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Clinical Trials/NCT03936530
NCT03936530Active, not recruitingNot Applicable

Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon

Shanghai Minimally Invasive Surgery Center1 site in 1 country432 target enrollmentStarted: October 20, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
432
Locations
1
Primary Endpoint
metastasis rate

Study Overview

Brief Summary

The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) score I to III
  • A biopsy proven histological diagnosis of colorectal carcinoma
  • tumor located at hepatic flexure and right half of transverse colon
  • Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
  • Preoperative staging cT2-4aN0M0 or cTanyN+M0
  • Willing to participate and informed consent signed

Exclusion Criteria

  • Pregnant or lactating women
  • Synchronous colorectal carcinoma
  • History of colorectal cancer or other malignant tumors
  • Clinical evidence of metastasis
  • Preoperative staging cT1N0 or cT4bNany
  • Emergency procedure

Outcomes

Primary Outcomes

metastasis rate

Time Frame: an average of 1 year

metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node

Secondary Outcomes

  • intraoperative complication(an average of 1 year)
  • postoperative complication(an average of 1 year)
  • lymphadenectomy time(an average of 1 year)
  • 3-year DFS(an average of 3 years)

Investigators

Sponsor
Shanghai Minimally Invasive Surgery Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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