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POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| snare group | Experimental | snare-assisted POEM |
|
| conventional group | Active Comparator | knife-assisted POEM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| snare-assisted POEM | Device | POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rates | Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011). | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related adverse events | Adverse events are defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon (Cotton PB et al, Gastrointest Endosc 2010). Incidental findings of pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion on postoperative imaging, and subcutaneous emphysema were documented while not considered as adverse events. | baseline to 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Xing, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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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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|
| knife-assisted POEM | Device | POEM is performed by using a conventional endoscopic knife.
|
|
| Procedure time | Procedure time is measured from the start of submucosal injection until mucosal entry closure. | POEM procedure |
| The volume of intraoperative bleeding | POEM procedure |
| The use of hemostatic forceps | POEM procedure |
| Postoperative pain requiring the use of tramadol | Pain related to POEM procedure requiring the use of tramadol pain medication. | Through hospital stay after procedure, an average of 2-7 days |
| The length of postoperative hospital stay | Through hospital stay after procedure, an average of 2-7 daysc |
| Total hospital costs of treatment per participants | Through hospital stay after procedure, an average of 2-7 days |
| Eckardt score | The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011). | baseline, 3 months and 12 months after treatment |
| Manometry parameters | Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry. | baseline and 3 months after treatment |
| Maximum esophageal diameter on barium esophagram | baseline and 3 months after treatment |
| Gastroesophageal reflux disease questionnaire (GerdQ) score | The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score >7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009). | baseline, 3 months and 12 months after treatment |
| Reflux esophagitis on post-POEM endoscopy | The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996). | 3 months after treatment |
| D004066 | Digestive System Diseases |