Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Voice Outcome
研究概览
简要总结
Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer.
Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
- •Lesion amenable to CO2 TLM resection.
排除标准
- •Previous radiotherapy to the head and neck.
- •Palpable, or radiographic, pathological lymphadenopathy.
- •Allergy, or sensitivity, to HA or components of the injectable.
- •Neurological disorder affecting phonation, such as multiple sclerosis or stroke.
研究组 & 干预措施
Treatment Group - Receiving Hyaluronic Acid Injection
Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
干预措施: Hyaluronic acid (Drug)
Control Group - Not Receiving Hyaluronic Acid Injection
Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
干预措施: No Hyaluronic Acid Injection Injection (Other)
结局指标
主要结局
Voice Outcome
时间窗: Changes at 24 months post-operatively compared to baseline.
Maximum Phonation Time
次要结局
- Recurrence-free survival(24 months post-augmentation)
- Overall survival(24 months post-augmentation)
- Disease free survival(24 months post-augmentation)
研究者
Ayhman Al Afif
Principal Investigator
Nova Scotia Health Authority