This trial is active, not recruiting.

Conditions achalasia, postoperative complications
Treatment peroral endoscopic myotomy
Phase phase 4
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Start date March 2012
End date December 2012
Trial size 40 participants
Trial identifier NCT01570621, DrumTower206-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

symptom relief
time frame: 1-12months
Lower esophageal sphincter pressure
time frame: 1-12months
improvement of esophageal barium
time frame: 1-12 months
Postoperative complications
time frame: 0-12months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Personalized Peroral Endoscopic Myotomy for Achalasia
Principal investigator Tingsheng Ling
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.