Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, via Olgettina 58, 20132, Milano, Italy.
Division of Gastrointestinal Endoscopy, Treviglio-Caravaggio Hospital, ASST Bergamo Ovest, Treviglio, Italy.
Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.
Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE.
Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis).
TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year.
TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases.
GOV: ID: NCT03669874.
经口无切口胃底折叠术（TIF）联合 Medigus 超声外科吻合器（MUSE）是一种治疗胃食管反流病（GERD）的新方法。我们旨在评估 MUSE 行 TIF 的临床、功能和内镜效果。
46 例患者接受了 TIF。质子泵抑制剂（PPI）的使用、GERD 健康相关生活质量（HRQL）和反流症状指数（RSI）问卷、上消化道（GI）内镜检查、食管 24 小时 pH 阻抗监测和高分辨率测压（HRM）在 TIF 前和 6 个月和 12 个月后（仅在 6 个月时进行 HRM）进行。然后每年评估 PPI 的使用和症状。本研究报告了 3 年的数据（PP 和 ITT 分析）。
46 例患者中，45 例成功进行了 TIF；1 例患者食管插管困难。两例发生穿孔。1 例患者在 6 个月内需要手术。42 例患者在 6 个月和 1 年时可进行临床随访，35 例患者在 2 年时，31 例患者在 3 年时可进行临床随访。在 1、2 和 3 年时，分别有 64.3%、62.9%和 74.2%的患者（ITT 分析：58.7%、56.4%和 65.7%）停止使用 PPI。GERD-HRQL 和 RSI 评分分别至少下降 50%，分别为 71.5%和 76.2%、71.4%和 68.6%和 67.7%（ITT 分析：65.2%和 69.6%、64.1%和 61.5%和 60%）。在 3 年内观察到这两个评分都有显著改善。31 例和 20 例患者可进行 6 个月和 1 年的功能随访。HRM 显示中位食管下括约肌长度和蠕动波率显著增加。食管 pH 阻抗监测发现，在 6 个月时，酸、近端和总反流以及食管 pH<4 总时间百分比显著减少，但在 1 年时没有减少。
MUSE 行 TIF 可显著改善症状和 PPI 使用率，最长可达 3 年。然而，在 1 年内仍有三分之一的患者存在食管炎，6 个月时的功能改善在 1 年内并未得到证实。两例患者发生严重并发症，需要手术治疗。
政府：ID：NCT03669874。
