POEM vs. Pneumatic Dilation for Esophageal Achalasia
The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial|
- Therapeutic success [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]
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.)
- Procedure related complication [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
- Time of treatment failure [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]Time of treatment failure is defined as when the Eckardt score of patients are more than 3
- Pressure at the lower esophageal sphincter [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]The basal LES pressure and the swallow-induced LES relaxation will be monitored and measured at the end of expiration. After introduction and equilibration, basal pressure is monitored during at least 5 minutes. Swallow-induced relaxation of the sphincter is assessed by 5 ml wet swallows, at least 30 s apart.
- Quality of life [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]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
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
POEM for patients with esophageal achalasia
(Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271)
Other Name: Peroral endoscopic myotomy
Active Comparator: Pneumatic dilation
Pneumatic dilation for patients with esophageal achalasia
Procedure: Pneumatic dilation
A Rigiflex balloon (30 mm) was positioned at the esophagogastric junction and dilated at a pressure of 5 PSI for 1 minute, followed by 8 PSI for 1 minute.
(N Engl J Med 2011;364:1807-16.)
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 long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768091
|Contact: Wei Gong, M.D.||+86 email@example.com|
|Nanfang Hospital of Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Xiaobing Cui, M.D. +86 13631312723 firstname.lastname@example.org|
|Principal Investigator:||Wei Gong, M.D.||Department of Gastroenterology, Nanfang Hospital of Southern Medical University|