Clinical trial NCT01567631: Classical Procedure Versus Intrahepatic Glisson's Approach
Official title: Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Liver Neoplasms
Hepatic Haemangioma
Keywords: Classical Procedure
Intrahepatic Glisson's Approach
laparoscopic hepatectomy
Minimal invasive surgery
Endoscopic stapling devices
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
measure: Number of participants with operation complication
timeFrame: Duration hospitalization(an expected average of 8 days)
Secondary outcomes:
measure: Number of participants with abnormal liver function or discomfort symptoms induced by the operation
timeFrame: up to 3 years postoperation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Shuguo Zheng
role: STUDY_DIRECTOR
References:
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. doi: 10.1007/s00464-007-9303-z. Epub 2007 May 4.
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. doi: 10.1007/s00464-007-9253-5. Epub 2007 Mar 14.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
citation: Liao KX, Yu F, Cao L, Wang BL, Li XS, Wang XJ, Li JW, Fan YD, Chen J, Zheng SG. Laparoscopic Glissonian pedicle versus hilar dissection approach hemihepatectomy: A prospective, randomized controlled trial. J Hepatobiliary Pancreat Sci. 2022 Jun;29(6):629-640. doi: 10.1002/jhbp.1129. Epub 2022 Mar 10.