Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05763524 |
| Other study ID # |
5171 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
September 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Francesco Pennestri, Dr |
| Phone |
+393280244528 |
| Email |
francesco.pennestri[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This project will evaluate of the number of patients who underwent adrenalectomy for ACC in
different European centers using the EUROCRINE® database. The analysis will focus on the
extent of lymph nodal dissection (i.e. number of lymph nodes and nodal stations dissected
during adrenalectomy). We aim to evaluate the oncologic radicality of surgical treatment and
the rate of tumour recurrences after surgery and nodal metastasis related to the stage of the
disease and to tumour side (left/right).
Description:
Adrenocortical carcinoma (ACC) is a rare malignancy with an estimated annual incidence of
only 0.5 to 2.0 per million population and a high rate of mortality: Stage I, II and III 5
years-survival is respectively 84%, 63% and 24%, while medium survival is less than 12 months
for metastatic disease. Stage of the disease, age at diagnosis, tumour grading and complete
surgical resection are the main prognostic factors. Surgical treatment is the only effective
therapeutic strategy for ACC and recent guidelines recommend loco-regional lymph node
dissection as a fundamental surgical element in order to guarantee complete resection.
However, adrenal lymphatic drainage can be variable. The main collecting lymph nodes
representing the first tiers in the lymphatic drainage are the peri-adrenal nodes and the
renal ilum nodes. In addition, the posterior lymphatic drainage flows to lymph nodes located
posterior to the IVC, and on the right edge of the aorta for the right adrenal gland, or on
its right left edge for the left gland, stretching from the celiac region near the
diaphragmatic crus to the renal vessels.
The anterior lymphatic drainage flows downward to the lumboaortic nodes and ends in the
interaortocaval space, on the right edge of the aorta for the right adrenal gland, and on its
right left edge for the left gland and mainly around the renal hilum. Collecting nodes can be
located below the renal pedicle, sometimes extending as far as the origin of the iliac
vessel. Most authors concur in describing a lymphatic drainage that passes through the
diaphragm directly into the posterior mediastinal nodes. A majority of lymphatic channels run
medially to the thoracic duct, often without the involvement of any lymph nodes. Furthermore,
it is impossible to predict which pathway would be involved in case of a malignant lesion,
because all pathways would probably be involved simultaneously because of the size, often >10
cm, of ACC at diagnosis, and considering that the lymphatic stream can be disorganized
because of the tumour volume or lymph node involvement. Therefore, the extent of lymph node
dissection in order to involve other stations should be considered only on the basis of
pre-operative radiological evidence and intra-operative evaluation. Despite aggressive
surgical resection, local and distant recurrence rate after R0 surgery remains as high as
50-80%, potentially because of the lack of an accurate identification of the nodes stations
for the lymph node dissection. Indeed, nodes drain disorganization due to the high tumour
volume makes impossible to predict accurately the lymphatic metastatic pathway. In this
context, the rarity of ACC leads to heterogeneity of the scientific studies and consequently
to the lack of perspective works, so that tumour recurrence evaluation refers to patients
categories who underwent lymph node dissection with or without preoperative evidence of nodal
disease
