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Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
laparoscopic surgery
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, hepatectomy, laparoscopic surgery, laparotomy, complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • West China hospital, Sichuan UniversityRecruiting
  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laparoscopic group

Conventional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain score
Postoperative pain assessment
Hospital time
Postoperative stay in hospital
C-reactive protein
serum C-reactive protein level after operation

Full Information

First Posted
January 19, 2015
Last Updated
November 15, 2015
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02350166
Brief Title
Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis
Official Title
Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Nowadays, colorectal liver metastasis (CLM) is gaining wide population from multi-disciplinary doctors including gastroenterologists, oncologists, and hepatic doctors for its increasing incidence and poor prognosis. Nearly, 15%-25% of colorectal cancer patients present with simultaneous liver metastasis at the time of diagnosis and 20%-35% patients are evaluated with primary tumor and liver metastasis resectable synchronously. Although the use of chemotherapy regimen has been certified favorable outcomes, surgical resection is still recommended as the optional treatment for CLM patients. However, there are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, a latest evidence shows synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery. Moreover, an increasing number of surgeons favor synchronous resection from their initial experience and they believe it will bring benefits to CLM patients. With regard to surgical type, although laparoscopic liver resection has been proven feasible, safe and efficient in management of liver metastasis, this procedure is limited in selected patients such as tumor size less than 10 centimeters or located in left liver. In addition, laparoscopic liver resection is technically difficult which is applied in most medical centers. So open liver resection may be the optimum choice for CLM patients no matter what the metastasis profile is. In the management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. A research conducted by Arezzo also confirms lower 30-day morbidity of laparoscopic colorectal cancer resection. Unlike liver metastasis resection, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, hepatectomy, laparoscopic surgery, laparotomy, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic group
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Description
laparoscopic-assisted small-incision surgery
Primary Outcome Measure Information:
Title
30-day complications
Description
Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage
Time Frame
Postoperative 30 days
Secondary Outcome Measure Information:
Title
Pain score
Description
Postoperative pain assessment
Time Frame
Postoperative 7 days
Title
Hospital time
Description
Postoperative stay in hospital
Time Frame
an expected average of 7 days
Title
C-reactive protein
Description
serum C-reactive protein level after operation
Time Frame
Postoperative 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingtian Wei, MD
Phone
+8613198596090
Email
m.weihx@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbing Deng, MD
Phone
+8613730677124
Email
xiangbingdeng@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD,PhD
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, PhD,MD
Phone
+8618980602028
Email
wzqtrial@gmail.com
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD/PhD
Phone
+86-18980602028
Email
wzqtrial@gmail.com
First Name & Middle Initial & Last Name & Degree
Mingtian Wei, MD
Phone
+86-13198596090
Email
m.weihx@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21296855
Citation
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. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
Results Reference
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PubMed Identifier
21685461
Citation
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.
Results Reference
background
PubMed Identifier
16904315
Citation
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.
Results Reference
background
PubMed Identifier
10615075
Citation
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.
Results Reference
background
PubMed Identifier
17925551
Citation
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.
Results Reference
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PubMed Identifier
22971038
Citation
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.
Results Reference
background
PubMed Identifier
24489916
Citation
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.
Results Reference
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PubMed Identifier
23183871
Citation
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.
Results Reference
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Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis

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