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NCT03936530 Clinical Trial

Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Colorectal Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03936530
Other study ID # MISC- Infrapyloric LNM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 20, 2019
Est. completion date August 1, 2026

Study information
Verified date March 2024
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 432
Est. completion date August 1, 2026
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Ruijin hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary metastasis rate metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node an average of 1 year
Secondary lymphadenectomy time time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node an average of 1 year
Secondary intraoperative complication intraoperative complication an average of 1 year
Secondary postoperative complication postoperative complication an average of 1 year
Secondary 3-year DFS 3-year disease free survival an average of 3 years
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