Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Sponsor
Shanghai Minimally Invasive Surgery Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03936530
Collaborator
(none)
427
Enrollment
1
Location
65.4
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    427 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 :
    Oct 20, 2019
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. metastasis rate [an average of 1 year]

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

    Secondary Outcome Measures

    1. lymphadenectomy time [an average of 1 year]

      time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node

    2. intraoperative complication [an average of 1 year]

      intraoperative complication

    3. postoperative complication [an average of 1 year]

      postoperative complication

    4. 3-year DFS [an average of 3 years]

      3-year disease free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Ruijin hospitalShanghaiShanghaiChina200025

    Sponsors and Collaborators

    • Shanghai Minimally Invasive Surgery Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Minimally Invasive Surgery Center
    ClinicalTrials.gov Identifier:
    NCT03936530
    Other Study ID Numbers:
    • MISC- Infrapyloric LNM
    First Posted:
    May 3, 2019
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2021