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FALCON: a Multicenter Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02558556
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Cholecystolithiasis Cholecystitis Device: Laparoscopic Fluorescence Imaging System (Karl Storz) Other: Indocyanine Green Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Near-infrared Fluorescence Cholangiography Assisted Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy (FALCON): a Multicenter Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIRF-LC

This group of patients will undergo near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy by use of a Laparoscopic Fluorescence Imaging System (Karl Storz), in combination with one intravenous injection of contrast agent ICG. The ICG is given directly after induction of anesthesia in a dose of 1 ml of 2,5 mg/ml solution.

Intraoperatively every 2-5 minutes (more often if desired by surgeon) camera is switched to ICG mode for fluorescence cholangiography, until CVS is established.

Registration of time until establishment of CVS, visualization of the individual structures as described as secondary endpoints, and total operation time will be done.

The complete procedure will be recorded on video.

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.
Other Name: ICG

No Intervention: CLC

This group will undergo conventional laparoscopic cholecystectomy as in standard practice with no other intervention.

Registration of time until establishment of CVS, visualization of the individual structures as described as secondary endpoints, and total operation time will be done.

The complete procedure will be recorded on video.

Postoperatively, as in the NIRF-LC arm, the videos will be analysed to determine whether CVS is actually established, is the transition of the cystic duct into the gallbladder visualized? Is transition of the cystic artery into the gallbladder visualized? Furthermore, cost-minimalisation will be calculated.




Primary Outcome Measures :
  1. time to identification of CVS [ Time Frame: at time of surgery ]
    change in time to identification of CVS


Secondary Outcome Measures :
  1. time until identification of the transition of the cystic duct in the gallbladder during dissection of CVS [ Time Frame: at time of surgery ]
    change in time to identification

  2. visualization of CVS and visualization of the transition of the cystic duct and cystic artery in the gallbladder [ Time Frame: at time of surgery ]
    Are these structures actually visualized?

  3. total surgical time [ Time Frame: at time of surgery ]
    change in duration of surgery

  4. intraoperative bile leakage from the gallbladder or cystic duct [ Time Frame: at time of surgery ]
    change in number of intraoperative bile leakage from the gallbladder or cystic duct

  5. bile duct injury [ Time Frame: up to 90 days ]
    change in number of bile duct injuries

  6. postoperative length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days ]
    change in length of hospital stay

  7. complications due to the injected contrast agent [ Time Frame: at time of surgery ]
    appearance of complications in intervention group

  8. conversion to open cholecystectomy [ Time Frame: at time of surgery ]
    change in number of conversions

  9. postoperative complications [ Time Frame: up to 90 days ]
    change in number of postoperative complications

  10. cost-minimisation: difference in costs between the treatment in both groups [ Time Frame: up to 90 days ]
    change in costs per patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • iv Heparin injection in the last 24 h; (LMWH not contraindicated)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558556


Contacts
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Contact: Jacqueline van den Bos, MD 0031613206302 jacqueline.vanden.bos@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229
Contact: Jacqueline van den Bos, MD    0031613206302    jacqueline.vanden.bos@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Laurents PS Stassen, MD, PhD Maastricht UMC

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02558556     History of Changes
Other Study ID Numbers: NL47718.068.14
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

Keywords provided by Maastricht University Medical Center:
Laparoscopic cholecystectomy (LC)
Indocyanine green (ICG)
Near-Infrared Fluorescence Imaging (NIRF)
Critical View of Safety (CVS)

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystolithiasis
Cholelithiasis
Gallstones
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical