POEM vs. Pneumatic Dilation for Esophageal Achalasia

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Esophageal Achalasia

Treatments: Procedure: POEM; Procedure: Pneumatic dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01768091

201120 (Other Grant/Funding Number)

NFEC-201211-K2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 18 and 75 years of age
• Patient with esophageal achalasia
• Eckardt score > 3
• Signed informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

POEM

Experimental group

Description:

POEM for patients with esophageal achalasia

Treatment:

Procedure: POEM

Pneumatic dilation

Active Comparator group

Description:

Pneumatic dilation for patients with esophageal achalasia

Treatment:

Procedure: Pneumatic dilation