Classical Procedure Versus Intrahepatic Glisson's Approach (LAHIGA)
|ClinicalTrials.gov Identifier: NCT01567631|
Recruitment Status : Unknown
Verified January 2016 by Shuguo Zheng, MD, Southwest Hospital, China.
Recruitment status was: Recruiting
First Posted : March 30, 2012
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment|
|Liver Diseases Liver Neoplasms Hepatic Haemangioma||Procedure: intrahepatic Glisson's approach Procedure: classical hepatectomy|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|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
- Number of participants with operation complication [ Time Frame: Duration hospitalization(an expected average of 8 days) ]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.
- Number of participants with abnormal liver function or discomfort symptoms induced by the operation [ Time Frame: up to 3 years postoperation ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567631
|Contact: Shuguo Zhengemail@example.com|
|Chongqing, Chongqing, China, 400038|
|Contact: Shuguo Zheng, Professor 0086-13508308676 firstname.lastname@example.org|
|Principal Investigator: shuguo Zheng, professer|
|Study Director:||Shuguo Zheng||Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University|