an expected average of 7 days)

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Estimated): December 23, 2023
• Study Completion (Estimated): December 23, 2023

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: June 6, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic Middle hepatic vein Hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: SWHZSG009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No