N/A
N=100
The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Cholelithiasis · Cholecystitis · Pancreatitis Biliary · Colic of Gallbladder Without Mention of Cholecystitis
Bottom Line
View on ClinicalTrials.gov: NCT01424215 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Operative Time — 51.6; 44.4 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indocyanine Green (ICG) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Maimonides Medical Center
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operative Time |
51.6; 44.4 | — |
| SECONDARY Identification of Structures |
17.1; 20.2 | — |
Summary
The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.
Eligibility Criteria
Inclusion Criteria
- Subject is willing and able to provide an informed consent
- Subject is willing and able to comply with the study procedures
- Subject speaks English and is able to understand the study procedures
- A pregnancy test for women of childbearing potential prior to surgery
- Subject is scheduled for laparoscopic cholecystectomy
Exclusion Criteria
- Subject has uremia, serum creatinine >2.5 mg/dl
- Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is a pregnant or lactating female
- Subject is actively participating in another drug, biologic and/or device protocol
Data sourced from ClinicalTrials.gov (NCT01424215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.