Classical Procedure Versus Intrahepatic Glisson's Approach (LAHIGA)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shuguo Zheng, MD, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01567631
First received: March 26, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Liver Diseases
Liver Neoplasms
Hepatic Haemangioma
Procedure: intrahepatic Glisson's approach
Procedure: classical hepatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Number of participants with operation complication [ Time Frame: Duration hospitalization(an expected average of 8 days) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 3 years postoperation ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intrahepatic Glisson's approach Procedure: intrahepatic Glisson's approach
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.
Other Name: Laparoscopic with Intrahepatic Glssion's approach
Active Comparator: classical hepatectomy Procedure: classical hepatectomy
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.
Other Name: Laparoscopic anatomical hepatectomy with classical procedure

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:

  1. 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.
  2. Statistical method: groups t-test univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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
  3. Age: Between 18 to 70 years
  4. 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
  5. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
  6. Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria
  7. Written informed consent

Exclusion Criteria:

  1. Patients with bad general condition or important organ lesions, liver resection could not be tolerated
  2. Age:Younger than 18 or more than 70 years old
  3. Malignant tumor recurrence within one month postoperation
  4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
  5. Complicated case need to get emergency operation
  6. 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01567631

Sponsors and Collaborators
Shuguo Zheng, MD
Investigators
Study Director: Shuguo Zheng Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
  More Information

Publications:

Responsible Party: Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01567631     History of Changes
Other Study ID Numbers: SWHZSG002, Zhengshuguo
Study First Received: March 26, 2012
Last Updated: March 29, 2012
Health Authority: China: Ministry of Health

Keywords provided by Southwest Hospital, China:
Classical Procedure
Intrahepatic Glisson's Approach
laparoscopic hepatectomy
Minimal invasive surgery
Endoscopic stapling devices

Additional relevant MeSH terms:
Liver Diseases
Hemangioma
Liver Neoplasms
Digestive System Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 30, 2014