Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04966715 |
| Other study ID # |
EpiLyPath |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2022 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Jules Bordet Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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
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.
