Comparison of Short Versus Long Oesophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Single Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Comparison of clinical efficacy between short and long myotomy groups
研究概览
简要总结
Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy. Hypothesis is that performing short myotomy will result in similar efficacy in achalasia cardia while reducing the total time taken for the procedure and ultimately will result in less complications.
详细描述
The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cm in stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one, there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum. Additionally, there is chance that many patients regain some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind randomized clinical trial
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 and 2 achalasia with eckerd score >3 (0-12 scale achalasia) -.
- •Age 18-75 years.
- •Treatment naïve or history of pneumatic balloon dilatation.
- •Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
排除标准
- •Type 3 achalasia cardia or any other esophageal motility disorder
- •Previous surgery of the esophagus or stomach
- •Active severe esophagitis
- •Large lower esophageal diverticula
- •Large > 3cm hiatal hernia
- •Sigmoid esophagus
- •Known gastroesophageal malignancy
- •Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- •Cirrhosis with portal hypertension, varices, and/or ascites
结局指标
主要结局
Comparison of clinical efficacy between short and long myotomy groups
时间窗: 1 year
Clinical success defined as Eckardt score≤3 compared between the two groups
次要结局
- Difference in operating time between short and long esophageal myotomy during POEM(Intra-opeartive)
- Comparison of gastroesophageal Reflux disease (GERD) Rates(3 months)
- Intraoperative adverse events(At the time of index procedure)
- LES pressure reduction(1 and 3 months)
- Change in barium column height on barium esophagogram(1 and 3 months)
- Comparison of changes in Eckardt score(1, 3 and 12 months)
研究者
Mohan Ramchandani
Principal investigator
Asian Institute of Gastroenterology, India