Surgeon-performed Intraoperative Transoral Ultrasound in Patients With Suspected Head and Neck Squamous Cell Carcinoma of Unknown Primary: a Prospective Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Increased detection rate by adding ITUS to panendoscopy
研究概览
简要总结
Adult patients suspected of Squamous Cell Carcinoma of Unknown Primary (SCCUP) will be prospectively enrolled at a tertiary head & neck cancer center at Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. All patients will undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) prior to examination in general anesthesia. During general anesthesia, Intraoperative Transoral Ultrasound (ITUS) will be performed prior to panendoscopy. Detected tumors will be registered with specified oropharyngeal sub-locations. Blinded to ITUS, a consultant head & neck surgeon will perform panendoscopy. After examination, the surgeon is unblinded to ultrasound results. Final histopathology results from location-specified biopsies performed will be used as reference standard. The overall detection rate will be compared between ITUS, panendoscopy, PET-CT and MRI with sensitivity and specificity analysis. Oropharynx sub-location specific detection rate of ITUS vs. panendoscopy will be compared with logistic regression analysis.
详细描述
A prospective diagnostic study examining patients with suspected SCCUP will be performed at the Department of Otorhinolaryngology & Head & Neck Surgery, Copenhagen University Hospital - Rigshospitalet, Denmark. This specialized cancer center is responsible for the surgical work-up for approximately half of suspected SCCUP patients in the Danish population of 5.8 million.
Standard work-up of patients with suspected SCCUP in Denmark consists of same-day clinical examination combined with high resolution video endoscopy with NBI, surgeon-performed neck ultrasound and fine-needle aspiration cytology (FNAC) of suspected lymph nodes with same-day results. Cytology results can be further tested for Human Papillomavirus (HPV), and patients are booked for panendoscopic examination under general anesthesia with frozen section biopsy. Pre-operative cross-sectional imaging to locate the primary tumor includes MRI and 18-F Fluordeoxyglucose (FDG) PET-CT.
Intraoperative transoral ultrasound
During general anesthesia and prior to panendoscopy, ITUS will be performed while a consultant head & neck surgeon performing panendoscopy is blinded. A Fujifilm Arietta 850 or Arietta 65 (Fujifilm, Tokyo, Japan), BK5000 (BK Medical ApS, Herlev, Denmark), or Samsung RS85 (Samsung Medison, Seoul, South Korea) ultrasound machines will be used. Small-footprint, high-frequency transducers such as the Arietta L51K linear-array intraoperative robot transducer attached to a forceps, the BK5000 "flexible hockey-stick" 18XL5s, or the Samsung RS85 LA3-22AI "hockeystick" will be used. A Boyle-Davis gag or laryngoscope will be used to visualize the tonsils (Figure 1), while the transducer is placed onto each tonsil in transverse and sagittal planes. The tongue base will be scanned by pulling the tongue anteriorly by an assistant and placing the transducer directly onto the tongue base. Alternatively, the tongue can be retracted with a video-laryngoscope while revealing the tongue base. The tongue base will be scanned from side to side in the sagittal plane. The tongue can then be pulled to either the left or right side to angle the probe obliquely for transverse imaging. If a tumor is suspected, the tumor location is registered in the following categories, including indication of right or left side:
- Tonsil cranial.
- Tonsil caudal.
- Glossotonsillar sulcus.
- Anterolateral tongue base.
- Anteromedial tongue base.
- Posterolateral tongue base.
- Posteromedial tongue base.
- "Other" oropharynx sub-locations, including anterior & posterior pharyngeal arches, soft palate, uvula, posterior oropharynx wall, and vallecula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytology-verified cervical lymph node metastasis from squamous cell carcinoma in neck levels I-IV with HPV+ cytology.
- •Booked for panendoscopic examination under general anesthesia.
- •Pre-operative MRI and PET-CT available.
排除标准
- •Unable to provide written informed consent.
- •Unable to complete full surgical work-up including palatine- and lingual tonsillectomy.
结局指标
主要结局
Increased detection rate by adding ITUS to panendoscopy
时间窗: Within 2-4 weeks after panendoscopy.
The difference in proportion of patients with SCCUP where a primary tumor location is correctly detected by ITUS but not detected with panendoscopy alone.
次要结局
- Comparison of detection rate of ITUS, panendoscopy, combined ITUS+panendoscopy, MRI and PET-CT for locating the primary tumor.(1 year)
- Ultrasonographic features of primary tonsil and tongue base tumors(1 year)
研究者
Martin Garset-Zamani, MD
Principal Investigator
Rigshospitalet, Denmark