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

N

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

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

Trial contacts and locations

1

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Central trial contact

Wei Gong, Doctor; Silin Huang, Master

Data sourced from clinicaltrials.gov

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