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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Michigan
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Operative time that directly affects operative cost
時間枠：post operative
|
post operative
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
失血
時間枠：手術中
|
手術中
|
|
Intra-operative and post-operative complications
時間枠：during the operation and post operative
|
during the operation and post operative
|
|
Need for reconstruction
時間枠：post operative
|
post operative
|
|
Margins status
時間枠：post operative
|
post operative
|
|
Length of hospital stay
時間枠：during time as inpatient
|
during time as inpatient
|
|
Tracheostomy and PEG dependence
時間枠：post operative
|
post operative
|
|
Days to oral intake
時間枠：post operative
|
post operative
|
|
Time to locoregional recurrence
時間枠：post operative
|
post operative
|
|
Speech intelligibility
時間枠：post operative
|
post operative
|
|
Quality of life
時間枠：3 months and 6 month following completion of surgery
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3 months and 6 month following completion of surgery
|
|
Postoperative pain
時間枠：post operative
|
post operative
|
|
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
時間枠：post operative
|
post operative
|
協力者と研究者
捜査官
- 主任研究者：Ho-Sheng Lin, MD、Barbara Ann Karmanos Cancer Institute
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CDR0000642940
- P30CA022453 (米国 NIH グラント/契約)
- WSU-2008-022
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