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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47297

Enrollment

205

Registered

2015-11-04

Start date

2016-02-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholecystolithiasis gall stones disease

Interventions

The NIRF-LC group will undergo near-infrared fluorescence cholangiography (in combination with one preoperative and one per-operative intravenous injection of contrast agent ICG) assisted laparoscop

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
Primary endpoint of this trial is: - "time to identification of CVS" This endpoint is used as a surrogate for bile duct identification without surgical exploration.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)