Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- GERD-HRQL
研究概览
简要总结
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
详细描述
Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.
After the ARMV procedure, PPI therapy is continued for 1 month to promote mucosal healing before being discontinued. If symptoms reoccur, the PPI management regimen is reinstated for the ARMV group, with diligent recording of PPI usage in a medication diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age;
- •Hiatal hernia ≤ 2 cm;
- •Sliding hernia ≤ 2 cm;
- •Recurrence of GERD symptoms after cessation of PPIs;
- •On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
- •Esophagitis (Los Angeles Classification) Grade B, C, or D;
- •Hill's flap valve grade ≤ III;
- •Observation of distal esophageal pH < 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
- •Normal or near-normal esophageal motility;
- •Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
- •DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
- •Completion of a signed informed consent form.
排除标准
- •BMI > 35 kg/m2;
- •ASA > II;
- •Barrett's esophagus;
- •Hiatal hernia > 2 cm;
- •Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
- •Hill's flap valve grade > III；
- •Peptic ulcer disease;
- •Primary esophageal motility disorders such as achalasia;
- •Severe gastroparesis;
- •History of previous esophageal or gastric surgery, including ARMS or ARMA;
- •Uncontrolled systemic diseases;
- •Gastric outlet obstruction;
- •Pregnancy or planning to become pregnant.
结局指标
主要结局
GERD-HRQL
时间窗: at 0, 6 months follow- up
Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores to questions 1-15 Greatest possible score (worst symptoms)= 75 Lowest possible score (no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
次要结局
- GERD-Q score(at 0, 3, 6 ,12 ,24,36 months follow- up)
- DeMeester score(at 0, 6 and 24 months follow- up)
- Presence of reflux esophagitis(at 0, 6 and 24 months follow- up)
- Appearance of the mucosal flap(at 6 and 24 months follow- up)
- PPI use(at 0, 3, 6 ,12 ,24,36 months follow- up)
- Incidence of adverse events(at 3, 6 ,12 ,24,36 months follow- up)
研究者
Lu Jiaoyang
professor
Qilu Hospital of Shandong University