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.
Adolescent
Adult
Aged
Equivalence Trials as Topic
False Negative Reactions
False Positive Reactions
Female
Germany
Humans
Lymph Nodes
/ diagnostic imaging
Lymphatic Metastasis
Lymphoscintigraphy
/ methods
Male
Melanoma
/ diagnostic imaging
Middle Aged
Multicenter Studies as Topic
Predictive Value of Tests
Reproducibility of Results
Sentinel Lymph Node Biopsy
Single Photon Emission Computed Tomography Computed Tomography
Skin Neoplasms
/ diagnostic imaging
Young Adult
Malignant melanoma
SPECT/CT
Sentinel lymph node excision
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 Feb 2019
04 Feb 2019
Historique:
received:
05
10
2018
accepted:
14
01
2019
entrez:
6
2
2019
pubmed:
6
2
2019
medline:
14
6
2019
Statut:
epublish
Résumé
Melanoma 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%. The 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. 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. ClinicalTrials.gov, NCT03683550 . Registered on 20 September 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Melanoma 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%.
METHODS
METHODS
The 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
CONCLUSIONS
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 REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03683550 . Registered on 20 September 2018.
Identifiants
pubmed: 30717811
doi: 10.1186/s13063-019-3197-7
pii: 10.1186/s13063-019-3197-7
pmc: PMC6360709
doi:
Banques de données
ClinicalTrials.gov
['NCT03683550']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
99Subventions
Organisme : Deutsche Forschungsgemeinschaft
ID : KL 2918/2-1
Organisme : Deutsche Forschungsgemeinschaft
ID : KL 2918/2-1
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