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NCT Number: NCT07813247

Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Chaise Brewer

CONTACT

[email protected]

216-672-2131

Eren Berber

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients scheduled for robotic adrenalectomy

Exclusion criteria

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

Treatment and study plan

indocyanine green imaging

Procedure

intraoperative use of indocyanine green imaging during robotic adrenalectomy

Primary outcomes

  1. dissection time

    Time frame: intraoperative

    duration of time for adrenal dissection in robotic adrenalectomy

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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