NCT02009176

Brief Summary

The purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology.

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
110

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable hepatocellular-carcinoma

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

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

9 years

First QC Date

December 8, 2013

Last Update Submit

February 10, 2022

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaLaparoscopicAon-anatomical hepatectomyAnatomical hepatectomyMicrometastases

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 3-year and 5-year survival, disease-free survival, recurrence rate.

    5 years

Secondary Outcomes (1)

  • postoperative complications

    Duration hospitalization(an expected average of 7 days)

Study Arms (2)

Laparoscop Anatomical Hepatectomy

EXPERIMENTAL

Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively.

Procedure: Laparoscopic Anatomical Hepatectomy

Laparoscope Aon-anatomical Hepatectomy

ACTIVE COMPARATOR

Total laparoscopic aon-anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound or hepatic segmental staining will be used to ensure the tumour was completely resected.

Procedure: Laparoscopic Aon-anatomical Hepatectomy

Interventions

Laparoscopic Anatomical HepatectomyPROCEDURE

We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath

Laparoscop Anatomical Hepatectomy
Laparoscopic Aon-anatomical HepatectomyPROCEDURE

We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy

Laparoscope Aon-anatomical Hepatectomy

Eligibility Criteria

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

You may qualify if:

  • (1) both male and female, aged 18 to 70; (2) Hepatocellular carcinoma(HCC)diagnosis is clear preoperative; (3) preoperative liver function evaluation: Child-Pugh =\> B; (4) the lesions can be anatomical hepatectomy,( Indocyanine Green retention rate of 15 minutes) ICGR-15\< 20%, the remaining liver volume is sufficient; (5) hepatic single lesions and tumor size between 3-10 cm, does not Invasion the main vein, hepatic artery and vein and major inferior vena cava, did not occur extrahepatic metastasis, and laparoscopic can complete resection; (6) surgery, radiofrequency ablation (RFA), TACE treatment, radiotherapy and chemotherapy have not been implemented (7) voluntary participation in the study, and informed consent.

You may not qualify if:

  • (1) age \<18 years or\> 70 years , pregnant or lactating women; (2) HCC diagnosis is not clear; (3) preoperative liver function evaluation: Child-Pugh C grade; (4) ICGR-15\> 20%, the remaining liver volume is insufficient (account for standard liver volume \<35%); (5) preoperative tumor has ruptured, or has been undergoing surgery, radiofrequency ablation (RFA), transhepatic arterial chemotherapy and embolization(TACE) or radiotherapy and chemotherapy treatment; (6) preoperative examinations showed multiple (\>3)liver lesion or tumor diameter \<3 or\> 10 cm, a clearly major portal vein, hepatic vein, inferior vena vein tumor thrombus; (7) extrahepatic metastasis; (8) cardio-pulmonary function and other diseases can not tolerate surgery; (9) the patient refused to sign the informed consent form; (10) the tumor has spread and / or lymph node metastasis intraoperative found ; (11) intraoperative found not to be the HCC, such as metastatic hepatic carcinoma, hilar cell carcinoma; (12) Histological examinations showed it is cholangio carcinoma, or mixed liver carcinoma; (13) foreign and Hong Kong, Macao, Taiwan or other areas, estimated that difficult to track, follow-up postoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (12)

  • Bosch FX, Ribes J, Diaz M, Cleries R. Primary liver cancer: worldwide incidence and trends. Gastroenterology. 2004 Nov;127(5 Suppl 1):S5-S16. doi: 10.1053/j.gastro.2004.09.011.

    PMID: 15508102BACKGROUND

  • Kaido T. Recent randomized controlled trials in hepatectomy. Hepatogastroenterology. 2007 Sep;54(78):1825-30.

    PMID: 18019727BACKGROUND

  • Man K, Fan ST, Ng IO, Lo CM, Liu CL, Wong J. Prospective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study. Ann Surg. 1997 Dec;226(6):704-11; discussion 711-3. doi: 10.1097/00000658-199712000-00007.

    PMID: 9409569BACKGROUND

  • Figueras J, Llado L, Ruiz D, Ramos E, Busquets J, Rafecas A, Torras J, Fabregat J. Complete versus selective portal triad clamping for minor liver resections: a prospective randomized trial. Ann Surg. 2005 Apr;241(4):582-90. doi: 10.1097/01.sla.0000157168.26021.b8.

    PMID: 15798459BACKGROUND

  • Kobayashi A, Miyagawa S, Miwa S, Nakata T. Prognostic impact of anatomical resection on early and late intrahepatic recurrence in patients with hepatocellular carcinoma. J Hepatobiliary Pancreat Surg. 2008;15(5):515-21. doi: 10.1007/s00534-007-1293-7. Epub 2008 Oct 4.

    PMID: 18836806BACKGROUND

  • Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. doi: 10.1097/01.sla.0000171307.37401.db.

    PMID: 16041216BACKGROUND

  • Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.

    PMID: 11420484BACKGROUND

  • Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41.

    PMID: 14607620BACKGROUND

  • Hanazaki K, Kajikawa S, Shimozawa N, Matsushita A, Machida T, Shimada K, Yazawa K, Koide N, Adachi W, Amano J. Perioperative blood transfusion and survival following curative hepatic resection for hepatocellular carcinoma. Hepatogastroenterology. 2005 Mar-Apr;52(62):524-9.

    PMID: 15816471BACKGROUND

  • Man K, Ng KT, Lo CM, Ho JW, Sun BS, Sun CK, Lee TK, Poon RT, Fan ST. Ischemia-reperfusion of small liver remnant promotes liver tumor growth and metastases--activation of cell invasion and migration pathways. Liver Transpl. 2007 Dec;13(12):1669-77. doi: 10.1002/lt.21193.

    PMID: 18044786BACKGROUND

  • Man K, Lo CM, Xiao JW, Ng KT, Sun BS, Ng IO, Cheng Q, Sun CK, Fan ST. The significance of acute phase small-for-size graft injury on tumor growth and invasiveness after liver transplantation. Ann Surg. 2008 Jun;247(6):1049-57. doi: 10.1097/SLA.0b013e31816ffab6XXX.

    PMID: 18520234BACKGROUND

  • Liao K, Yang K, Cao L, Lu Y, Zheng B, Li X, Wang X, Li J, Chen J, Zheng S. Laparoscopic Anatomical Versus Non-anatomical hepatectomy in the Treatment of Hepatocellular Carcinoma: A randomised controlled trial. Int J Surg. 2022 Jun;102:106652. doi: 10.1016/j.ijsu.2022.106652. Epub 2022 May 4.

    PMID: 35525414DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplasm Micrometastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

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@gmail.com

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

December 8, 2013

First Posted

December 11, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

CN(1)