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Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging

Randomized Prospective Study of Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07813247
Enrollment
55
Registered
2026-09-10
Start date
2026-07-31
Completion date
2027-12-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenalectomy

Brief summary

This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging.

Detailed description

Identification of the adrenal gland intraoperatively is critical to get in to the correct surgical plane and perform minimally invasive adrenalectomy with clear margins and without causing excessive bleeding. Intraoperative ultrasound has been used traditionally, but suffers from air artefact when there is insufficient contact between the tissue and the ultrasound probe. Furthermore, intraoperative ultrasound requires interruption of the procedure for the ultrasound, prolonging operative time and may not be possible when the dissection plane deepens. Indocyanine green (ICG) fluorescence has emerged over the past few years as a new intraoperative imaging modality. As ICG fluorescence is directly related to the perfusion of tissues and the adrenal gland has one of the highest blood supplies among organs in the abdomen, the adrenalectomy is a perfect application of this technology. Our group, as well as others, have described the safety and feasibility of ICG fluorescence imaging during robotic adrenalectomy over the last decade, however, whether the use of this imaging creates an impact of robotic adrenalectomy on intraoperative and perioperative outcomes is unknown, as no randomized study has been done on this topic. It is unknown if intraoperative ICG imaging improves outcomes compared to conventional adrenalectomy that does not use this imaging. Based on our retrospective experience, ICG-guided adrenalectomy may facilitate dissection part of the procedure and hence shorten operative time by providing a road map regarding the dissection planes in different steps of the operation. So, the hypothesis of the study is that ICG imaging may shorten the dissection step of minimally invasive adrenalectomy.

Interventions

PROCEDUREindocyanine green imaging

intraoperative use of indocyanine green imaging during robotic adrenalectomy

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients scheduled for robotic adrenalectomy

Exclusion criteria

* patients scheduled for laparoscopic or open adrenalectomy or with an iodine allergy

Design outcomes

Primary

MeasureTime frameDescription
dissection timeintraoperativeduration of time for adrenal dissection in robotic adrenalectomy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026