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

NCT ID: NCT04422249

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2023-12-23

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Keywords

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Laparoscopic Middle hepatic vein Hepatocellular carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Two different treatments are conducted on the participant base on the randomized choices

Study Groups

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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.

Group Type EXPERIMENTAL

laparoscopic middle hepatic vein guidance anatomic hemihepatectomy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

laparoscopic middle hepatic vein guidance anatomic hemihepatectomy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic traditional anatomic hemihepatectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Shuguo Zheng, MD

Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuguo Zheng, M.D.

Role: CONTACT

Phone: 0086-13508308676

Email: [email protected]

Shuguo Zheng, Zheng

Role: CONTACT

Phone: 0086-13508308676

Email: [email protected]

Facility Contacts

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Shuguo Zheng, MD

Role: primary

Other Identifiers

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SWHZSG009

Identifier Type: -

Identifier Source: org_study_id