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Active, not recruitingNCT03936530Updated Mar 7, 2024

Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

An observational study in Colorectal Neoplasm, sponsored by Shanghai Minimally Invasive Surgery Center. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Shanghai Minimally Invasive Surgery Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
432
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasm

Keywords

  • colon adenocarcinoma
  • lymph node metastasis
  • right hemi-colectomy
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 432 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Shanghai Minimally Invasive Surgery Center is the lead sponsor of 29 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized in Shanghai Minimally Invasive Surgery Center

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
432 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. metastasis rate

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

    Time frame: an average of 1 year

Secondary outcomes

  1. lymphadenectomy time

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

    Time frame: an average of 1 year

  2. intraoperative complication

    intraoperative complication

    Time frame: an average of 1 year

  3. postoperative complication

    postoperative complication

    Time frame: an average of 1 year

  4. 3-year DFS

    3-year disease free survival

    Time frame: an average of 3 years

07

Study locations

1 site
  • Ruijin hospital
    Shanghai, Shanghai 200025, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03936530
Lead sponsor
Shanghai Minimally Invasive Surgery Center
Responsible party
Sponsor
First posted
May 3, 2019
Start date
Oct 20, 2019
Primary completion
Aug 1, 2023
Completion
Aug 1, 2026 (estimated)
Last update
Mar 7, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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