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A Novel Technique of HALS With CME and CVL for RCC

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ClinicalTrials.gov Identifier: NCT02625272
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

Brief Summary:
The purpose of this study is to determine the short and long outcomes of the novel technique of hand-assisted laparoscopic right hemicolectomy with complete mesocolic excision and central vascular ligation for right colon cancer.

Condition or disease Intervention/treatment Phase
Colon Neoplasms Procedure: Group A Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Technique of Hand-assisted Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer: A Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
Procedure: Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.

No Intervention: Group B
novel laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were divided at the beginning of the operation intracorporeally.
No Intervention: Group C
the traditional laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer.



Primary Outcome Measures :
  1. operative time [ Time Frame: 1 day ]
  2. the content RNA of CEA and CK20 in circulating tumor cells and ascites [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. postoperative complications [ Time Frame: 1 year ]
  2. overall survival [ Time Frame: 3 years ]
  3. disease-free survival [ Time Frame: 3 years ]
  4. 3-year local recurrence [ Time Frame: 3 years ]


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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:

  • Histologically confirmed right colon cancer
  • Clinical stage: I, II, III
  • No preoperative chemoradiotherapy
  • No past surgical history
  • No serious preoperative complication
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
  • Age: 18-80
  • Written informed consent

Exclusion Criteria:

  • Malignant neoplasm of other sites (including transverse, descending, sigmoid colon cancer, and rectal cancer)
  • Metastatic cancer
  • Multiple cancer
  • Serious complications (including bowel perforation, bowel obstruction, gastrointestinal hemorrhage)
  • Pregnant and lactating women
  • Psychological disorder
  • Steroid administration
  • Cardiac infarction within six months
  • Severe pulmonary emphysema and pulmonary fibrosis

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): NCT02625272


Contacts
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Contact: Ziqiang Wang, MD,PhD +8618980602028 wangzqzyh@163.com
Contact: Xuyang Yang, MD +8618280456901 yangxuyang15@163.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   
Contact: Xuyang Yang, MD    +8618280456901    yangxuyang15@163.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Ziqiang Wang, MD,PhD West China Hospital

Publications:
Petrovic T, Radovanovic Z, Breberina M, et al. Complete mesocolic excision with central supplying vessel ligation- new technique in colon cancer treatment. Arch Oncol, 2010; 18(3) : 84- 85.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ziqiang Wang,MD, Chief of Department of Gastrointestinal Surgery, West China Hospital
ClinicalTrials.gov Identifier: NCT02625272     History of Changes
Other Study ID Numbers: HALS-CME 201512
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Keywords provided by Ziqiang Wang,MD, West China Hospital:
hand-assisted laparoscopic surgery
right colon cancer
complete mesocolic excision
no touch isolation
recurrence
overall survival
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases