Real-time Intraoperative Near-Infrared Fluorescence Cholangiography Assisted Laparoscopic Cholecystectomy: A pilot study

Completed

Conditions: cholecystitis
gall stones
inflammation of the gall bladder
10017969
10017998

Registration Number: NL-OMON37688

Lead Sponsor: azM (academisch ziekenhuis Maastricht)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Patients scheduled for a laparoscopic cholecystectomy
Able to understand the nature of the study and what will be required of them
Males and females (not pregnant)
Age >18 years
Normal liver and renal function
No hypersensitivity for iodine
Willing to participate

Exclusion Criteria

Not able to give written informed consent
Liver or renal insufficiency
Iodine hypersensitivity
Pregnant women
Aged < 18 years
Not willing to participate

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Identification of biliary anatomy<br /><br>- Identification of critical view of safety<br /><br><br /><br>Assessment of NIRFC technique:<br /><br>- Video analysis<br /><br>- Intraoperative registration/evaluation form<br /><br>- Recognition of the biliary anatomy (at set time points: every 5-10 minutes)<br /><br>and moment of obtaining CVS<br /><br>- Speed and efficiency of the procedure<br /><br>- Safety of the procedure<br /><br><br /><br>Time measurement:<br /><br>- time until CVS is obtained<br /><br>- time until fluorescence/conventional imaging is obtained of individual<br /><br>biliary structures<br /><br>- total operating time<br /><br><br /><br>Later on, this can be compared to conventional laparoscopic cholecystectomy<br /><br>procedures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will register complications caused during the procedure:<br /><br>- Bile duct injury<br /><br>- Vascular injury<br /><br><br /><br>We will register unsuspected adverse effects of the administered fluorescent<br /><br>dye</p><br>