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Ultrasound guided fine needle aspiration cytology and sentinel node biopsy in the detection of occult lymph node metastases of early oral and oropharyngeal cancer.


- candidate number2767
- NTR NumberNTR1057
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2007
- Secondary IDs2007/190 (projectnumber VUmc) VUmc
- Public TitleUltrasound guided fine needle aspiration cytology and sentinel node biopsy in the detection of occult lymph node metastases of early oral and oropharyngeal cancer.
- Scientific TitleUltrasound guided fine needle aspiration cytology and sentinel node biopsy in the detection of occult lymph node metastases of early oral and oropharyngeal cancer.
- ACRONYMSNUS (Sentinel Node versus UltraSound)
- hypothesisApplication of sentinel node biopsy (in comparison to or combined with ultrasound guided fine needle aspiration cytology) improves the detection of occult lymph node metastases to a clinically relevant extent.
- Healt Condition(s) or Problem(s) studiedHead cancer, Neck cancer
- Inclusion criteria1. Patients with a primary biopsy proven oral/oropharyngeal squamous cell carcinoma;
2. Planned for transoral excision;
3. Without clinically suspected cervical lymph nodes.
- Exclusion criteria1. Transoral excision not possible;
2. Neck entered for reconstruction;
3. Clinical lymph node metastasis;
4. Age < 18 or > 80 year.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate1-jan-2010
- Target number of participants60
- InterventionsEach patient will ondergo ultrasound guided fine needle aspiration cytology (standard procedure) and sentinel node biopsy procedure.
- Primary outcomeDiagnostic accuracy of selection for treatment of the neck by strategies based on ultrasound guided fine needle aspiration cytology and/or sentinel node biopsy.
- Secondary outcomenumber of neck dissections, quality of life, patient's perspective, cost-effectiveness of selection strategies based on ultrasound fine needle aspiration cytology and/or sentinel node biopsy or elective treatment of the neck.
- Timepoints
- Trial web sitenot applicable
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. R. Bree, de
- CONTACT for SCIENTIFIC QUERIESdrs G.B. Flach
- Sponsor/Initiator VU University Medical Centre, department of Otolaryngology / Head and Neck Surgery
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsnot applicable
- Brief summaryEvaluation and comparison of sentinel node biopsy and ultrasound guided fine needle aspiration cytology in the management of the clinically negative neck in patients planned for transoral excision of oral and oropharyngeal squamous cell carcinoma.
- Main changes (audit trail)
- RECORD24-sep-2007 - 26-nov-2010


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