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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422249
• Other study ID #: SWHZSG009
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: December 23, 2023

Study information

• Verified date: December 2023
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng, M.D.
• Phone: 0086-13508308676
• Email: shuguozh[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 23, 2023
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	Perioperative results	the angle of hepatic vein between segment ? b and ?, angle between MHV and IVC	Duration perioperation(an expected average of 3 days)
Secondary	intraoperative parameters	blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c?)	during the operation