Evidence map›Paper›PMID 37474823›Full record

Trial reportSurgical endoscopy2023

Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery.

Matthew Albert, Leticia Delgado-Herrera, Jennifer Paruch, Pauline Gerritsen-van Schieveen, Tomoyoshi Kishimoto, Shin Takusagawa, Na Cai, John Fengler, Jeffrey Raizer

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC 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. It is linked to trial NCT04238481 (A Phase 2 Randomized Open-label, Dose-ranging Study for Ureter Visualization Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT04238481 phase2completednot on this map

A Phase 2 Randomized Open-label, Dose-ranging Study for Ureter Visualization Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

TypeinterventionalSponsorAstellas Pharma IncRan2020 to 2021Enrolled13ConditionsLaparoscopic/Minimally Invasive Colorectal SurgeryArmsPudexacianinium chloride
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
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

9 authors at 6 institutions in 4 countries.

Matthew AlbertDepartment of Colorectal Surgery, Advent Health, 2415 N Orange Ave Ste 300, Orlando, FL, 32804, USA. Matthew.Albert.MD@AdventHealth.com.
Leticia Delgado-HerreraAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Jennifer ParuchOchsner Health, New Orleans, LA, USA.
Pauline Gerritsen-van SchieveenAstellas Pharma Europe B.V., Leiden, The Netherlands.
Tomoyoshi KishimotoAstellas Pharma, Inc., Tokyo, Japan.
Shin TakusagawaAstellas Pharma, Inc., Tokyo, Japan.
Na CaiAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
John FenglerStryker, Burnaby, BC, Canada.
Jeffrey RaizerAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Astellas Pharma (United States) · USAstellas Pharma (Japan) · JPAdventHealth Orlando · USAstellas Pharma (Netherlands) · NLOchsner Health System · USStryker (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients.

methodsIn this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed.

resultsParticipants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24-69) and median BMI was 29.3 kg/m

conclusionsIn this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

Indexed as

Colorectal NeoplasmsColorectal SurgeryLaparoscopyUreterAdultAgedChildChloridesFemaleFluorescent DyesHumansIndocyanine GreenMaleMiddle AgedYoung AdultChloridesFluorescent DyesIndocyanine GreenColorectal surgeryFluorescent dyesIndocyanine greenLaparoscopyNear-infrared fluorescencePudexacianinium

Identifiers

PMID37474823
PMCPMC10462524
OpenAlexW4384923866

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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.