ear-infrared Fluorescence Cholangiography assisted Laparoscopic Cholecystectomy versus Conventional Laparoscopic Cholecystectomy (FALCON): a multicenter randomized controlled trial

Completed

Conditions: cholecystolithiasis
gall stones disease
10017969
10017998

Registration Number: NL-OMON47297

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 205

Inclusion Criteria

Male and female patients, aged 18 years and above
Scheduled for elective laparoscopic cholecystectomy
Normal liver and renal function
No hypersensitivity for iodine or ICG
Able to understand nature of the study procedures
Willing to participate and with written informed consent
Physical Status Classification: ASA I / ASA II

Exclusion Criteria

Age < 18 years
Liver or renal insufficiency
Known iodine or ICG hypersensitivity
Pregnancy or breastfeeding
Not able to understand nature of the study procedure
Physical Status Classification: ASA III and above

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of this trial is:<br /><br>- time to identification of CVS<br /><br><br /><br>This endpoint is used as a surrogate for bile duct identification without<br /><br>surgical exploration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- time until identification of the transition of the cystic duct in the<br /><br>gallbladder during dissection of CVS;<br /><br>- visualization of CVS and visualization of the transition of the cystic duct<br /><br>and cystic artery in the gallbladder;<br /><br>- total surgical time;<br /><br>- intraoperative bile leakage from the gallbladder or cystic duct;<br /><br>- bile duct injury;<br /><br>- postoperative length of hospital stay;<br /><br>- complications due to the injected contrast agent;<br /><br>- conversion to open cholecystectomy.<br /><br>- postoperative complications (until 90 days after the surgical procedure)<br /><br>- cost-minimisation.</p><br>