Carcinomatosis, PeritonealOvEpiLyPathNCT06237582
Inferior Epigastric Lymp Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Ovarian Peritoneal Metastases
A study testing epigastric lymph node biopsy in people with Carcinomatosis, Peritoneal, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinomatosis, Peritoneal
- What is being tested?
- epigastric lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jun 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo complete cytoreductive surgery for peritoneal metastases from ovarian origin
Who cannot join
- Minor patients
- Patients unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carcinomatosis, Peritoneal
- Being tested
- epigastric lymph node biopsy
- Keywords
- epigastric lymph node, cytoreductive surgery, ovarian cancer
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epigastric lymph node biopsyProcedure or surgery
epigastric lymph node biopsy and analysis to evaluate rate dissemination of ovarian carcinomatosis by this way
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: epigastric lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
proportion of invaded IELN lymph nodes
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.
Measured: 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.
comparison of imaged IELN and pathological analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start16 Jun 2022
- Primary completion1 Jan 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomatosis, PeritonealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine El Asmar, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237582
- Sponsor's protocol ID
- OvEpiLyPath
- Acronym
- OvEpiLyPath
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Epigastric Lymp Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Ovarian Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT06237582
- Acronym / sponsor ID
- OvEpiLyPath / OvEpiLyPath
- Conditions
- Carcinomatosis, Peritoneal
- Keywords
- epigastric lymph node, cytoreductive surgery, ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Procedure: epigastric lymph node biopsypatients planned for complete cytoreductive surgery Only one arm in the study: all patients operated for complete cytoreductive surgery and who signed informed consent form |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo complete cytoreductive surgery for peritoneal metastases from ovarian origin
Key exclusion criteria (2 listed)
- Minor patients
- Patients unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epigastric lymph node biopsyepigastric lymph node biopsy and analysis to evaluate rate dissemination of ovarian carcinomatosis by this way | Procedure or surgery | patients |
Primary outcome
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 secondary outcomes
proportion of invaded IELN lymph nodes
Time frame: 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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine El Asmar, MD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epigastric lymph node biopsy in people with Carcinomatosis, Peritoneal, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IELN invasion by ovarian cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.