Personalized Peroral Endoscopic Myotomy for Achalasia

Phase 4

• Conditions: Achalasia; Postoperative Complications

• Registration Number: NCT01570621
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-01
• Study First Submitted QC: 2012-04-03
• Last Update Submitted: 2012-04-03
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
symptom relief	1-12months	compare patients' symptoms before and after POEM at 1 month, 12 months.
Lower esophageal sphincter pressure	1-12months	compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
improvement of esophageal barium	1-12 months	compare esophageal barium before and after POEM at 1 months,12 months
Postoperative complications	0-12months	postoperative complications

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China