NCT01567631

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

5.9 years

First QC Date

March 26, 2012

Last Update Submit

January 29, 2016

Conditions

Liver DiseasesLiver NeoplasmsHepatic Haemangioma

Keywords

Classical ProcedureIntrahepatic Glisson's Approachlaparoscopic hepatectomyMinimal invasive surgeryEndoscopic stapling devices

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Number of participants with abnormal liver function or discomfort symptoms induced by the operation

    up to 3 years postoperation

Study Arms (2)

intrahepatic Glisson's approach

EXPERIMENTAL
Procedure: intrahepatic Glisson's approach

classical hepatectomy

ACTIVE COMPARATOR
Procedure: classical hepatectomy

Interventions

intrahepatic Glisson's approachPROCEDURE

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.

Also known as: Laparoscopic with Intrahepatic Glssion's approach
intrahepatic Glisson's approach
classical hepatectomyPROCEDURE

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.

Also known as: Laparoscopic anatomical hepatectomy with classical procedure
classical hepatectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • Age: Between 18 to 70 years
  • 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
  • Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved

You may not qualify if:

  • Written informed consent
  • Patients with bad general condition or important organ lesions, liver resection could not be tolerated
  • Age:Younger than 18 or more than 70 years old
  • Malignant tumor recurrence within one month postoperation
  • Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
  • Complicated case need to get emergency operation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (12)

  • 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.

    PMID: 17479334BACKGROUND

  • 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.

    PMID: 17356935BACKGROUND

  • 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.

    PMID: 20872017BACKGROUND

  • 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.

    PMID: 18926454BACKGROUND

  • 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.

    PMID: 19221325BACKGROUND

  • 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.

    PMID: 19375067BACKGROUND

  • 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.

    PMID: 18333077BACKGROUND

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

    PMID: 18773098BACKGROUND

  • 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.

    PMID: 18773113BACKGROUND

  • 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.

    PMID: 18333081BACKGROUND

  • 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.

    PMID: 19801936BACKGROUND

  • 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.

    PMID: 35224875DERIVED

MeSH Terms

Conditions

Liver DiseasesLiver Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shuguo Zheng

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

    STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng

CONTACT

0086-13508308676shuguozh@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 30, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

CN(1)