Personalized Peroral Endoscopic Myotomy for Achalasia (POEM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01570621
Recruitment Status : Unknown
Verified April 2012 by Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruitment status was: Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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.
A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
Age over 18 years old
Signed written informed consent
Patients with previous surgery of the stomach or esophagus
With known coagulopathy
Active esophagitis,eosinophilic esophagitis or Barrett's esophagus