Snare-assisted POEM for Treatment of Esophageal Achalasia
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|ClinicalTrials.gov Identifier: NCT02999451|
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Device: snare-assisted POEM Device: knife-assisted POEM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: snare group
Device: snare-assisted POEM
POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
Active Comparator: conventional group
Device: knife-assisted POEM
POEM is performed by using a conventional endoscopic knife.
- Clinical success rates [ Time Frame: 12 months after treatment ]Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
- Procedure-related adverse events [ Time Frame: baseline to 12 months after treatment ]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.
- Procedure time [ Time Frame: POEM procedure ]Procedure time is measured from the start of submucosal injection until mucosal entry closure.
- 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 [ Time Frame: Through hospital stay after procedure, an average of 2-7 days ]Pain related to POEM procedure requiring the use of tramadol pain medication.
- 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 ]
- Eckardt score [ Time Frame: baseline, 3 months and 12 months after treatment ]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).
- Manometry parameters [ Time Frame: baseline and 3 months after treatment ]Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.
- Maximum esophageal diameter on barium esophagram [ Time Frame: baseline and 3 months after treatment ]
- Gastroesophageal reflux disease questionnaire (GerdQ) score [ Time Frame: baseline, 3 months and 12 months after treatment ]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).
- Reflux esophagitis on post-POEM endoscopy [ Time Frame: 3 months after treatment ]The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999451
|First Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Study Director:||Xiangbin Xing, MD, PhD||First Affiliated Hospital, Sun Yat-Sen University|