Evidence map›Paper›PMID 30717811›Full record

ArticleTrials2019

Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial.

Ingo Stoffels, Ken Herrmann, Jan Rekowski, Philipp Jansen, Dirk Schadendorf, Andreas Stang, Joachim Klode

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03683550 (Randomized Trial Comparing Sentinel Lymph Node Excision), which is not on this 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 26% 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.

NCT03683550 naunknown statusnot on this map

Randomized Trial Comparing Sentinel Lymph Node Excision (SLNE) With or Without Preoperative Hybrid Single-photon Emission Computed Tomography/Computed Tomography (SPECT/CT) in Melanoma

TypeinterventionalSponsorUniversity Hospital, EssenRan2018 to 2025Enrolled836ConditionsMelanomaArmsSLNE with preoperative hybrid SPECT/CT, Standard SLNE
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. The Role and Potential ofDiagnostics (Basel, Switzerland) · 2022
    Review
  4. Nanomaterial Probes for Nuclear Imaging.Nanomaterials (Basel, Switzerland) · 2022
    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

7 authors at 3 institutions in 1 country.

Ingo StoffelsDepartment of Dermatology, Venerology and Allergology, University-Hospital Essen, University of Duisburg-Essen, 45122, Essen, Germany.
Ken HerrmannCenter of Clinical Epidemiology, Institute of Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, 45122, Essen, Germany.
Jan RekowskiDepartment of Nuclear Medicine, University of Essen-Duisburg, 45122, Essen, Germany.
Philipp JansenDepartment of Dermatology, Venerology and Allergology, University-Hospital Essen, University of Duisburg-Essen, 45122, Essen, Germany.
Dirk SchadendorfDepartment of Dermatology, Venerology and Allergology, University-Hospital Essen, University of Duisburg-Essen, 45122, Essen, Germany.
Andreas StangDepartment of Nuclear Medicine, University of Essen-Duisburg, 45122, Essen, Germany.
Joachim KlodeDepartment of Dermatology, Venerology and Allergology, University-Hospital Essen, University of Duisburg-Essen, 45122, Essen, Germany. joachim.klode@uk-essen.de.
University of Duisburg-Essen · DEEssen University Hospital · DEInstitut für Medizinische Informatik, Biometrie und Epidemiologie · DE

Funding

Deutsche Forschungsgemeinschaft KL 2918/2-1
6 · The paper itself

Abstract

backgroundMelanoma has become a growing interdisciplinary problem in public health worldwide. According to the World Health Organization, the incidence of melanoma is increasing faster than any other cancer in the world. Because melanoma metastasizes early into the regional lymph nodes, sentinel lymph node excision (SLNE) is included in the current American Joint Committee of Cancer guidelines. However SLNE of melanoma has a high false-negative rate of up to 44%.

methodsThe gold standard for detection and extirpation of the sentinel lymph node is preoperative lymphoscintigraphy. SPECT/CT provides complementary information: the advantages include accurate anatomical localization, identification of false positives, reduction in the number of false negatives, and alteration of the surgical approach. Therefore, sentinel lymph node-SPECT/CT provides valuable information before sentinel lymph node excision and advocates its use in melanoma. We present a multicenter, unblinded superiority randomized controlled trial to compare SPECT/CT-aided SLNE versus standard SLNE in melanoma patients. DISCUSSION: The primary efficacy endpoint is distant metastasis-free survival. Secondary endpoints comprise overall survival, disease-free survival, rate of local relapses within the follow-up period (false-negative rate of sentinel lymph node), number of positive sentinel lymph nodes (sensitivity, false-positive rate), complication rate, quality of life, quality-adjusted life years, inpatient days, and overall costs during hospital stays.

trial registrationClinicalTrials.gov, NCT03683550 . Registered on 20 September 2018.

Indexed as

Sentinel Lymph Node BiopsySingle Photon Emission Computed Tomography Computed TomographyAdolescentAdultAgedEquivalence Trials as TopicFalse Negative ReactionsFalse Positive ReactionsFemaleGermanyHumansLymphatic MetastasisLymph NodesLymphoscintigraphyMaleMelanomaMalignant melanomaSentinel lymph node excisionSPECT/CT

Identifiers

PMID30717811
PMCPMC6360709
OpenAlexW2913383353

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.