Inferior Epigastric Lymp Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Ovarian Peritoneal Metastases (OvEpiLyPath)

August 4, 2026 updated by: Jules Bordet Institute
The IELN basin could represent a primary LN relay for systemic metastatic dissemination in patients with OPM. This newly described lymphatic pathway of metastatic dissemination of OPM may be involved in certain presentations of peritoneal dissemination. The presence of invaded IELN may represent a new biomarker predictive of the pattern of progression of OPM and a related risk for systemic dissemination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

More than two thirds of all patients with epithelial ovarian carcinoma have an advanced stage III or IV at diagnosis. However, in select group of patients, particularly in those with low tumor volume, parietal and visceral peritonectomy with the aim of complete macroscopic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) is feasible and associated with a reasonable morbidity rate and mortality rate in patients with peritoneal carcinomatosis and ovarian cancer. The role of Peritoneal Cancer Index, expressing the tumor volume, was also found to be a prognostic indicator for the survival in these patients. A therapeutic approach that combined CRS + HIPEC could achieve long-term survival in selected groups of patients with ovarian peritoneal metastases (OPM) tumors with acceptable morbidity and mortality. A good expertise and a high volume of patients are necessary to manage PC and to further improve results.

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 PM. They 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 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 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.

Hypotheses of the research:

The IELN basin could represent a primary LN relay for systemic metastatic dissemination in patients with OPM. This newly described lymphatic pathway of metastatic dissemination of OPM may be involved in certain presentations of peritoneal dissemination. The presence of invaded IELN may represent a new biomarker predictive of the pattern of progression of OPM and a related risk for systemic dissemination.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who will undergo complete cytoreductive surgery for peritoneal metastases from ovarian origin

Exclusion Criteria:

  • Minor patients
  • Patients unable to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients

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 ovarian carcinomatosis by this way

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of IELN invasion by ovarian cancer
Time Frame: 2 years
Number of invaded lymph nodes in the inferior epigastric lymp node basin to evaluate the incidence of IELN invasion by ovarian cancer
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In cases of IELN positivity, review thoroughly preoperative scans and MRIs in order to detect radiological features, usually overlooked, that could help identify the positivity of these LNs prior to pathological analysis.
Time Frame: 2 years
comparison of imaged IELN and pathological analysis
2 years
proportion of invaded IELN lymph nodes
Time Frame: 2 years
Assess the incidence (in %) of IELN involvement with metastatic ovarian cancer, with respect to the patient's PCI and the peritoneal zones involved mostly by the disease (Sugarbaker zones), e.g. pelvic peritoneum versus flanks, versus upper abdominal quadrants.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Antoine El Asmar, MD, Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OvEpiLyPath

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe