内镜下多环套扎治疗难治性胃食管反流病合并食管裂孔疝的临床初探（含视频）

Preliminary clinical observations on endoscopic multi‑band ligation for refractory gastroesophageal reflux disease combined with esophageal hiatal hernia (with video)

摘要:

目的 探索内镜下多环套扎（endoscopic multi‑band ligation，EMBL）治疗难治性胃食管反流病（refractory gastroesophageal reflux disease，RGERD）合并食管裂孔疝（hiatal hernia，HH）的临床疗效及安全性。方法 本研究为前瞻性多中心小样本队列研究，选择2020年1月至2022年6月在内蒙古医科大学附属肿瘤医院确诊为RGERD合并HH的患者行EMBL，比较手术前后食管24 h pH监测和食管高分辨率测压（high resolution manometry，HRM）相关指标、胃食管反流指数（gastroesophageal reflux index，GERI）、胃食管反流病问卷调查量表（gastroesophageal reflux disease questionnaire，GERD‑Q）评分、胃食管反流病健康相关生活质量（gastroesophageal reflux disease health‑related quality of life，GERD‑HRQL）评分，调查患者的满意程度及并发症情况。结果 共纳入25例患者，均成功接受EMBL治疗，患者反流症状均有不同程度缓解，术中及术后均无穿孔、出血、吞咽困难等严重并发症出现。术后6个月及12个月随诊显示，DeMeester评分［18.00（5.83，54.75）分、16.30（4.38，60.00）分］较术前［105.00（60.80，147.70）分］相比显著下降（Z=-3.72，P<0.001；Z=-3.82，P<0.001），pH<4时间百分比［8.80（6.10，11.80）%、8.95（5.15，10.90）%］较术前［31.15（16.75，54.75）%］相比显著下降（Z=-3.72，P<0.001；Z=-3.72，P<0.001），长反流次数［7.90（4.93，11.75）次、6.90（4.00，10.75）次］较术前［33.00（13.00，43.00）次］相比显著下降（Z=-3.82，P<0.001；Z=-3.58，P<0.001），酸反流次数［（14.86±8.71）次、（12.93±5.51）次］较术前［（30.42±17.99）次］相比显著下降（t=5.88，P<0.001；t=4.79，P<0.001），食管下括约肌静息压［9.70（5.80，19.58）mmHg、11.70（5.40，19.78）mmHg］较术前［4.70（3.25，7.00）mmHg］相比显著升高（Z=-2.84，P<0.001；Z=-3.10，P<0.001），GERD‑Q评分［（10.00±2.01）分、（9.43±1.74）分］较术前［（15.34±1.51）分］相比显著下降（t=8.90，P<0.001；t=9.87，P<0.001），GERD‑HRQL评分［7.00（5.00，7.75）分、6.00（5.75，8.25）分］较术前［13.50（11.00，21.25）分］相比显著下降（Z=-3.73，P<0.001；Z=-3.72，P<0.001），GERI［（2.26±1.58）%、（2.07±1.17）%］较术前［（5.72±2.27）%］相比显著下降（t=8.92，P<0.001；t=9.86，P<0.001）。术后6、12个月随访，患者满意度［68.00%（15/25），84.00%（21/25）］较术前［0.00%（0/25）］明显增加（Z=-4.63，P<0.001；Z=-6.48，P<0.001）。结论 初步小样本研究表明，EMBL治疗难治性胃食管反流病合并食管裂孔疝疗效显著，安全可行。

Abstract:

Objective To explore the clinical efficacy and safety of endoscopic multi-band ligation (EMBL) in the management of refractory gastroesophageal reflux disease (RGERD) combined with esophageal hiatal hernia (HH). Methods This study was a prospective, multicenter, small-sample cohort study. Patients who were diagnosed as having RGERD combined with HH at Inner Mongolia Medical University Cancer Hospital and Inner Mongolia Medical University Hospital from January 2020 to June 2022 were selected to undergo EMBL. The 24-hour esophageal pH monitoring and high-resolution manometry (HRM) related indicators, gastroesophageal reflux index (GERI), gastroesophageal reflux disease questionnaire (GERD-Q) scores, and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores were compared before and after the operation. The patient satisfaction and complications were also investigated. Results A total of 25 patients were included, all of whom were successfully treated with EMBL. Reflux symptoms were relieved to varied degrees in all patients. There were no serious complications during or after the operation, such as perforation, bleeding, and dysphagia. Postoperative follow-up at 6 and 12 months showed a significant decrease in DeMeester scores [18.00 (5.83, 54.75) points, 16.30 (4.38, 60.00) points] compared to preoperative baseline [105.00 (60.80, 147.70) points, Z=-3.72, P<0.001; Z=-3.82, P<0.001]. The percentage of time of pH<4 [8.80 (6.10, 11.80)%, 8.95 (5.15, 10.90)%] significantly decreased compared to the baseline [31.15 (16.75, 54.75)%, Z=-3.72, P<0.001; Z=-3.72, P<0.001], the number of long refluxes [7.90 (4.93, 11.75) times, 6.90 (4.00, 10.75) times] significantly decreased compared to the baseline [33.00 (13.00, 43.00) times, Z=-3.82, P<0.001; Z=-3.58, P<0.001], and the number of acid refluxes (14.86±8.71 times, 12.93±5.51 times) significantly decreased compared to before (30.42±17.99 times, t=5.88, P<0.001; t=4.79, P<0.001). Lower esophageal sphincter resting pressure [9.70 (5.80, 19.58) mmHg, 11.70 (5.40, 19.78) mmHg] was significantly higher compared to before [4.70 (3.25, 7.00) mmHg, Z=-2.84, P<0.001; Z=-3.10, P<0.001]. GERD-Q scores (10.00±2.01 points, 9.43±1.74 points) were significantly higher compared to before (15.34±1.51 points, t=8.90, P<0.001; t=9.87, P<0.001), GERD-HRQL scores [7.00 (5.00, 7.75) points, 6.00 (5.75, 8.25) points] significantly decreased compared to preoperative baseline [13.50 (11.00, 21.25), Z=-3.73, P<0.001; Z=-3.72, P<0.001], and GERI (2.26%±1.58%, 2.07%±1.17%) significantly decreased compared to before (5.72%±2.27%, t=8.92, P<0.001; t=9.86, P<0.001). At 6 and 12 months postoperative follow-up, patient satisfaction [68.00% (15/25), 84.00% (21/25)] significantly increased compared to before [0.00% (0/25), Z=-4.63, P<0.001; Z=-6.48, P<0.001]. Conclusion Preliminary small-sample study has shown that EMBL is safe, reliable and effective for the treatment of RGERD with HH.