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Classical Procedure Versus Intrahepatic Glisson's Approach (LAHIGA)

Primary Purpose

Liver Diseases, Liver Neoplasms, Hepatic Haemangioma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

intrahepatic Glisson's approach

classical hepatectomy

About this trial

This is an interventional treatment trial for Liver Diseases focused on measuring Classical Procedure, Intrahepatic Glisson's Approach, laparoscopic hepatectomy, Minimal invasive surgery, Endoscopic stapling devices

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with liver malignant or benign disease distributed in a segment, lobe or half liver, malignant tumor ≤5 cm, without rupture, bleeding, and liver metastases, benign tumor ≤15cm.
Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved
Age: Between 18 to 70 years
Patients with regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region
Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria
Written informed consent

Exclusion Criteria:

Patients with bad general condition or important organ lesions, liver resection could not be tolerated
Age:Younger than 18 or more than 70 years old
Malignant tumor recurrence within one month postoperation
Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
Complicated case need to get emergency operation
Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated

Sites / Locations

Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intrahepatic Glisson's approach

classical hepatectomy

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with operation complication

Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation.

Secondary Outcome Measures

Number of participants with abnormal liver function or discomfort symptoms induced by the operation

Liver function, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The examination of ultrasound , CT and/or MR were perfomed in outpatient if necessary. The follow up interval time: every six months.

Full Information

NCT ID

NCT01567631

First Posted

March 26, 2012

Last Updated

January 29, 2016

Sponsor

Shuguo Zheng, MD

1. Study Identification

Unique Protocol Identification Number

NCT01567631

Brief Title

Classical Procedure Versus Intrahepatic Glisson's Approach

Acronym

LAHIGA

Official Title

Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shuguo Zheng, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. The investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach is safe, effective and feasible.

Detailed Description

Background: China is the high incidence area of liver disease, some of which need to be treated by surgical liver resection. The development of minimal invasive techniques opened up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical procedure are the two major operation procedures used in laparoscopic hepatectomy. The intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and shorter operation time in our experience and as previous studies. The investigators expect further comparison of the safety and efficacy through this prospective controlled study by using two kinds of operation procedures. Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective randomized study. Eighty patients with liver disease need undergo hepatectomy were selected and divided into intrahepatic Glisson's group and classical procedure group randomly, each group contains 40 cases. Total laparoscopic hepatectomy were performed, with the intrahepatic Glisson's approach or classical procedure respectively. Results: Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function,long-term curative effect were collected and analysed. Statistical method: groups t-test univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Diseases, Liver Neoplasms, Hepatic Haemangioma

Keywords

Classical Procedure, Intrahepatic Glisson's Approach, laparoscopic hepatectomy, Minimal invasive surgery, Endoscopic stapling devices

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intrahepatic Glisson's approach

Arm Type

Experimental

Arm Title

classical hepatectomy

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

intrahepatic Glisson's approach

Other Intervention Name(s)

Laparoscopic with Intrahepatic Glssion's approach

Intervention Description

Forty patients with liver disease were selected and divided into intrahepatic Glission's group as described in the detailed description.Total laparoscopic hepatectomy with intrahepatic Glisson's approach were performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle (containing arterial, portal, and bile duct branches ). A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler. The specimen was extracted through suprapubic incision.

Intervention Type

Procedure

Intervention Name(s)

classical hepatectomy

Other Intervention Name(s)

Laparoscopic anatomical hepatectomy with classical procedure

Intervention Description

Forty patients with liver disease were selected and divided into classical laparoscopic hepatectomy group as described in the detailed description.Total laparoscopic anatomical hepatectomy with classical procedure were performed.The initial step is to dissect hepatic portal and expose the liver artery, portal Vein branch and the bile duct. Then endoscopic stapler devices were used to cut the canal mentioned above. Final step is to divide the liver parenchyma along the following ischemic delineation.

Primary Outcome Measure Information:

Title

Number of participants with operation complication

Description

Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation.

Time Frame

Duration hospitalization(an expected average of 8 days)

Secondary Outcome Measure Information:

Title

Number of participants with abnormal liver function or discomfort symptoms induced by the operation

Description

Time Frame

up to 3 years postoperation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with liver malignant or benign disease distributed in a segment, lobe or half liver, malignant tumor ≤5 cm, without rupture, bleeding, and liver metastases, benign tumor ≤15cm. Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved Age: Between 18 to 70 years Patients with regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria Written informed consent Exclusion Criteria: Patients with bad general condition or important organ lesions, liver resection could not be tolerated Age:Younger than 18 or more than 70 years old Malignant tumor recurrence within one month postoperation Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis Complicated case need to get emergency operation Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuguo Zheng

Phone

0086-13508308676

shuguozh@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuguo Zheng

Organizational Affiliation

Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Southwest Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuguo Zheng, Professor

Phone

0086-13508308676

shuguozh@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

shuguo Zheng, professer

12. IPD Sharing Statement

Citations:

PubMed Identifier

17479334

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

20872017

Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

derived

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Classical Procedure Versus Intrahepatic Glisson's Approach

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