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| ID | Type | Description | Link |
|---|---|---|---|
| 201120 | Other Grant/Funding Number | New business and New Technology Project of Nanfang Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POEM | Experimental | POEM for patients with esophageal achalasia |
|
| Pneumatic dilation | Active Comparator | Pneumatic dilation for patients with esophageal achalasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POEM | Procedure |
(Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271) |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic success | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure related complication | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Gong, M.D. | Contact | +86 15820290385 | gwei203@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Gong, M.D. | Department of Gastroenterology, Nanfang Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20354937 | Background | 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. | |
| 21561346 | Background | 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. |
| Label | URL |
|---|---|
| Homepage of Nanfang Hospital of Southern Medical University | View source |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Pneumatic dilation | Procedure | 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.) |
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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 | 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 | 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 |
| Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University | View source |
| D004066 | Digestive System Diseases |