Snare-assisted POEM for Treatment of Esophageal Achalasia

Esophageal Achalasia Clinical Trial

Official title:

Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999451
• Other study ID #: 123
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18-70 years

• Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy

• Signed written informed consent

Exclusion Criteria:

• ASA class > ?

• Previous endoscopic or surgical treatment for achalasia

• Esophageal malignancy

• Pregnant

Related Conditions & MeSH terms

• Esophageal Achalasia

Intervention

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. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare. The mucosal incision is closed with endoclips.
• knife-assisted POEM
POEM is performed by using a conventional endoscopic knife. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife. The mucosal incision is closed with endoclips.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Procedure time	Procedure time is measured from the start of submucosal injection until mucosal entry closure.	POEM procedure
Secondary	The volume of intraoperative bleeding		POEM procedure
Secondary	The use of hemostatic forceps		POEM procedure
Secondary	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
Secondary	The length of postoperative hospital stay		Through hospital stay after procedure, an average of 2-7 daysc
Secondary	Total hospital costs of treatment per participants		Through hospital stay after procedure, an average of 2-7 days
Secondary	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
Secondary	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
Secondary	Maximum esophageal diameter on barium esophagram		baseline and 3 months after treatment
Secondary	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
Secondary	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