Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.
PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.
研究概览
地位
条件
详细说明
OBJECTIVES:
Primary
- Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.
Secondary
- Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.
OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.
Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.
Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.
After completion of study procedure, patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
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Michigan
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Detroit、Michigan、美国、48201-1379
- Barbara Ann Karmanos Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes
Malignant disease must meet the following criteria:
Histologically confirmed diagnosis of 1 of the following:
- Glottic cancer (T1, T2, and T3)
- Supraglottic cancer (T1, T2, and T3)
- Hypopharyngeal cancer (T1 and T2)
- Oropharyngeal cancer (T1, T2, and T3)
- Nasopharyngeal cancer (T1 and T2)
- Resectable involved lymph nodes
No invasion of osseous and/or osseocartilaginous structures including the following:
- Mandibular bone
- Thyroid cartilage
- Hyoid bone
- Cricoid bone
- Vertebral body
- No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base
- No radiological confirmation of carotid artery involvement
- No fixation of tumor to the prevertebral fascia
- No bilateral arytenoid involvement
- No surgical defect requiring open approach for reconstruction
- No evidence of distant metastasis
PATIENT CHARACTERISTICS:
- Not pregnant
- No unexplained fever and/or untreated active infection
- No medical conditions contraindicating general anesthesia
- No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Operative time that directly affects operative cost
大体时间:post operative
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post operative
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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失血
大体时间:手术期间
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手术期间
|
|
Intra-operative and post-operative complications
大体时间:during the operation and post operative
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during the operation and post operative
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Need for reconstruction
大体时间:post operative
|
post operative
|
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Margins status
大体时间:post operative
|
post operative
|
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Length of hospital stay
大体时间:during time as inpatient
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during time as inpatient
|
|
Tracheostomy and PEG dependence
大体时间:post operative
|
post operative
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Days to oral intake
大体时间:post operative
|
post operative
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Time to locoregional recurrence
大体时间:post operative
|
post operative
|
|
Speech intelligibility
大体时间:post operative
|
post operative
|
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Quality of life
大体时间:3 months and 6 month following completion of surgery
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3 months and 6 month following completion of surgery
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Postoperative pain
大体时间:post operative
|
post operative
|
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Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
大体时间:post operative
|
post operative
|
合作者和调查者
调查人员
- 首席研究员:Ho-Sheng Lin, MD、Barbara Ann Karmanos Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CDR0000642940
- P30CA022453 (美国 NIH 拨款/合同)
- WSU-2008-022
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