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

NCT06237582 | Completed

• 1 other identifier: OvEpiLyPath
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinomatosis, Peritoneal

Keywords

epigastric lymph node; cytoreductive surgery; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of IELN invasion by ovarian cancer

  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 Outcomes (2)

• proportion of invaded IELN lymph nodes

  2 years

• 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.

  2 years

Study Arms (1)

patients

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

Interventions

epigastric lymph node biopsy PROCEDURE

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Minor patients
• Patients unable to give written informed consent

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Antoine El Asmar, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: February 1, 2024
• Study Start: June 16, 2022
• Primary Completion: January 1, 2023
• Study Completion: September 30, 2023
• Last Updated: August 6, 2026

Record last verified: 2023-11

Locations

BE (1)