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


N/A
18 Years
70 Years
Open (Enrolling by invite only)
Both
Liver Diseases, Liver Neoplasms, Hepatic Haemangioma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of participants with operation complication

Outcome 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.

Outcome Time Frame:

Duration hospitalization(an expected average of 8 days)

Safety Issue:

Yes

Principal Investigator

Shuguo Zheng

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

China: Ministry of Health

Study ID:

SWHZSG002

NCT ID:

NCT01567631

Start Date:

January 2012

Completion Date:

December 2017

Related Keywords:

  • Liver Diseases
  • Liver Neoplasms
  • Hepatic Haemangioma
  • Classical Procedure
  • Intrahepatic Glisson's Approach
  • laparoscopic hepatectomy
  • Minimal invasive surgery
  • Endoscopic stapling devices
  • Neoplasms
  • Hemangioma
  • Liver Diseases
  • Liver Neoplasms

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