Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
adrenalectomy with indocyanine green imaging
robotic adrenalectomy with intraoperative indocyanine green imaging
  • Procedure: indocyanine green imaging
    intraoperative use of indocyanine green imaging during robotic adrenalectomy
No Intervention
conventional adrenalectomy
conventional robotic adrenalectomy without intraoperative indocyanine green imaging

Recruiting Locations

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Chaise Brewer
216-672-2131
brewerc3@ccf.org

More Details

Status
Recruiting
Sponsor
The Cleveland Clinic

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.