NCT02350166

Brief Summary

Surgical resection is still recommended as the optional treatment for colorectal liver metastasis (CLM) patients. There are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery, has gained wide population from gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to surgical type, Open liver resection is the optimum choice for CLM patients no matter what the metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. So, primary colorectal tumor resection could be either open or laparoscopic procedure. Therefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries.

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
40

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

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

November 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

January 19, 2015

Last Update Submit

November 15, 2015

Conditions

Colorectal Cancer

Keywords

colorectal cancerhepatectomylaparoscopic surgerylaparotomycomplications

Outcome Measures

Primary Outcomes (1)

  • 30-day complications

    Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage

    Postoperative 30 days

Secondary Outcomes (3)

  • Pain score

    Postoperative 7 days

  • Hospital time

    an expected average of 7 days

  • C-reactive protein

    Postoperative 5 days

Study Arms (2)

Laparoscopic group

EXPERIMENTAL

Laparoscopic group, laparoscopic surgery or laparoscopic-assisted small-incision for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis

Procedure: laparoscopic surgery

Conventional group

NO INTERVENTION

Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis

Interventions

laparoscopic surgeryPROCEDURE

laparoscopic-assisted small-incision surgery

Laparoscopic group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed resectable upper rectal cancer, sigmoid cancer, and left colon cancer
  • MRI/CT confirmed resectable liver metastasis after muti-disciplinary team assessment
  • No evidence of other metastasis
  • Organs function well to tolerance simultaneous surgery, especially liver function
  • No special treatment before surgery
  • Informed consent was written

You may not qualify if:

  • Right colon cancer and transverse colon cancer
  • Pregnant or lactating women
  • A history of malignant tumor within 5 years
  • There was contraindication for operation
  • Discovery of metastasis in other organs in the operation
  • With mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West China hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (8)

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PMID: 21296855BACKGROUND

  • Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17.

    PMID: 21685461BACKGROUND

  • Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10.

    PMID: 16904315BACKGROUND

  • Kemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. doi: 10.1056/NEJM199912303412702.

    PMID: 10615075BACKGROUND

  • Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, Kemeny N, Brennan MF, Blumgart LH, D'Angelica M. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007 Oct 10;25(29):4575-80. doi: 10.1200/JCO.2007.11.0833.

    PMID: 17925551BACKGROUND

  • Li ZQ, Liu K, Duan JC, Li Z, Su CQ, Yang JH. Meta-analysis of simultaneous versus staged resection for synchronous colorectal liver metastases. Hepatol Res. 2013 Jan;43(1):72-83. doi: 10.1111/j.1872-034X.2012.01050.x. Epub 2012 Sep 13.

    PMID: 22971038BACKGROUND

  • Wei M, He Y, Wang J, Chen N, Zhou Z, Wang Z. Laparoscopic versus open hepatectomy with or without synchronous colectomy for colorectal liver metastasis: a meta-analysis. PLoS One. 2014 Jan 29;9(1):e87461. doi: 10.1371/journal.pone.0087461. eCollection 2014.

    PMID: 24489916BACKGROUND

  • Arezzo A, Passera R, Scozzari G, Verra M, Morino M. Laparoscopy for rectal cancer reduces short-term mortality and morbidity: results of a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1485-502. doi: 10.1007/s00464-012-2649-x. Epub 2012 Nov 25.

    PMID: 23183871BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ziqiang Wang, MD,PhD

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingtian Wei, MD

CONTACT

+8613198596090m.weihx@gmail.com

Xiangbing Deng, MD

CONTACT

+8613730677124xiangbingdeng@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of the West China Hospital, Sichuan University

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 29, 2015

Study Start

November 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

CN(2)