NCT03936530

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2019Aug 2026

First Submitted

Initial submission to the registry

May 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

May 2, 2019

Last Update Submit

March 5, 2024

Conditions

Keywords

colon adenocarcinomalymph node metastasisright hemi-colectomy

Outcome Measures

Primary Outcomes (1)

  • metastasis rate

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

    an average of 1 year

Secondary Outcomes (4)

  • lymphadenectomy time

    an average of 1 year

  • intraoperative complication

    an average of 1 year

  • postoperative complication

    an average of 1 year

  • 3-year DFS

    an average of 3 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in Shanghai Minimally Invasive Surgery Center

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Yalikun A, Cai Z, Hong HJ, Dai K, Li S, Kwan W, Ma J, Feng B, Lu A, Zheng M, Zang L. Infrapyloric (No. 206) and greater curvature (No. 204) lymph node metastasis in adenocarcinoma located in the right half of the transverse colon (InCLART Study): protocol for a multicentre prospective observational study. BMJ Open. 2023 Feb 21;13(2):e066981. doi: 10.1136/bmjopen-2022-066981.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 3, 2019

Study Start

October 20, 2019

Primary Completion

August 1, 2023

Study Completion (Estimated)

August 1, 2026

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations