CRISAL Study:Cancer Risk In Secreting Adrenal Lesions

NCT06520111 | Recruiting DMC

• 1 other identifier: CRISAL (4051 CESC)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to report the cancer risk in secreting adrenal lesions. Secondary aims: to compare the incidence of cancer in secreting versus non-secreting adrenal lesions, in order to evaluate whether adrenal hormone activity can be considered an independent predictive indicator of malignancy; compare intraoperative and 30-day postoperative outcomes of patients undergoing adrenalectomy for secreting adrenal lesions versus non-secretoring lesions; regardless of the type of adrenal lesion, identify if there is one MIS adrenal approach that is superior to the others in terms of intra- and postoperative outcomes.

Conditions

Adrenal Tumor; Adrenal Incidentaloma; Surgery

Keywords

cancer risk; adrenal surgery; secreting adrenal lesions

Outcome Measures

Primary Outcomes (1)

• Cancer risk in secreting adrenal lesions.

  Number of patients who underwent adrenalectomy for secreting adrenal lesion which later proved to be malignant at definitive histological examination. This variable will be estimated as absolute and relative frequency and percentage value

  From July to December 2024

Secondary Outcomes (3)

• Cancer risk in secreting versus non-secreting adrenal lesions

  From July to December 2024

• Intraoperative and postoperative outcomes of patients undergoing adrenalectomy for secreting adrenal lesions versus non-secreting lesions

  From July to December 2024

• Intraoperative and postoperative outcomes in different minimally invasive adrenalectomies

  From July to December 2024

Study Arms (2)

patients underwent surgery for secreting adrenal lesion

patients underwent surgery for non- secreting adrenal lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an ambispective (retrospective and prospective) multicentre observational study. It will based on the consecutive enrollment of all patients aged 18 years or over undergoing elective adrenalectomy, after the acceptance of informed consent. For the primary aim of the study, only patients affected by secreting adrenal lesion will be considered and the incidence of cancer will be established on the basis of the definitive histology. For the further aims of the study, all enrolled patients will be divided into: patients with secreting adrenal lesions and patients with non-secreting adrenal lesions. Both groups will be stratified on the basis of definitive histology (malignant/benign) in order to identify the incidence of cancer for each group, the results will then be compared within and postoperative at 30 days.

You may qualify if:

• Patients undergoing elective adrenalectomy;
• Patients aged ≥ 18 years
• Acceptance of informed consent

You may not qualify if:

• Patients undergoing emergency adrenalectomy;
• Patients aged ≤ 18 years
• Pregnant patients

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

General and Mininvasive Surgery Department, Pederzoli Hospital,

Peschiera del Garda, Verona, Italy., Italy

RECRUITING

Related Publications (10)

• Fassnacht M, Johanssen S, Quinkler M, Bucsky P, Willenberg HS, Beuschlein F, Terzolo M, Mueller HH, Hahner S, Allolio B; German Adrenocortical Carcinoma Registry Group; European Network for the Study of Adrenal Tumors. Limited prognostic value of the 2004 International Union Against Cancer staging classification for adrenocortical carcinoma: proposal for a Revised TNM Classification. Cancer. 2009 Jan 15;115(2):243-50. doi: 10.1002/cncr.24030.

  PMID: 19025987 BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Birsen O, Akyuz M, Dural C, Aksoy E, Aliyev S, Mitchell J, Siperstein A, Berber E. A new risk stratification algorithm for the management of patients with adrenal incidentalomas. Surgery. 2014 Oct;156(4):959-65. doi: 10.1016/j.surg.2014.06.042.

  PMID: 25239353 BACKGROUND

• Stefanidis D, Goldfarb M, Kercher KW, Hope WW, Richardson W, Fanelli RD; Society of Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for minimally invasive treatment of adrenal pathology. Surg Endosc. 2013 Nov;27(11):3960-80. doi: 10.1007/s00464-013-3169-z. Epub 2013 Sep 10. No abstract available.

  PMID: 24018761 BACKGROUND

• Kazaure HS, Sosa JA. Volume-outcome relationship in adrenal surgery: A review of existing literature. Best Pract Res Clin Endocrinol Metab. 2019 Oct;33(5):101296. doi: 10.1016/j.beem.2019.101296. Epub 2019 Jul 12.

  PMID: 31331729 BACKGROUND

• undefined

  BACKGROUND

• Bergamini C, Martellucci J, Tozzi F, Valeri A. Complications in laparoscopic adrenalectomy: the value of experience. Surg Endosc. 2011 Dec;25(12):3845-51. doi: 10.1007/s00464-011-1804-0. Epub 2011 Jun 17.

  PMID: 21681621 BACKGROUND

• Kahramangil B, Kose E, Remer EM, Reynolds JP, Stein R, Rini B, Siperstein A, Berber E. A Modern Assessment of Cancer Risk in Adrenal Incidentalomas: Analysis of 2219 Patients. Ann Surg. 2022 Jan 1;275(1):e238-e244. doi: 10.1097/SLA.0000000000004048.

  PMID: 32541223 BACKGROUND

• Balla A, Corallino D, Ortenzi M, Palmieri L, Meoli F, Guerrieri M, Paganini AM. Cancer risk in adrenalectomy: are adrenal lesions equal or more than 4 cm a contraindication for laparoscopy? Surg Endosc. 2022 Feb;36(2):1131-1142. doi: 10.1007/s00464-021-08380-7. Epub 2021 Mar 1.

  PMID: 33650006 BACKGROUND

• Castillo OA, Vitagliano G, Secin FP, Kerkebe M, Arellano L. Laparoscopic adrenalectomy for adrenal masses: does size matter? Urology. 2008 Jun;71(6):1138-41. doi: 10.1016/j.urology.2007.12.019. Epub 2008 Mar 12.

  PMID: 18336879 BACKGROUND

Related Links

• SICE website

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Adrenal incidentaloma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Diletta D Corallino

CONTACT

+39-3888592412; diletta.corallino1989@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; M.D; PhD student

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 25, 2024
• Study Start: August 27, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 10, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From January to December 2024
• Access Criteria: All researchers will be involved in the IPD management through SICE (Società di chirurgia endoscopica e nuove tecnologie)

Locations

IT (1)