Evidence map›Paper›PMID 36849564›Full record

Trial reportSurgical endoscopy2023

Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial.

J van den Bos, R M Schols, L Boni, E Cassinotti, T Carus, M D Luyer, A L Vahrmeijer, J S D Mieog, N Warnaar, F Berrevoet and 5 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

J van den BosDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. j.vandenbos@student.maastrichtuniversity.nl.ORCID 0000-0001-6417-0330
R M ScholsDepartment of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
L BoniDepartment of Surgery, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Di Milano, Milan, Italy.
E CassinottiDepartment of Surgery, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Di Milano, Milan, Italy.
T CarusDepartment of Surgery, Asklepios West Klinikum, Hamburg, Germany.
M D LuyerDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
A L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
J S D MieogDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
N WarnaarDepartment of Surgery, Colchester General Hospital, Colchester, UK.
F BerrevoetDepartment of General and HPB Surgery and Liver Transplantation, University Hospital Ghent, Ghent, Belgium.
F van de GraafDepartment of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
J F LangeDepartment of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
S M J Van KuijkDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
N D BouvyDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
L P S StassenDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy.

methodsThis international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to 'Critical View of Safety' (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points.

resultsA total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG.

conclusionUse of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.

Indexed as

Biliary TractCholecystectomy, LaparoscopicCholangiographyCystic DuctHumansIndocyanine GreenIndocyanine Green

Identifiers

PMID36849564

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.