Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: Anobservational Single-institutional Study From 1998
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the difference in proportions of non necrotic complications in the two groups of patients.
研究概览
简要总结
The aim of this study will be to assess the association between the type of a surgical flap and post-operative complication in patients with hypopharyngeal cancer undergoing salvage surgery (SS) and reconstruction with free or pedicled flaps.
详细描述
Squamous cell carcinoma of the hypopharynx (HPSCC) is a rare but aggressive cancer, accounting for only 3-5% of all head and neck cancers. It occurs in the III-IV stage in about 60-85 % of cases, with 5-year overall survival (OS) ranging from 25 to 41%. It tends to spread in local submucosa, with an early involvement of the larynx and the locoregional tissue. Disease recurrence is around 15% to 40%, depending on the casuistry, the type of primary treatment (surgery vs. organ preservation protocols) and personal experience of each center. In recurrence setting, where indicated, salvage surgery (SS) remains the gold standard with the highest survival rates compared to conservative therapy. Generally patients are frail, with poor performance status and countless comorbidities and between 33% to 66% of cases are eligible to surgery with curative intent. In fact, in salvage setting the risk of peri-operative mortality is higher, postoperative complications are more frequent and hospital stay is longer.
Therefore, a careful selection of candidates is imperative and based on the following criteria: age and comorbidities, site of recurrence, stage, time interval since the first treatment and type of previous therapies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrence of hypopharynx/hypopharyngolarynx cancer after the first hypopharynx/hypopharyngolarynx tumor;
- •treatment with salvage surgery and reconstruction using free or pedicled flaps.
排除标准
- •recurrence of cancer in a location other than the hypopharynx/hypopharyngolarynx or with the first tumor in a location other than the hypopharynx/hypopharyngolarynx;
- •treatment with salvage surgery without flap reconstruction or with salvage treatment not involving flap reconstruction
结局指标
主要结局
the difference in proportions of non necrotic complications in the two groups of patients.
时间窗: up to 24 months
次要结局
- the difference in proportions of necrotic complications in the two groups of patients.(up to 24 months)
研究者
Simone Mauramati
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
