Background/Objectives: Colonoscopies have some limitations that result in a miss rate detection of polyps. Microwave imaging has been demonstrated to detect colorectal polyps based on their dielectric properties in synthetic phantoms, ex vivo tissues and in vivo animal models. This study aims to evaluate, for the first time, the feasibility, safety and performance of microwave-based colonoscopy for diagnosis of polyps in real-time explorations in humans.Methods: This was a single-center, prospective, observational study. Patients referred for diagnostic colonoscopy were explored with a device with microwave antennas which was attached to the tip of a standard colonoscope. The primary outcomes were rate of cecal intubation, adverse events, mural injuries and performance metrics for the detection of polyps. Secondary outcomes were the following: patients’ subjective feedback, procedural time and perception of difficulty according to the endoscopist.Results: Fifteen patients were enrolled. Cecal intubation rate was 100%, with a mean time of 12.7 ± 4.9 min (range 4–22). Use of the device did not affect the endoscopic image, and polypectomy was successfully performed in all cases. In on scale from zero (not difficult) to four (very difficult), the maneuverability during the insertion was considered ≤2 in the 86.7% (13/15) of colonoscopies. Only 16 incidents were reported in 14 patients: 11 (67%) superficial hematomas, 2 minor rectal bleedings, 1 anal fissure, 1 rhinorrhea and 1 headache. Most of the patients (94%) reported no discomfort or minimal discomfort before discharge (Gloucester score 1 and 2, respectively). In the six patients with 23 polyps used for the performance analysis, the sensitivity and specificity were 86.9% and 72.0%, respectively.Conclusions: microwave-based colonoscopy is safe and feasible and has the potential to detect polyps in real colonoscopies.
背景/目的：结肠镜检查存在一定局限性，导致息肉漏检率较高。微波成像技术已通过仿真模型、离体组织及活体动物实验证实，能够基于结直肠息肉的介电特性实现检测。本研究首次旨在评估微波辅助结肠镜在人体实时探查中诊断息肉的可行性、安全性及检测效能。 方法：本研究为单中心前瞻性观察性研究。对转诊接受诊断性结肠镜检查的患者，在标准结肠镜前端加装微波天线装置进行探查。主要结局指标包括盲肠插管成功率、不良事件发生率、肠壁损伤情况及息肉检测效能指标。次要结局指标包括：患者主观反馈、操作时间及内镜医师感知的操作难度。 结果：共纳入15例患者。盲肠插管成功率达100%，平均操作时间为12.7±4.9分钟（范围4-22分钟）。设备使用未影响内镜成像质量，所有病例均成功完成息肉切除术。在0分（无难度）至4分（极困难）的操作难度评分中，86.7%（13/15）的结肠镜检查在进镜阶段操作难度评分≤2分。14例患者共报告16例次不良事件：11例（67%）为浅表血肿，2例轻微直肠出血，1例肛裂，1例鼻漏及1例头痛。绝大多数患者（94%）在出院前报告无不适或轻微不适（格洛斯特评分分别为1分和2分）。在6例携带23枚息肉的检测效能分析中，敏感性和特异性分别为86.9%和72.0%。 结论：微波辅助结肠镜检查安全可行，在真实结肠镜检查中具有息肉检测潜力。
New Concept of Colonoscopy Assisted by a Microwave-Based Accessory Device: First Clinical Experience
肿瘤(癌症)患者之家