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Inferior Epigastric Lymph Node in Colorectal Carcinosis (EpiLyPath)

Primary Purpose

Colorectal Carcinomatosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Epigastric lymph node biopsy
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Carcinomatosis focused on measuring Epigastric lymph node, Cytoreductive surgery

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Jules Bordet InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients planned for complete cytoreductive surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

to define the risk for IELN invasion according to the mapping of PM
evaluation of the proportion of invaded IELN
to evaluate the predictive value of preoperative imaging for IELN invasion
comparison of imaged IELN and pathological analysis

Full Information

First Posted
June 14, 2021
Last Updated
October 3, 2023
Sponsor
Jules Bordet Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04966715
Brief Title
Inferior Epigastric Lymph Node in Colorectal Carcinosis
Acronym
EpiLyPath
Official Title
Inferior Epigastric Lymph Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Colorectal Peritoneal Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Colorectal cancer is a leading cause of cancer-related mortality worldwide. Twenty percent of the patients with CRC develop distant metastases. Among them, 50% have liver metastases (LM) and 25% have peritoneal metastases (PM). Half of these metastatic patients will present with liver-only hepatic metastases (HM) and a quarter will have just peritoneal metastases (PM). The peritoneum representing the second metastatic site in frequency. Patients with colorectal PM have a dismal prognosis in comparison with other metastatic sites. For patients with limited resectable peritoneal disease, surgery remains the only potentially curative option. The two major prognostic factors in patients undergoing cytoreductive surgery (CRS) for PM are the extent of the disease, as evaluated by the peritoneal cancer index (PCI) and the completeness of the resection. In patients undergoing complete macroscopic CRS, the 5-years overall survival (OS) is up to 45% in patients with a PCI <6, whereas OS falls to just 9% when PCI is >19. At the present time, however, only a minority (16%) of the patients who undergo surgery with a curative-intent for PM are cured, as indicated by disease-free survival (DFS) >10-years. Despite an aggressive combined approach (surgery and chemotherapy), most of these patients will die from loco-regional and/or systemic recurrence. This emphasizes the needs for a better characterization of the disease and for identification of more accurate selection criteria for surgery. Very few studies have explored the pathophysiological mechanisms of PM development and progression. The main mechanism of reported peritoneal dissemination that has been reported is a stepwise dissemination including the exfoliation of tumoral cells from the primary tumour into the peritoneal cavity. The pathophysiological mechanisms underlying systemic dissemination in patients presenting with PM are also poorly understood. The most well-known lymphatic dissemination pathways from the peritoneum into supra-diaphragmatic lymph nodes (LNs) are the retroperitoneal lymphatic pathway and the cardio-phrenic LNs. The presence of involved cardio-phrenic LNs is predictive of PM involvement. However, detection of these LNs is based on imaging that has a limited sensitivity (65%) and surgical access requires the opening of the diaphragm. Recently, the investigators reported, for the first time, a new lymphatic route of systemic dissemination of colorectal PM. The investigators reported LN metastases in the inferior epigastric LN basin (IELN). In this series, metabolic and morphologic imaging were not able to preoperatively predict the status of IELN. These LNs represent potential predictive factors of survival in patients treated for colorectal PM. The advantage of this LN basin is its easy surgical access that allows resection without increasing postoperative complications. The exact conditions for dissemination in IELN and their prognostic role remain undetermined. The primary objective of this study is to evaluate the incidence of IELN basin involvement in patients with colorectal PM undergoing complete CRS. The secondary objectives are to evaluate the capacity of preoperative imaging to detect these lesions and to define conditions for IELN involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinomatosis
Keywords
Epigastric lymph node, Cytoreductive surgery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients planned for complete cytoreductive surgery
Arm Type
Experimental
Arm Description
Only one arm in the study. All patients operated for complete cytoreductive surgery and who signed informed consent form
Intervention Type
Procedure
Intervention Name(s)
Epigastric lymph node biopsy
Intervention Description
epigastric lymph node biopsy and analysis to evaluate rate dissemination of colorectal carcinomatosis by this way
Primary Outcome Measure Information:
Title
to evaluate the incidence of IELN basin invasion in patients with CRPM undergoing complete CRS (CCR-0)
Description
collection and analysis of IELN basin
Time Frame
2 years
Secondary Outcome Measure Information:
Title
to define the risk for IELN invasion according to the mapping of PM
Description
evaluation of the proportion of invaded IELN
Time Frame
2 years
Title
to evaluate the predictive value of preoperative imaging for IELN invasion
Description
comparison of imaged IELN and pathological analysis
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will undergo complete cytoreductive surgery for peritoneal metastases from colorectal origin Patients with complete cytoreductive resection (R1) and a PCI< 20 Exclusion Criteria: Minor patients Patients unable to give written informed consent Previous surgery for colorectal cancer with iliac lymphadenectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine El Asmar, MD
Phone
+322541
Ext
3670
Email
antoine.el.asmar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Liberale, MD
Phone
+322541
Ext
3670
Email
gabriel.liberale@hubruxelles.be
Facility Information:
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine El Asmar, MD
Phone
+322541
Ext
3670
Email
antoine.el.asmar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Inferior Epigastric Lymph Node in Colorectal Carcinosis

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