Evidence map›Paper›PMID 36153502›Full record

ArticleBMC pulmonary medicine2022

Systematic endoscopic staging of mediastinum to determine impact on radiotherapy for locally advanced lung cancer (SEISMIC): protocol for a prospective single arm multicentre interventional study.

Daniel P Steinfort, Shankar Siva, Kanishka Rangamuwa, Percy Lee, David Fielding, Phan Nguyen, Barton R Jennings, Shaun Yo, Nick Hardcastle, Gargi Kothari and 5 more

Open access · goldAbstract read
In one paragraph

Article in BMC pulmonary medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
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 8 institutions in 4 countries.

Daniel P SteinfortDepartment of Respiratory and Sleep Medicine, Royal Melbourne Hospital, 300 Grattan Street, VIC, Melbourne, 3050, Australia. Daniel.Steinfort@mh.org.au.ORCID http://orcid.org/0000-0002-8998-2949
Shankar SivaDepartment of Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Kanishka RangamuwaDepartment of Respiratory and Sleep Medicine, Royal Melbourne Hospital, 300 Grattan Street, VIC, Melbourne, 3050, Australia.
Percy LeeDepartment of Radiation Oncology, MD Anderson Cancer Center, The University of Texas, Houston, USA.
David FieldingDepartment of Thoracic Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
Phan NguyenDepartment of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia.
Barton R JenningsDepartment of Lung and Sleep, Monash Health, Melbourne, Australia.
Shaun YoDepartment of Lung and Sleep, Monash Health, Melbourne, Australia.
Nick HardcastleDepartment of Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Gargi KothariDepartment of Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Laurence CrombagDepartment of Pulmonology (VUmc), University of Amsterdam, Amsterdam, The Netherlands.
Jouke AnnemaDepartment of Pulmonology (AMC), University of Amsterdam, Amsterdam, The Netherlands.
Kazuhiro YasufukuDivision of Thoracic Surgery, Toronto General Hospital, Toronto, Canada.
David E OstDepartment of Pulmonary Medicine, MD Anderson Cancer Center, The University of Texas, Houston, USA.
Louis B IrvingDepartment of Respiratory and Sleep Medicine, Royal Melbourne Hospital, 300 Grattan Street, VIC, Melbourne, 3050, Australia.
Peter MacCallum Cancer Centre · AUThe Royal Melbourne Hospital · AUMonash Health · AUThe University of Texas MD Anderson Cancer Center · USUniversity of Amsterdam · NLRoyal Adelaide Hospital · AURoyal Brisbane and Women's Hospital · AUToronto General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is established as the preferred method of mediastinal lymph node (LN) staging in non-small cell lung cancer (NSCLC). Selective (targeted) LN sampling is most commonly performed however studies in early stage NSCLC and locally advanced NSCLC confirm systematic EBUS-TBNA evaluation improves accuracy of mediastinal staging. This study aims to establish the rate of detection of positron emission tomography (PET)-occult LN metastases following systematic LN staging by EBUS-TBNA, and to determine the utility of systematic mediastinal staging for accurate delineation of radiation treatment fields in patients with locally advanced NSCLC.

methodsConsecutive patients undergoing EBUS-TBNA for diagnosis/staging of locally advanced NSCLC will be enrolled in this international multi-centre single arm study. Systematic mediastinal LN evaluation will be performed, with all LN exceeding 6 mm to be sampled by TBNA. Where feasible, endoscopic ultrasound staging (EUS-B) may also be performed. Results of minimally invasive staging will be compared to FDG-PET. The primary end-point is proportion of patients in whom systematic LN staging identified PET-occult NSCLC metastases. Secondary outcome measures include (i) rate of nodal upstaging, (ii) false positive rate of PET for mediastinal LN assessment, (iii) analysis of clinicoradiologic risk factors for presence of PET-occult LN metastases, (iv) impact of systematic LN staging in patients with discrepant findings on PET and EBUS-TBNA on target coverage and dose to organs at risk (OAR) in patients undergoing radiotherapy. DISCUSSION: With specificity of PET of 90%, guidelines recommend tissue confirmation of positive mediastinal LN to ensure potentially early stage patients are not erroneously denied potentially curative resection. However, while confirmation of pathologic LN is routinely sought, the exact extent of mediastinal LN involvement in NSCLC in patient with Stage III NSCLC is rarely established. Studies examining systematic LN staging in early stage NSCLC report a significant discordance between PET and EBUS-TBNA. In patients with locally advanced disease this has significant implications for radiation field planning, with risk of geographic miss in the event of PET-occult mediastinal LN metastases. The SEISMIC study will examine both diagnostic outcomes following systematic LN staging with EBUS-TBNA, and impact on radiation treatment planning.

trial registrationACTRN12617000333314, ANZCTR, Registered on 3 March 2017.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsEndoscopic Ultrasound-Guided Fine Needle AspirationEndosonographyFluorodeoxyglucose F18HumansLymphatic MetastasisLymph NodesMediastinumMulticenter Studies as TopicNeoplasm StagingProspective StudiesFluorodeoxyglucose F18BronchoscopyCancer stagingCarcinomaEndoscopic ultrasonographyNon-small-cell lung

Identifiers

PMID36153502
PMCPMC9509615
OpenAlexW4296971447

What OpenQuestion holds

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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.