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出境医 / 临床实验 / Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Study Description
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.

Condition or disease
Colorectal Neoplasm

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 427 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Actual Study Start Date : October 20, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2025
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. metastasis rate [ Time Frame: an average of 1 year ]
    metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node


Secondary Outcome Measures :
  1. lymphadenectomy time [ Time Frame: an average of 1 year ]
    time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node

  2. intraoperative complication [ Time Frame: an average of 1 year ]
    intraoperative complication

  3. postoperative complication [ Time Frame: an average of 1 year ]
    postoperative complication

  4. 3-year DFS [ Time Frame: an average of 3 years ]
    3-year disease free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in Shanghai Minimally Invasive Surgery Center
Criteria

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
Contacts and Locations

Contacts
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Contact: Zhenghao CAI, MD +862164458887 c3z2h1@alumni.sjtu.edu.cn

Locations
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China, Shanghai
Ruijin hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Zhenghao Cai, MD    +8617316533505    c3z2h1@alumni.sjtu.edu.cn   
Sponsors and Collaborators
Shanghai Minimally Invasive Surgery Center
Tracking Information
First Submitted Date May 2, 2019
First Posted Date May 3, 2019
Last Update Posted Date April 6, 2021
Actual Study Start Date October 20, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019) 		metastasis rate [ Time Frame: an average of 1 year ]
metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 2, 2019)
  • lymphadenectomy time [ Time Frame: an average of 1 year ]
    time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
  • intraoperative complication [ Time Frame: an average of 1 year ]
    intraoperative complication
  • postoperative complication [ Time Frame: an average of 1 year ]
    postoperative complication
  • 3-year DFS [ Time Frame: an average of 3 years ]
    3-year disease free survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer
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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in Shanghai Minimally Invasive Surgery Center
Condition Colorectal Neoplasm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019) 		427
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2025
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zhenghao CAI, MD +862164458887 c3z2h1@alumni.sjtu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03936530
Other Study ID Numbers MISC- Infrapyloric LNM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Shanghai Minimally Invasive Surgery Center
Study Sponsor Shanghai Minimally Invasive Surgery Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Shanghai Minimally Invasive Surgery Center
Verification Date April 2021

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