A Randomized Controlled Trial Comparing Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 636
- 主要终点
- Incidence of Gastro esophageal Reflux disease (GERD) after poem
研究概览
简要总结
Rationale for This Study The primary rationale for this study is to evaluate whether a shorter submucosal tunnel during POEM with an EGJ-focused myotomy in type II Achalasia cardia patients, provides equivalent or superior symptom relief compared to the conventional approach while minimizing adverse events such as GERD & blown out myotomy and decreasing the procedure time.
Objectives
Primary Objective:
To compare the incidence of GERD (with manual review) at 3 and 12 months' post-procedure between conventional POEM and two experimental short-tunnel POEM techniques in patients with Type II achalasia.
Secondary Objectives:
To evaluate
- Clinical success based on Eckardt score
- Operating total procedure time
- Use of Acid Suppressants on Follow up at 1 year
- Severity of Esophagitis at 3 months
- Intraoperative & Postoperative adverse events (AGREE classification),
- GERD-HRQL (0-18) scores 3 & 12 Months
- (Clinically relevant GORD was defined as excessive oesophageal /AET associated with a GERDQ score >7 and/or with any grade of reflux oesophagitis).
- Duration of Hospital stay
- Quality of life (SF36)
详细描述
Achalasia type II is the most common manometric subtype and responds well to Peroral Endoscopic Myotomy (POEM). However, the optimal extent of submucosal tunneling and myotomy length for this population remains uncertain. Conventional POEM typically involves a 10-12 cm submucosal tunnel with a long esophageal myotomy (6-8 cm) and a 2-3 cm gastric extension. While effective, this approach may predispose patients to higher rates of post-procedure gastroesophageal reflux disease (GERD), mucosal injuries, and CO₂-related insufflation events due to more extensive dissection.
Recent physiologic data from FLIP studies suggest that disrupting the esophagogastric junction (EGJ) complex alone-approximately 2 cm proximally and 2-3 cm distally-may be sufficient to normalize EGJ distensibility in achalasia. Additional proximal myotomy does not appear to improve compliance and may unnecessarily increase the risk of adverse events or compromise esophageal motor recovery. Emerging randomized studies have further shown that shorter esophageal myotomies (≤5 cm) can provide symptom relief comparable to standard approaches, with potentially lower reflux rates.
This trial evaluates whether limiting myotomy to the EGJ complex, with or without a shorter submucosal tunnel, can reduce post-POEM GERD while maintaining clinical efficacy in Type II achalasia. The study uses a three-arm randomized controlled design comparing:
Conventional POEM with long submucosal tunnel and long esophageal myotomy;
Standard-length tunnel with EGJ-only myotomy, preserving proximal esophageal muscle while maintaining full tunnel access;
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >18 years.
- •Diagnosis of Type II achalasia naïve patients based on high-resolution manometry (Chicago Classification v4).
- •Eckardt score >
- •Written informed consent
排除标准
- •Type I or III achalasia.
- •Previous endoscopic or surgical treatment for achalasia.
- •Contraindications for POEM (e.g., coagulopathy, portal hypertension).
- •Sigmoid Achalasia
结局指标
主要结局
Incidence of Gastro esophageal Reflux disease (GERD) after poem
时间窗: At 12 weeks and 52 weeks post-procedure
Comparison of gastroesophageal reflux disease incidence, assessed by manual review of esophageal acid exopsure and endoscopic findings, between conventional poem and two experimental short tunnel poem techinques in patients with type II achalasia
次要结局
- Eckardt symptom score(At 12 weeks and 52 weeks post-procedure)
- Total procedure time(Periprocedural (during the procedure))
- use of acid suppressants(Up to 1 year post-procedure)
- severity of esophagitis(At 12 weeks post procedure)
- intraoperative and post operative adverse events(Periprocedural and post-procedure)
- 36-Item Short Form Survey (SF-36)(At baseline (pre-procedure), 12 weeks, and 52 weeks post-procedure)
- Gastroesophageal Reflux Disease- Health Related Quality of Life questionnaire (GERD-HRQL)(At 12 weeks and 52 weeks post-procedure)
- Clinically relevant Gastroesophageal Reflux Disease Questionnaire (GERD-Q)(At 1 year post-procedure)
- duration of hospital stay(up to 1 week)
研究者
Mohan Ramchandani
MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist
Asian Institute of Gastroenterology, India
