Personalized Peroral Endoscopic Myotomy for Achalasia (POEM)

Nanjing University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Complications; Achalasia

Treatments: Procedure: peroral endoscopic myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01570621

DrumTower206-01

Details and patient eligibility

About

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
• Age over 18 years old
• Signed written informed consent

Exclusion criteria

• Patients with previous surgery of the stomach or esophagus
• With known coagulopathy
• Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
• Pregnancy
• Stricture of the esophagus
• Hiatal hernia > 2cm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)