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AzTrials

Hepatocellular CarcinomaNCT02526043

Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

A study testing laparoscopic hepatectomy and Open hepatectomy in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
laparoscopic hepatectomy and Open hepatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
Aug 2015to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis was HCC
  • The tumor was located in segment: II, III, IVb, V, VI
  • The tumor diameter < 5cm
  • Without thrombosis in the portal vein, hepatic vein or bile duct
  • Without intrahepatic and systemic metastasis
  • The Child-pugh score was A-B7
Show all 9Show fewer
  • The ASA（American Society of Anesthesiologists） score was I-III
  • The patient age was between 18-75
  • Sign the informed consent, and can fully understand the research content

Who cannot join

  • Have surgery contraindications
  • Pregnant or lactating women
  • The Child-pugh score was B8-C
  • The ASA（American Society of Anesthesiologists） score was IV-V
  • With other malignant tumor
  • With mental illness
  • Participated in other clinical trials in the last three months
  • Underwent other treatments(chemotherapy or radiotherapy) before operation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan hospital

    Shanghai, 200040

Other trials in China

About this study

Official title: A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Read the detailed description

Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI.

Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.

So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.

This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Being tested
laparoscopic hepatectomy, Open hepatectomy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic hepatectomyProcedure or surgery

    The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy

  • Open hepatectomyProcedure or surgery

    The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery

Study groups in NCT02526043
Study groupRoleWhat they receive
laparoscopic hepatectomyExperimentalThe HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery
Receives: Procedure: laparoscopic hepatectomy
Open hepatectomyExperimentalThe HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery
Receives: Procedure: Open hepatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    The overall survival of HCC patients after operation

    Measured: 5 years

Secondary outcomes (2)

  1. Disease free survival

    The disease free survival of HCC patients after operation

    Measured: 5 years

  2. Incidence of postoperative complications

    Incidence of postoperative complications

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02526043
Sponsor's protocol ID
Huashan 002
Status last verified
Aug 2022
First submitted
5 Aug 2015
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ishizawa T, Gumbs AA, Kokudo N, Gayet B. Laparoscopic segmentectomy of the liver: from segment I to VIII. Ann Surg. 2012 Dec;256(6):959-64. doi: 10.1097/SLA.0b013e31825ffed3.

    PubMed 22968066

  • Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.

    PubMed 1833688

  • Chen KH, Jeng KS, Huang SH, Chu SH. Laparoscopic caudate hepatectomy for cancer--an innovative approach to the no-man's land. J Gastrointest Surg. 2013 Mar;17(3):522-6. doi: 10.1007/s11605-012-2115-z. Epub 2013 Jan 8.

    PubMed 23297026

  • Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30. doi: 10.1097/sla.0b013e3181b3b2d8.

    PubMed 19916210

  • Afaneh C, Kluger MD. Laparoscopic liver resection: lessons at the end of the second decade. Semin Liver Dis. 2013 Aug;33(3):226-35. doi: 10.1055/s-0033-1351780. Epub 2013 Aug 13. Danish, English.

    PubMed 23943103

  • Bryant R, Laurent A, Tayar C, Cherqui D. Laparoscopic liver resection-understanding its role in current practice: the Henri Mondor Hospital experience. Ann Surg. 2009 Jul;250(1):103-11. doi: 10.1097/SLA.0b013e3181ad6660.

    PubMed 19561476

  • Topal B, Fieuws S, Aerts R, Vandeweyer H, Penninckx F. Laparoscopic versus open liver resection of hepatic neoplasms: comparative analysis of short-term results. Surg Endosc. 2008 Oct;22(10):2208-13. doi: 10.1007/s00464-008-0023-9. Epub 2008 Jul 12.

    PubMed 18622562

  • Tranchart H, Di Giuro G, Lainas P, Roudie J, Agostini H, Franco D, Dagher I. Laparoscopic resection for hepatocellular carcinoma: a matched-pair comparative study. Surg Endosc. 2010 May;24(5):1170-6. doi: 10.1007/s00464-009-0745-3. Epub 2009 Nov 14.

    PubMed 19915908

  • Cai XJ, Yang J, Yu H, Liang X, Wang YF, Zhu ZY, Peng SY. Clinical study of laparoscopic versus open hepatectomy for malignant liver tumors. Surg Endosc. 2008 Nov;22(11):2350-6. doi: 10.1007/s00464-008-9789-z. Epub 2008 Feb 23.

    PubMed 18297354

  • Dagher I, Lainas P, Carloni A, Caillard C, Champault A, Smadja C, Franco D. Laparoscopic liver resection for hepatocellular carcinoma. Surg Endosc. 2008 Feb;22(2):372-8. doi: 10.1007/s00464-007-9487-2. Epub 2007 Aug 18.

    PubMed 17704878

  • Lee KF, Chong CN, Wong J, Cheung YS, Wong J, Lai P. Long-term results of laparoscopic hepatectomy versus open hepatectomy for hepatocellular carcinoma: a case-matched analysis. World J Surg. 2011 Oct;35(10):2268-74. doi: 10.1007/s00268-011-1212-6.

    PubMed 21842300

  • Slim A, Garancini M, Di Sandro S, Mangoni I, Lauterio A, Giacomoni A, De Carlis L. Laparoscopic versus open liver surgery: a single center analysis of post-operative in-hospital and post-discharge results. Langenbecks Arch Surg. 2012 Dec;397(8):1305-11. doi: 10.1007/s00423-012-0992-y. Epub 2012 Aug 24.

    PubMed 22918605

  • Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26.

    PubMed 23099728

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic hepatectomy and Open hepatectomy in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526043, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.

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