Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Esophageal Motility Disorders; Esophageal Achalasia

Treatments: Procedure: long-myotomy; Procedure: full-thickness myotomy; Procedure: short-myotomy; Procedure: circular myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03012854

NFEC-2016-186

Details and patient eligibility

About

This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

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 clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between 18 and 75 years of age;
2. Patient with esophageal achalasia;
3. Eckardt score > 3;
4. Signed informed consent.

Exclusion criteria

1. Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk;
2. Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus;
3. Previous endoscopic Botox injection;
4. Previous oesophageal or gastric surgery;
5. Pregnancy or lactation women, or ready to pregnant women;
6. Not capable of filling out questionnaires.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

short-myotomy

Experimental group

Description:

Short-POEM for patients with esophageal achalasia

Treatment:

Procedure: short-myotomy

long-myotomy

Active Comparator group

Description:

Long-POEM for patients with esophageal achalasia

Treatment:

Procedure: long-myotomy

full-thickness myotomy

Experimental group

Description:

Full-thickness-POEM for patients with esophageal achalasia

Treatment:

Procedure: full-thickness myotomy

circular myotomy

Active Comparator group

Description:

Circular-POEM for patients with esophageal achalasia

Treatment:

Procedure: circular myotomy