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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Clinicaltrials.gov identifier NCT03936530

Recruitment Status Not yet recruiting

First Posted May 3, 2019

Last update posted May 3, 2019

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
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated 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
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: August 2020
  • Estimated Study Completion Date: August 2023
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
  • Ages Eligible for Study: 18 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

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

Locations
Sponsors and Collaborators

Shanghai Minimally Invasive Surgery Center

More Information
  • Responsible Party: Shanghai Minimally Invasive Surgery Center
  • ClinicalTrials.gov Identifier: NCT03936530 History of Changes
  • Other Study ID Numbers: MISC- Infrapyloric LNM
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • 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: Neoplasm Metastasis Colorectal Neoplasms