Lacy Brian E, O'Shana Tracia, Hynes Mary, Kelley Maurice L, Weiss Julia E, Paquette Lisa, Rothstein Richard I
Section of Gastroenterology & Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA.
Am J Gastroenterol. 2007 Jan;102(1):24-32. doi: 10.1111/j.1572-0241.2006.00889.x. Epub 2006 Nov 13.
To prospectively calculate and validate a conversion factor in healthy volunteers that allows accurate nonsedated, transoral (TO) Bravo capsule placement after transnasal (TN) manometry, and to evaluate the ease and safety of nonendoscopic Bravo placement compared with endoscopic placement.
Part 1. Twenty-five healthy volunteers underwent sequential TN and TO esophageal manometry to measure the distance to the lower esophageal sphincter (LES). A TN to TO conversion factor was calculated from these measurements. Part 2. Twenty volunteers underwent TN manometry followed by unsedated TO Bravo capsule placement using the conversion factor calculated in part 1. TN endoscopy then measured the location of the Bravo capsule in relationship to the squamocolumnar junction (SCJ). Part 3. During an 18-month period, 370 consecutive patients referred for a Bravo procedure underwent nonendoscopic, unsedated TO placement (308 patients) or standard endoscopically assisted placement (62 patients).
Part 1. All 25 volunteers completed TN and TO manometry; a conversion factor of 4 cm was calculated. Part 2. Using the calculated conversion factor of 4 cm, a Bravo capsule was deployed TO 5 cm above the proximal border of the LES. The mean +/- standard deviation (SD) TN endoscopic distance to the capsule was 6.0 cm (+/-0.3 cm) above the SCJ. Part 3. A total of 333 patients completed the entire study (90%). Analysis of 48-h pH measurements did not reveal any significant differences between the two groups.
A reliable and valid conversion factor of 4 cm following TN manometry permits accurate TO placement of the Bravo capsule without endoscopy. TO, unsedated Bravo placement is safe, well tolerated, and may minimize costs and potential risks associated with endoscopy.
前瞻性计算并验证健康志愿者的一个转换系数，该系数能使经鼻（TN）测压后准确无误地进行非镇静经口（TO）Bravo胶囊放置，并评估与内镜放置相比，非内镜下Bravo放置的简易性和安全性。
第一部分。25名健康志愿者先后接受TN和TO食管测压，以测量至食管下括约肌（LES）的距离。根据这些测量结果计算出TN至TO的转换系数。第二部分。20名志愿者接受TN测压，然后使用第一部分计算出的转换系数进行非镇静TO Bravo胶囊放置。随后通过TN内镜检查测量Bravo胶囊相对于鳞柱状上皮交界处（SCJ）的位置。第三部分。在18个月期间，370名连续接受Bravo手术的患者接受了非内镜下非镇静TO放置（308例患者）或标准内镜辅助放置（62例患者）。
第一部分。所有25名志愿者均完成了TN和TO测压；计算出的转换系数为4厘米。第二部分。使用计算出的4厘米转换系数，将Bravo胶囊放置在LES近端边界上方5厘米处。胶囊至TN内镜检查的平均±标准差（SD）距离为SCJ上方6.0厘米（±0.3厘米）。第三部分。共有333名患者完成了整个研究（90%）。对48小时pH值测量的分析未发现两组之间有任何显著差异。
TN测压后4厘米的可靠且有效的转换系数可使Bravo胶囊在无需内镜检查的情况下准确进行TO放置。非镇静TO Bravo放置安全、耐受性良好，并且可以将与内镜检查相关的成本和潜在风险降至最低。
