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

NCT04422249 | Unknown DMC

• 1 other identifier: SWHZSG009
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Laparoscopic Middle hepatic vein Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Perioperative results

  Duration perioperation(an expected average of 3 days)

• intraoperative parameters

  during the operation

Other Outcomes (1)

• Incidence of postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

laparoscopic middle hepatic vein guidance hemihepatectomy

EXPERIMENTAL

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

laparoscopic traditional anatomic hemihepatectomy

ACTIVE COMPARATOR

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

Interventions

laparoscopic middle hepatic vein guidance anatomic hemihepatectomy PROCEDURE

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

Also known as: laparoscopic traditional anatomic hemihepatectomy

laparoscopic middle hepatic vein guidance hemihepatectomy; laparoscopic traditional anatomic hemihepatectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the site was limited to the patients who were suitable for dissecting hemihepatectomy；
• the type of disease was limited to hepatocellular carcinoma；
• the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
• child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
• 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；
• ≤ age ≤ 70, male or female.

You may not qualify if:

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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Shuguo Zheng, M.D.

CONTACT

0086-13508308676; shuguozh@yahoo.com.cn

Shuguo Zheng, Zheng

CONTACT

0086-13508308676; shuguozh@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two different treatments are conducted on the participant base on the randomized choices
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 9, 2020
• Study Start: December 23, 2019
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)