Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
Purpose
This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging.
Condition
- Adrenalectomy
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator adrenalectomy with indocyanine green imaging |
robotic adrenalectomy with intraoperative indocyanine green imaging |
|
|
No Intervention conventional adrenalectomy |
conventional robotic adrenalectomy without intraoperative indocyanine green imaging |
|
Recruiting Locations
Cleveland, Ohio 44195
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.