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
Study Sites (1)
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