Actively Recruiting

Age: 18Years +
All Genders
ID06520111

CRISAL Study: Cancer Risk in Secreting Adrenal Lesions and Surgical Outcomes

Led by University of Roma La Sapienza · Updated on 2024-08-30

300

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 study's 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

Brief Title

CRISAL Study:Cancer Risk In Secreting Adrenal Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective adrenalectomy
  • Patients aged 18 years or older
  • Acceptance of informed consent
Not Eligible

You will not qualify if you...

  • Patients undergoing emergency adrenalectomy
  • Patients younger than 18 years
  • Pregnant patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

General and Mininvasive Surgery Department, Pederzoli Hospital,

Peschiera del Garda, Verona, Italy., Italy

Actively Recruiting

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Research Team

D

Diletta D Corallino

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Limited prognostic value of the 2004 International Union Against Cancer staging classification for adrenocortical carcinoma: proposal for a Revised TNM Classification.

Martin Fassnacht, Sarah Johanssen, Marcus Quinkler...

https://pubmed.ncbi.nlm.nih.gov/19025987

Cancer risk in adrenalectomy: are adrenal lesions equal or more than 4 cm a contraindication for laparoscopy?

Andrea Balla, Diletta Corallino, Monica Ortenzi...

https://pubmed.ncbi.nlm.nih.gov/33650006