European Multicenter Study on Role of Lymph Node Dissection in Surgical Management of Adrenal Cortical Carcinoma (LACC)

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).

Study Overview

• Status: Recruiting
• Conditions: Adrenocortical Carcinoma
• Intervention / Treatment: Procedure: Adrenalectomy with or without lymphadenectomy

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Francesco Pennestrì, Dr; Phone Number: +393280244528; Email: francesco.pennestri@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Francesco Pennestrì, Dr; Phone Number: +393280244528; Email: francesco.pennestri@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with final histology of adrenocortical carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021

Description

Inclusion Criteria: All adult (18 years old and older) patients that underwent surgery with a final histology of adrenocortical carcinoma from 2015 till 2021

Inclusion Criteria:

• All adult (18 years old and older) patients
• underwent surgery
• final histology of adrenocortical carcinoma
• among European centers that participate in the Eurocrine® database between 2015 and 2021

Exclusion Criteria:

• Patients <18 years old
• Patients with metastatic disease at time of clinical referral

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adrenalectomy in patients operated for Adrenocortical Carcinoma; All adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for adrenocortical carcinoma from 2015 till 2021 will be included	Procedure: Adrenalectomy with or without lymphadenectomy; Regarding lymphadenectomy extent, it will be described as locoregional or systematic depending on availability of data in the Eurocrine database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adrenocortical Carcinoma (ACC) among European endocrine centers	Identification of the number of patients who underwent adrenalectomy for diagnosis of ACC among European centers participating in the Eurocrine database	January 2015- January 2021
Extent of lymphadenectomy	Evaluation of the lymph node dissection extension (in terms of number of lymph nodes and nodal stations dissected during surgical treatment for ACC)	January 2015- January 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncologic outcomes	Descriptive analysis of oncologic outcome (in terms of disease recurrence, lymph node metastasis and their association to the tumour stage) in patients who underwent surgical treatment of ACC in European centers	January 2015- January 2021

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Marco Raffaelli, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lymphadenectomy; Adrenocortical Carcinoma; Eurocrine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Carcinoma; Adrenocortical Carcinoma
• Other Study ID Numbers: 5171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Reasonable requests will be evaluated by the Eurocrine Council

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No