POEM vs. Pneumatic Dilation for Esophageal Achalasia
- Conditions
- Esophageal Achalasia
- Interventions
- Procedure: POEMProcedure: Pneumatic dilation
- Registration Number
- NCT01768091
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.
- Detailed Description
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.
Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.
Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.
However, the long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Between 18 and 75 years of age
- Patient with esophageal achalasia
- Eckardt score > 3
- Signed informed consent
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus
- Previous endoscopic Botox injection
- Previous oesophageal or gastric surgery
- Pregnancy or lactation women, or ready to pregnant women
- Not capable of filling out questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description POEM POEM POEM for patients with esophageal achalasia Pneumatic dilation Pneumatic dilation Pneumatic dilation for patients with esophageal achalasia
- Primary Outcome Measures
Name Time Method Therapeutic success From date of randomization until the follow-up ended, assessed up to 2 years Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less.
The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
- Secondary Outcome Measures
Name Time Method Procedure related complication From date of randomization until the follow-up ended, assessed up to 2 years Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
Time of treatment failure From date of randomization until the follow-up ended, assessed up to 2 years Time of treatment failure is defined as when the Eckardt score of patients are more than 3
Pressure at the lower esophageal sphincter From date of randomization until the follow-up ended, assessed up to 2 years The basal LES pressure and the swallow-induced LES relaxation will be monitored and measured at the end of expiration. After introduction and equilibration, basal pressure is monitored during at least 5 minutes. Swallow-induced relaxation of the sphincter is assessed by 5 ml wet swallows, at least 30 s apart.
Quality of life From date of randomization until the follow-up ended, assessed up to 2 years Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life
Trial Locations
- Locations (1)
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China