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

Not Applicable

• Conditions: Esophageal Achalasia; Esophageal Motility Disorders
• Interventions: Procedure: short-myotomy; Procedure: full-thickness myotomy; Procedure: circular myotomy; Procedure: long-myotomy

• Registration Number: NCT03012854
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short-myotomy	short-myotomy	Short-POEM for patients with esophageal achalasia
full-thickness myotomy	full-thickness myotomy	Full-thickness-POEM for patients with esophageal achalasia
circular myotomy	circular myotomy	Circular-POEM for patients with esophageal achalasia
long-myotomy	long-myotomy	Long-POEM 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 5 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
Time of treatment failure	From date of randomization until the follow-up ended, assessed up to 5 years	Time of treatment failure is defined as when the Eckardt score of patients are more than 3.
Procedure related complication	From date of randomization until the follow-up ended, assessed up to 5 years	Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
Pressure at the lower esophageal sphincter	From date of randomization until the follow-up ended, assessed up to 5 years	From date of randomization until the follow-up ended, assessed up to 5 years
Quality of life	From date of randomization until the follow-up ended, assessed up to 5 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; 🇨🇳 Guanzhou, Guangdong, China