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临床试验/NCT07325071
NCT07325071尚未招募不适用

A Randomized Controlled Trial Comparing Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia

Asian Institute of Gastroenterology, India0 个研究点目标入组 636 人开始时间: 2025年12月31日最近更新:

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

  1. Clinical success based on Eckardt score
  2. Operating total procedure time
  3. Use of Acid Suppressants on Follow up at 1 year
  4. Severity of Esophagitis at 3 months
  5. Intraoperative & Postoperative adverse events (AGREE classification),
  6. GERD-HRQL (0-18) scores 3 & 12 Months
  7. (Clinically relevant GORD was defined as excessive oesophageal /AET associated with a GERDQ score >7 and/or with any grade of reflux oesophagitis).
  8. Duration of Hospital stay
  9. 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

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

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist

Asian Institute of Gastroenterology, India

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