Colorectal CarcinomatosisEpiLyPathNCT04966715
Inferior Epigastric Lymph Node in Colorectal Carcinosis
A study testing Epigastric lymph node biopsy in people with Colorectal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Carcinomatosis
- 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
- 3 Feb 2022to 31 Jan 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo complete cytoreductive surgery for peritoneal metastases from colorectal origin
- Patients with complete cytoreductive resection (R1) and a PCI< 20
Who cannot join
- Minor patients
- Patients unable to give written informed consent
- Previous surgery for colorectal cancer with iliac lymphadenectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Colorectal Carcinomatosis
- Being tested
- Epigastric lymph node biopsy
- Keywords
- Epigastric lymph node, Cytoreductive surgery
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 colorectal carcinomatosis by this way
| Study group | Role | What they receive |
|---|---|---|
| Patients planned for complete cytoreductive surgery | Experimental | 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.
to evaluate the incidence of IELN basin invasion in patients with CRPM undergoing complete CRS (CCR-0)
collection and analysis of IELN basin
Measured: 2 years
Secondary outcomes (2)
to define the risk for IELN invasion according to the mapping of PM
evaluation of the proportion of invaded IELN
Measured: 2 years
to evaluate the predictive value of preoperative imaging for IELN invasion
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 posted19 Jul 2021
- Study start3 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomatosisStudies 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
- Basic science
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966715
- Sponsor's protocol ID
- EpiLyPath
- Acronym
- EpiLyPath
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Epigastric Lymph Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Colorectal Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT04966715
- Acronym / sponsor ID
- EpiLyPath / EpiLyPath
- Conditions
- Colorectal Carcinomatosis
- Keywords
- Epigastric lymph node, Cytoreductive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Jul 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients planned for complete cytoreductive surgery | Experimental | Procedure: Epigastric lymph node biopsyOnly one arm in the study. All patients operated for complete cytoreductive surgery and who signed informed consent form |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo complete cytoreductive surgery for peritoneal metastases from colorectal origin
- Patients with complete cytoreductive resection (R1) and a PCI< 20
Key exclusion criteria (3 listed)
- Minor patients
- Patients unable to give written informed consent
- Previous surgery for colorectal cancer with iliac lymphadenectomy
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 colorectal carcinomatosis by this way | Procedure or surgery | Patients planned for complete cytoreductive surgery |
Primary outcome
to evaluate the incidence of IELN basin invasion in patients with CRPM undergoing complete CRS (CCR-0)
Time frame: 2 years
collection and analysis of IELN basin
2 secondary outcomes
to define the risk for IELN invasion according to the mapping of PM
Time frame: 2 years
to evaluate the predictive value of preoperative imaging for IELN invasion
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 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Carcinomatosis, 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 2 inclusion and 3 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 23 Feb 2024. 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?
to evaluate the incidence of IELN basin invasion in patients with CRPM undergoing complete CRS (CCR-0) (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 23 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.