Classical Procedure Versus Intrahepatic Glisson's Approach

Liver Diseases Clinical Trial

— LAHIGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01567631
• Other study ID #: SWHZSG002
• Secondary ID: Zhengshuguo
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: January 29, 2016
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng
• Phone: 0086-13508308676
• Email: shuguozh[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemangioma
• Hepatic Haemangioma
• Liver Diseases
• Liver Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Shuguo Zheng, MD

Country where clinical trial is conducted

China, 

References & Publications (11)

Astudillo JA, Sporn E, Serrano B, Astudillo R. Ascariasis in the hepatobiliary system: laparoscopic management. J Am Coll Surg. 2008 Oct;207(4):527-32. doi: 10.1016/j.jamcollsurg.2008.05.020. Epub 2008 Jul 14. — View Citation

Belli G, Fantini C, D'Agostino A, Belli A, Russolillo N. Laparoscopic liver resections for hepatocellular carcinoma (HCC) in cirrhotic patients. HPB (Oxford). 2004;6(4):236-46. doi: 10.1080/13651820410023941. — View Citation

Cho A, Asano T, Yamamoto H, Nagata M, Takiguchi N, Kainuma O, Souda H, Gunji H, Miyazaki A, Nojima H, Ikeda A, Matsumoto I, Ryu M, Makino H, Okazumi S. Laparoscopy-assisted hepatic lobectomy using hilar Glissonean pedicle transection. Surg Endosc. 2007 Aug;21(8):1466-8. Epub 2007 Mar 14. — View Citation

Cho A, Yamamoto H, Kainuma O, Souda H, Ikeda A, Takiguchi N, Nagata M. Safe and feasible extrahepatic Glissonean access in laparoscopic anatomical liver resection. Surg Endosc. 2011 Apr;25(4):1333-6. doi: 10.1007/s00464-010-1358-6. Epub 2010 Sep 25. — View Citation

Dagher I, Diop PS, Lainas P, Carloni A, Franco D. Laparoscopic liver resection for localized primary intrahepatic bile duct dilatation. Am J Surg. 2010 Jan;199(1):131-5. doi: 10.1016/j.amjsurg.2008.12.027. Epub 2009 Apr 17. — View Citation

Gigot JF, Hubert C, Banice R, Kendrick ML. Laparoscopic management of benign liver diseases: where are we? HPB (Oxford). 2004;6(4):197-212. doi: 10.1080/13651820410023950. — View Citation

Gumbs AA, Gayet B, Gagner M. Laparoscopic liver resection: when to use the laparoscopic stapler device. HPB (Oxford). 2008;10(4):296-303. doi: 10.1080/13651820802166773. — View Citation

Koffron AJ, Stein JA. Laparoscopic liver surgery: parenchymal transection using saline-enhanced electrosurgery. HPB (Oxford). 2008;10(4):225-8. doi: 10.1080/13651820802166864. — View Citation

Lai EC, Tang CN, Ha JP, Li MK. Laparoscopic liver resection for hepatocellular carcinoma: ten-year experience in a single center. Arch Surg. 2009 Feb;144(2):143-7; discussion 148. doi: 10.1001/archsurg.2008.536. — View Citation

Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df. Review. — View Citation

Topal B, Aerts R, Penninckx F. Laparoscopic intrahepatic Glissonian approach for right hepatectomy is safe, simple, and reproducible. Surg Endosc. 2007 Nov;21(11):2111. Epub 2007 May 4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration hospitalization(an expected average of 8 days)	Yes
Secondary	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.	up to 3 years postoperation	Yes