A new risk stratification algorithm for the management of patients with adrenal incidentalomas.
Onur Birsen, Muhammet Akyuz, Cem Dural...
https://pubmed.ncbi.nlm.nih.gov/25239353/Actively Recruiting
Led by University of Roma La Sapienza · Updated on 2024-08-30
300
Participants Needed
1
Research Sites
5 weeks
Total Duration
Researchers are investigating the risk of cancer in patients with hormone-secreting adrenal lesions. The study also compares cancer rates between secreting and non-secreting adrenal lesions to see if hormone activity is an independent predictor of malignancy. Additionally, it examines the safety and outcomes of different minimally invasive surgical techniques for adrenalectomy in these patients. The study follows ethical guidelines and involves multiple centers. The study includes patients aged 18 and older who are undergoing elective adrenalectomy. It collects detailed information on patient history, lesion characteristics, surgical methods, and postoperative outcomes using a secure data platform. Patients are grouped by whether their adrenal lesions secrete hormones and by the type of surgical approach used, including various minimally invasive methods like laparoscopic and robotic surgery. Outcomes measured include intraoperative complications and 30-day postoperative results. Participants will have demographic data, preoperative evaluations, surgical details, and postoperative recovery recorded and analyzed. Researchers will assess cancer incidence based on histological examination and compare surgical approaches on safety and effectiveness. The studys primary outcome is cancer risk in secreting adrenal lesions, with follow-up during and after surgery. Participation involves data collection without experimental treatment, and the total study period includes both retrospective and prospective enrollment until late 2024.
CONDITIONS
CRISAL Study:Cancer Risk In Secreting Adrenal Lesions
D
Diletta D Corallino
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University of Roma La Sapienza
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay until discharge
Participants undergo elective adrenalectomy followed by immediate post-operative care to assess surgical outcomes and complications.
1 hospital stay with monitoring during admission
Duration - 30 days
Participants are followed for 30 days after surgery to monitor recovery, complications, and oncological outcomes.
Approximately 1 to 2 follow-up visits within 30 days
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor