Snare-assisted POEM for Treatment of Esophageal Achalasia

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

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 Overview

• Status: Completed
• Conditions: Esophageal Achalasia
• Intervention / Treatment: Device: snare-assisted POEM; Device: knife-assisted POEM

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 > Ⅲ
• Previous endoscopic or surgical treatment for achalasia
• Esophageal malignancy
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: snare group; snare-assisted POEM	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.
ACTIVE_COMPARATOR: conventional group; knife-assisted POEM	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Xiangbin Xing, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Peroral endoscopic myotomy; Snare; Endoscopic knife; Esophageal Achalasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No