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Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

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ClinicalTrials.gov Identifier: NCT03936530
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Minimally Invasive Surgery Center

Study Description
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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
Groups and Cohorts
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Outcome Measures
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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
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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): NCT03936530


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
More Information
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Responsible Party: Shanghai Minimally Invasive Surgery Center
ClinicalTrials.gov Identifier: NCT03936530    
Other Study ID Numbers: MISC- Infrapyloric LNM
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Minimally Invasive Surgery Center:
colon adenocarcinoma
lymph node metastasis
right hemi-colectomy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Colorectal Neoplasms
Lymphatic Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases