Evidence map›Paper›PMID 37442913›Full record

Trial reportAnnals of surgical oncology2023

Impact of Indocyanine Green Fluorescence Imaging on Lymphadenectomy Quality During Laparoscopic Distal Gastrectomy for Gastric Cancer (Greeneye): An Adaptative, Phase 2, Clinical Trial.

Carlo Sposito, Marianna Maspero, Valeria Conalbi, Andrea Magarotto, Michele Altomare, Carlo Battiston, Paolo Cantù, Vincenzo Mazzaferro

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Carlo SpositoUpper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. carlo.sposito@istitutotumori.mi.it.ORCID http://orcid.org/0000-0002-2276-2669
Marianna MasperoUpper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Valeria ConalbiUpper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Andrea MagarottoGastroenterology and Digestive Endoscopy, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Michele AltomareDepartment of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Carlo BattistonUpper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Paolo CantùGastroenterology and Digestive Endoscopy, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Vincenzo MazzaferroUpper GI Surgery and HPB Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITUniversity of Milan · ITSapienza University of Rome · IT

Funding

Prometeo ONLUS Unrestricted grant
6 · The paper itself

Abstract

backgroundIndocyanine green (ICG)-guided lymphadenectomy using near-infrared visualization (NIR) may increase nodal yield during gastrectomy. The purpose of this study was to evaluate the clinical benefit of NIR visualization on the quality of D2 lymphadenectomy during laparoscopic distal gastrectomy.

methodsThis single-arm, open-label, Simon's two-stage, adaptive, phase 2 trial included patients who underwent laparoscopic distal gastrectomy for gastric adenocarcinoma. Endoscopic peritumoral injection of ICG was performed 24 ± 6 h before surgery. Intraoperatively, after standard D2 lymphadenectomy and specimen extraction, NIR was used for eventual completion lymphadenectomy. The primary endpoint was clinical benefit of NIR (i.e., at least one additional harvested station containing lymph nodes, with negative points for every harvested station with no lymph nodes at final pathology).

resultsWe enrolled 18 patients (61% female, median age 69 years). With NIR, an extra 23 stations were harvested: 9 contained no lymph nodes, 12 contained nonmetastatic lymph nodes, and 2 contained metastatic lymph nodes. The most commonly visualized station with NIR were station 6 (8 patients) and 1 (4 patients). The total number of harvested nodes per patient was 32 (interquartile range [IQR] 26-41), with a median of 1 (IQR 0-1) additional lymph node after NIR. Overall, seven (39%) patients had a clinical benefit from NIR, of which two (11%) had one metastatic lymph node harvested with NIR.

conclusionsNIR visualization improves the quality of D2 lymphadenectomy in distal gastrectomy for gastric cancer. Considering the limited improve in the number of harvested lymph nodes, its real oncological benefit is still questionable.

Indexed as

LaparoscopyStomach NeoplasmsAgedFemaleGastrectomyHumansIndocyanine GreenLymphatic MetastasisLymph Node ExcisionMaleOptical ImagingIndocyanine Green

Identifiers

PMID37442913
PMCPMC10506942
OpenAlexW4384206913

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.