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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare. 4. The mucosal incision is closed with endoclips.
POEM is performed by using a conventional endoscopic knife. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife. 4. The mucosal incision is closed with endoclips.
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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).
Time frame: 12 months after treatment
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.
Time frame: baseline to 12 months after treatment
Procedure time
Procedure time is measured from the start of submucosal injection until mucosal entry closure.
Time frame: POEM procedure
The volume of intraoperative bleeding
Time frame: POEM procedure
The use of hemostatic forceps
Time frame: POEM procedure
Postoperative pain requiring the use of tramadol
Pain related to POEM procedure requiring the use of tramadol pain medication.
Time frame: Through hospital stay after procedure, an average of 2-7 days
The length of postoperative hospital stay
Time frame: Through hospital stay after procedure, an average of 2-7 daysc
Total hospital costs of treatment per participants
Time frame: Through hospital stay after procedure, an average of 2-7 days
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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).
Time frame: 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.
Time frame: baseline and 3 months after treatment
Maximum esophageal diameter on barium esophagram
Time frame: 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).
Time frame: 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).
Time frame: 3 months after treatment