FALCON: a Multicenter Randomized Controlled Trial

Summary

Rationale: Several clinical feasibility studies have shown the potential benefit of near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) for enhanced and earlier biliary anatomy visualization during laparoscopic cholecystectomy with the aim to reduce the number of vascular and biliary injuries. Although the incidence of injuries is low (0.7%), the impact on patients in terms of morbidity, quality of life and costs are dramatic. The Critical View of Safety (CVS) technique is regarded as the safety valve in conventional laparoscopic cholecystectomy (CLC). It is hypothesized that standard application of near-infrared fluorescence imaging during laparoscopic cholecystectomy can be useful to obtain establishment of CVS (at least 5 minutes) earlier and with more certainty regarding visualization when compared to conventional laparoscopic imaging alone.

Study design: A multicenter randomized controlled trial with two study arms. Patients scheduled for an elective laparoscopic cholecystectomy will be recruited and randomized at the outpatient clinic (n = 308 total). One group will undergo near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (NIRF-LC) and the other group will undergo conventional laparoscopic cholecystectomy (CLC).

Compared with standard care, patients in the NIRF-LC group have to receive one preoperative intravenous injection of ICG. This is the only additional minimally invasive action for the patient. Initially, patients participating in this study will not benefit from the application of NIRFC during the surgical procedure. The administration of ICG and the modified laparoscope itself are not related with any kind of additional risk for the patient.

Despite the encouraging results from several (pre)clinical feasibility studies, wide clinical acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due to the absence of reliable and validated clinical data. A randomized clinical study is desirable to assess the potential added value of the NIRF imaging technique during laparoscopic cholecystectomy. Strong evidence in favor of routine implementation of this new imaging technique during laparoscopic cholecystectomy, will probably lead to worldwide routine application of the NIRF technique. Therewith long term sustainability of this research project is guaranteed.

Conditions

• Cholecystolithiasis
• Cholecystitis

Interventions

DEVICE

Laparoscopic Fluorescence Imaging System (Karl Storz)

The Laparoscopic Fluorescence Imaging System (incl. laparoscope, light source, light cable) will supply the needs for near-infrared fluorescence imaging with ICG. The hypothesis is that this device will help in visualizing the anatomical structures such as the common bile duct, which are hard to visualize in white light due to the surrounding tissues.

OTHER

Indocyanine Green

Indocyanine Green will be injected intravenously as a contrast agent for the use of the Laparoscopic Fluorescence Imaging System.

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Laurents PS Stassen, MD, PhD · Maastricht UMC

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-12-31

Completion

2020-07-31

Countries

• Netherlands

Study Locations