NCT04966715

Brief Summary

In this study, the investigators propose to systematically collect and analyse epigastric lymph nodes during complete cytureductive surgery in patients with colorectal carcinomatosis, in order to define their role in the dissemination of colorectal metastases

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

June 14, 2021

Last Update Submit

February 22, 2024

Conditions

Colorectal Carcinomatosis

Keywords

Epigastric lymph nodeCytoreductive surgery

Outcome Measures

Primary Outcomes (1)

  • to evaluate the incidence of IELN basin invasion in patients with CRPM undergoing complete CRS (CCR-0)

    collection and analysis of IELN basin

    2 years

Secondary Outcomes (2)

  • to define the risk for IELN invasion according to the mapping of PM

    2 years

  • to evaluate the predictive value of preoperative imaging for IELN invasion

    2 years

Study Arms (1)

Patients planned for complete cytoreductive surgery

EXPERIMENTAL

Only one arm in the study. All patients operated for complete cytoreductive surgery and who signed informed consent form

Procedure: Epigastric lymph node biopsy

Interventions

Epigastric lymph node biopsyPROCEDURE

epigastric lymph node biopsy and analysis to evaluate rate dissemination of colorectal carcinomatosis by this way

Patients planned for complete cytoreductive surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo complete cytoreductive surgery for peritoneal metastases from colorectal origin
  • Patients with complete cytoreductive resection (R1) and a PCI\< 20

You may not qualify if:

  • Minor patients
  • Patients unable to give written informed consent
  • Previous surgery for colorectal cancer with iliac lymphadenectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, 1070, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

July 19, 2021

Study Start

February 3, 2022

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

February 23, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)