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

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ClinicalTrials.gov Identifier: NCT02350166
Recruitment Status : Unknown
Verified November 2015 by Ziqiang Wang,MD, West China Hospital.
Recruitment status was:  Recruiting
First Posted : January 29, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: laparoscopic surgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Laparoscopic group
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
laparoscopic-assisted small-incision surgery

No Intervention: Conventional group
Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis



Primary Outcome Measures :
  1. 30-day complications [ Time Frame: Postoperative 30 days ]
    Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Postoperative 7 days ]
    Postoperative pain assessment

  2. Hospital time [ Time Frame: an expected average of 7 days ]
    Postoperative stay in hospital

  3. C-reactive protein [ Time Frame: Postoperative 5 days ]
    serum C-reactive protein level after operation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350166


Contacts
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Contact: Mingtian Wei, MD +8613198596090 m.weihx@gmail.com
Contact: Xiangbing Deng, MD +8613730677124 xiangbingdeng@gmail.com

Locations
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China, Sichuan
West China hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Ziqiang Wang, PhD,MD    +8618980602028    wzqtrial@gmail.com   
West China Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Ziqiang Wang, MD/PhD    +86-18980602028    wzqtrial@gmail.com   
Contact: Mingtian Wei, MD    +86-13198596090    m.weihx@gmail.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Ziqiang Wang, MD,PhD West China Hospital

Publications:

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Responsible Party: Ziqiang Wang,MD, Professor of the West China Hospital, Sichuan University, West China Hospital
ClinicalTrials.gov Identifier: NCT02350166    
Other Study ID Numbers: sLRC-201312
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Ziqiang Wang,MD, West China Hospital:
colorectal cancer
hepatectomy
laparoscopic surgery
laparotomy
complications
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases