- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768091
POEM vs. Pneumatic Dilation for Esophageal Achalasia
Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital of Southern Medical University
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Contact:
- Xiaobing Cui, M.D.
- Phone Number: +86 13631312723
- Email: xbing119@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between 18 and 75 years of age
- Patient with esophageal achalasia
- Eckardt score > 3
- Signed informed consent
Exclusion Criteria:
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus
- Previous endoscopic Botox injection
- Previous oesophageal or gastric surgery
- Pregnancy or lactation women, or ready to pregnant women
- Not capable of filling out questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: POEM
POEM for patients with esophageal achalasia
|
(Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271)
Other Names:
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Active Comparator: Pneumatic dilation
Pneumatic dilation for patients with esophageal achalasia
|
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.) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic success
Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years
|
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.) |
From date of randomization until the follow-up ended, assessed up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure related complication
Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years
|
Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
|
From date of randomization until the follow-up ended, assessed up to 2 years
|
Time of treatment failure
Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years
|
Time of treatment failure is defined as when the Eckardt score of patients are more than 3
|
From date of randomization until the follow-up ended, assessed up to 2 years
|
Pressure at the lower esophageal sphincter
Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years
|
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.
|
From date of randomization until the follow-up ended, assessed up to 2 years
|
Quality of life
Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years
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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
|
From date of randomization until the follow-up ended, assessed up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wei Gong, M.D., Department of Gastroenterology, Nanfang Hospital of Southern Medical University
Publications and helpful links
General Publications
- Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEC-201211-K2
- 201120 (New business and New Technology Project of Nanfang Hospital)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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