ArticleTrials2019
The necessity of IIb dissection in T1-T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
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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.
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.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.
- Interventions for the treatment of oral cavity and oropharyngeal cancers: surgical treatment.The Cochrane database of systematic reviews · 2023Pooled it
- Sentinel node biopsy versus elective neck dissection in early-stage oral cancer: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2020Pooled it
- [Effects of structured rehabilitation training on shoulder syndrome after cervical lymph neck dissection in patients with oral cancer].Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026Trial
- Superior spinal accessory nerve function after robotic versus open selective neck dissection in papillary thyroid carcinoma: a retrospective and prospective cohort study.Journal of robotic surgery · 2026Article
- Comprehensive survival analysis of oral squamous cell carcinoma patients undergoing initial radical surgery.BMC oral health · 2024Article
- Potential of melatonin to reverse epigenetic aberrations in oral cancer: new findings.EXCLI journal · 2023Review
- Letter to the Editor: Relevance of Level IIb Neck Dissection in Patients with Head and Neck Squamous Cell Carcinomas.World journal of surgery · 2020Article
- Authors' Reply: Relevance of Level IIb Neck Dissection in Patients with Head and Neck Squamous Cell Carcinomas.World journal of surgery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend the latter while improving the former. Following neck dissection of early-stage oral carcinoma, "shoulder syndrome" appears due to traction of the accessory nerve during removal of level IIb, which greatly affects patient quality of life. Since occult metastasis in level IIb of early-stage oral carcinoma is extremely low, some surgeons suggest that level IIb can be exempt from dissection to improve the HRQoL. However, other surgeons take the opposite view, and thus there is no consensus on the necessity of IIb dissection in T1-2N0M0 oral squamous cell carcinoma (OSCC).
methodsWe designed a parallel-group, randomized, non-inferiority trial that is supported by Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China. We will enroll 522 patients with early oral carcinoma who match the inclusion criteria, and compare differences in 3-year overall survival, progression-free survival (PFS) and HRQoL under different interventions (retention or dissection of level IIb). The primary endpoints will be tested by means of two-sided log-rank tests. Analysis of overall and progression-free survival will be performed in subgroups that were defined according to stratification factors with the use of univariate Cox analysis. In addition, we will use post-hoc subgroup analyses on the basis of histological factors that were known to have effects on survival, such as death of invasion of the primary tumor. To evaluate HRQoL, we will choose the Constant-Murley scale to measure shoulder function. DISCUSSION: Currently, there are no randomized controlled trials with large sample sizes on the necessity of IIB dissection in T1-T2N0M0 OSCC. We designed this noninferiority RCT that combines survival rate and HRQoL to assess the feasibility of IIb neck dissection. The result of this trial may guide clinical practice and change the criteria of how early-stage oral cancer is managed. The balance between survival and HRQoL in this trial is based on early-stage breast cancer treatment and may provide new ideas for other malignancies.
trial registrationChinese Clinical Trial Registry, ChiCTR1800019128 . Registered on 26 October 2018.
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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.