Clinical trial · Observational
CRISAL Study:Cancer Risk In Secreting Adrenal Lesions
NCT06520111CI-TRIAL-00080345CRISALunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Incidentaloma | — | UNRESOLVED | — |
| Adrenal Tumor | Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- patients underwent surgery for secreting adrenal lesion
- label
- patients underwent surgery for non- secreting adrenal lesion
Primary outcomes (1)
- measure
- Cancer risk in secreting adrenal lesions.
- timeFrame
- From July to December 2024
- description
- 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
Secondary outcomes (3)
- measure
- Cancer risk in secreting versus non-secreting adrenal lesions
- timeFrame
- From July to December 2024
- description
- Comparison between the incidence of cancer in patients affected by secreting adrenal lesions VS patients affected by non-secreting adrenal lesions. These two groups will be matched based on other preoperative characteristics (comorbidities and pharmacological therapies, cancer history, lesion size and site, preoperative imaging and hormonal evaluation) to reduce potential bias Categorical variables will be estimated as absolute and relative frequency, while continuous variables as median (IQR interquartile range). Inferential statistics for categorical variables will be estimated by Fisher exact test, while those of continuous variables by Mann-Whitney and Kruskal-Wallis tests (for independent data) and Wilcoxon and Friedman tests (for repeated data).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing elective adrenalectomy; * Patients aged ≥ 18 years * Acceptance of informed consent Exclusion Criteria: Patients undergoing emergency adrenalectomy; * Patients aged ≤ 18 years * Pregnant patients
References
Publications (10)
- BACKGROUNDFassnacht 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
- BACKGROUNDCharlson 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
- BACKGROUNDBirsen 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
- BACKGROUNDStefanidis 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
- BACKGROUNDKazaure 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
- BACKGROUNDundefined
- BACKGROUNDBergamini 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