Evidence map›Paper›PMID 31311922›Full record

Trial reportNature communications2019

A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery.

Kim S de Valk, Henricus J Handgraaf, Marion M Deken, Babs G Sibinga Mulder, Adrianus R Valentijn, Anton G Terwisscha van Scheltinga, Joeri Kuil, Michiel J van Esdonk, Jaap Vuijk, Rob F Bevers and 5 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled TrialVideo-Audio Media
In one paragraph

Trial report in Nature communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% of its field
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.

NCT06101745 phase2 / phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Phase 2/3 Randomized Controlled Semi-blinded Trial to Investigate Safety and Effectiveness in Ureter Visualization With Intravenous Nizaracianine Triflutate, in up to 3 Divided Doses, in Adults Undergoing Abdominopelvic Surgery (TRIPHASE)

TypeinterventionalSponsorCuradel Surgical Innovations, Inc.Ran2024 to 2026Enrolled336ConditionsInjury of Ureter During Surgery (Disorder)ArmsNizaracianine Triflutate, Placebo Comparator
NCT06535555 nawithdrawnnot on this mapstarted 2023, after this paper: background citation

Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence

TypeinterventionalSponsorActiv SurgicalRan2023 to 2023Enrolled0ConditionsSurgical Procedure, UnspecifiedArmsInvestigational Safety and Feasibility
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

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  16. Normalization of Time-Intensity Curves for Quantification of Foot Perfusion Using Near-Infrared Fluorescence Imaging With Indocyanine Green.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2023
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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 at 3 institutions in 2 countries.

Kim S de ValkCentre for Human Drug Research, Leiden, The Netherlands. k.s.de_valk@lumc.nl.
Henricus J HandgraafLeiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5114-3584
Marion M DekenLeiden University Medical Center, Leiden, The Netherlands.
Babs G Sibinga MulderLeiden University Medical Center, Leiden, The Netherlands.
Adrianus R ValentijnLeiden University Medical Center, Leiden, The Netherlands.
Anton G Terwisscha van ScheltingaLeiden University Medical Center, Leiden, The Netherlands.
Joeri KuilLeiden University Medical Center, Leiden, The Netherlands.
Michiel J van EsdonkCentre for Human Drug Research, Leiden, The Netherlands.
Jaap VuijkLeiden University Medical Center, Leiden, The Netherlands.
Rob F BeversLeiden University Medical Center, Leiden, The Netherlands.
Koen C PeetersLeiden University Medical Center, Leiden, The Netherlands.
Fabian A HolmanLeiden University Medical Center, Leiden, The Netherlands.
John V FrangioniCuradel, LLC, Marlborough, MA, USA.
Jacobus BurggraafCentre for Human Drug Research, Leiden, The Netherlands.
Alexander L VahrmeijerLeiden University Medical Center, Leiden, The Netherlands.
Leiden University Medical Center · NLCentre for Human Drug Research · NLCuradel (United States) · US

Funding

ZW800-1: The 1st Zwitterionic NIR Fluorophore for Cancer Imaging & Ureter MappingR44CA210820 · NCI · CURADEL, LLC · PI FRANGIONI, JOHN V · 2017 to 2022
$6.0M
NCI NIH HHS R44 CA210820
6 · The paper itself

Abstract

Iatrogenic injury of the ureters is a feared complication of abdominal surgery. Zwitterionic near-infrared fluorophores are molecules with geometrically-balanced, electrically-neutral surface charge, which leads to renal-exclusive clearance and ultralow non-specific background binding. Such molecules could solve the ureter mapping problem by providing real-time anatomic and functional imaging, even through intact peritoneum. Here we present the first-in-human experience of this chemical class, as well as the efficacy study in patients undergoing laparoscopic abdominopelvic surgery. The zwitterionic near-infrared fluorophore ZW800-1 is safe, has pharmacokinetic properties consistent with an ideal blood pool agent, and rapid elimination into urine after a single low-dose intravenous injection. Visualization of structure and function of the ureters starts within minutes after ZW800-1 injection and lasts several hours. Zwitterionic near-infrared fluorophores add value during laparoscopic abdominopelvic surgeries and could potentially decrease iatrogenic urethral injury. Moreover, ZW800-1 is engineered for one-step covalent conjugatability, creating possibilities for developing novel targeted ligands.

Indexed as

AdolescentAdultAgedFemaleFluorescent DyesHealthy VolunteersHumansInfusions, IntravenousIntraoperative ComplicationsIonophoresLaparoscopyMaleMiddle AgedOptical ImagingQuaternary Ammonium CompoundsSpectroscopy, Near-InfraredFluorescent DyesIonophoresQuaternary Ammonium CompoundsSulfonic AcidsZW800-1 compound

Identifiers

PMID31311922
PMCPMC6635391
OpenAlexW2956322724

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.