多中心研究中，经牵引胶囊内镜检查 Barrett 食管的可行性和安全性。
Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study.
机构信息
Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts.
出版信息
Clin Gastroenterol Hepatol. 2022 Apr;20(4):756-765.e3. doi: 10.1016/j.cgh.2021.02.008. Epub 2021 Feb 4.
BACKGROUND & AIMS: Tethered capsule endomicroscopy (TCE) involves swallowing a small tethered pill that implements optical coherence tomography (OCT) imaging, procuring high resolution images of the whole esophagus. Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi-center (5-site) clinical study.
METHODS
Untreated patients with BE as per endoscopic biopsy diagnosis were eligible to participate in the study. TCE procedures were performed in unsedated patients by either doctors or nurses. After the capsule was swallowed, the device continuously obtained 10-μm-resolution cross-sectional images as it traversed the esophagus. Following imaging, the device was withdrawn through mouth, and disinfected for subsequent reuse. BE lengths were compared to endoscopy findings when available. OCT-TCE images were compared to volumetric laser endomicroscopy (VLE) images from a patient who had undergone VLE on the same day as TCE.
RESULTS
147 patients with BE were enrolled across all sites. 116 swallowed the capsule (79%), 95/114 (83.3%) men and 21/33 (63.6%) women (P = .01). High-quality OCT images were obtained in 104/111 swallowers (93.7%) who completed the procedure. The average imaging duration was 5.55 ± 1.92 minutes. The mean length of esophagus imaged per patient was 21.69 ± 5.90 cm. A blinded comparison of maximum extent of BE measured by OCT-TCE and EGD showed a strong correlation (r = 0.77-0.79). OCT-TCE images were of similar quality to those obtained by OCT-VLE.
CONCLUSIONS
The capabilities of TCE to be used across multiple sites, be administered to unsedated patients by either physicians or nurses who are not expert in OCT-TCE, and to rapidly and safely evaluate the microscopic structure of the esophagus make it an emerging tool for screening and surveillance of BE patients. Clinical trial registry website and trial number: NCT02994693 and NCT03459339.
背景与目的
tethered 胶囊内镜（TCE）涉及吞咽一个小的 tethered 药丸，该药丸实施光学相干断层扫描（OCT）成像，获取整个食管的高分辨率图像。在这里，我们在多中心（5 个地点）临床研究中证明并评估 TCE 和便携式 OCT 成像系统在 Barrett 食管（BE）患者中的可行性和安全性。
方法
根据内镜活检诊断，未经治疗的 BE 患者有资格参加研究。TCE 程序由医生或护士在未镇静的患者中进行。胶囊吞下后，设备在穿过食管时连续获得 10-μm 分辨率的横截面图像。成像后，设备通过口腔撤回，并进行消毒以随后重复使用。BE 长度与可用的内镜检查结果进行比较。将 OCT-TCE 图像与同一天接受 VLE 的患者的容积激光内窥镜检查（VLE）图像进行比较。
结果
所有地点共纳入 147 例 BE 患者。116 例患者吞下胶囊（79%），95/114（83.3%）名男性和 21/33（63.6%）名女性（P =.01）。完成该程序的 111 名吞咽者中的 104 名（93.7%）获得了高质量的 OCT 图像。平均成像持续时间为 5.55±1.92 分钟。每位患者成像的食管平均长度为 21.69±5.90cm。OCT-TCE 测量的最大 BE 范围与 EGD 相比具有很强的相关性（r = 0.77-0.79）。OCT-TCE 图像的质量与 OCT-VLE 获得的图像相似。
结论
TCE 具有在多个地点使用、由非专家 OCT-TCE 医生或护士对未镇静患者进行管理、以及快速安全地评估食管微观结构的能力，使其成为筛查和监测 BE 患者的新兴工具。临床试验注册网站和试验编号：NCT02994693 和 NCT03459339。
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