Inferior Epigastric Lymph Node in Colorectal Carcinosis (EpiLyPath)

Inferior Epigastric Lymph Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Colorectal Peritoneal Metastases

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

Study Overview

• Status: Completed
• Conditions: Colorectal Carcinomatosis
• Intervention / Treatment: Procedure: Epigastric lymph node biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Jules Bordet Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients planned for complete cytoreductive surgery; Only one arm in the study. All patients operated for complete cytoreductive surgery and who signed informed consent form	Procedure: Epigastric lymph node biopsy; epigastric lymph node biopsy and analysis to evaluate rate dissemination of colorectal carcinomatosis by this way

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
to define the risk for IELN invasion according to the mapping of PM	evaluation of the proportion of invaded IELN	2 years
to evaluate the predictive value of preoperative imaging for IELN invasion	comparison of imaged IELN and pathological analysis	2 years

Collaborators and Investigators

• Sponsor: Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cytoreductive surgery; Epigastric lymph node
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: EpiLyPath

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No