Snare-assisted POEM for Treatment of Esophageal Achalasia
Primary Purpose
Esophageal Achalasia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
snare-assisted POEM
knife-assisted POEM
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Achalasia focused on measuring Peroral endoscopic myotomy, Snare, Endoscopic knife, Esophageal Achalasia
Eligibility Criteria
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
Sites / Locations
- First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
snare group
conventional group
Arm Description
snare-assisted POEM
knife-assisted POEM
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Procedure time
Procedure time is measured from the start of submucosal injection until mucosal entry closure.
The volume of intraoperative bleeding
The use of hemostatic forceps
Postoperative pain requiring the use of tramadol
Pain related to POEM procedure requiring the use of tramadol pain medication.
The length of postoperative hospital stay
Total hospital costs of treatment per participants
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).
Manometry parameters
Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.
Maximum esophageal diameter on barium esophagram
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).
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).
Full Information
NCT ID
NCT02999451
First Posted
November 29, 2016
Last Updated
June 26, 2020
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02999451
Brief Title
Snare-assisted POEM for Treatment of Esophageal Achalasia
Official Title
Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
Keywords
Peroral endoscopic myotomy, Snare, Endoscopic knife, Esophageal Achalasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
snare group
Arm Type
Experimental
Arm Description
snare-assisted POEM
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
knife-assisted POEM
Intervention Type
Device
Intervention Name(s)
snare-assisted POEM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
knife-assisted POEM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical success rates
Description
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
Secondary Outcome Measure Information:
Title
Procedure-related adverse events
Description
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
Title
Procedure time
Description
Procedure time is measured from the start of submucosal injection until mucosal entry closure.
Time Frame
POEM procedure
Title
The volume of intraoperative bleeding
Time Frame
POEM procedure
Title
The use of hemostatic forceps
Time Frame
POEM procedure
Title
Postoperative pain requiring the use of tramadol
Description
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
Title
The length of postoperative hospital stay
Time Frame
Through hospital stay after procedure, an average of 2-7 daysc
Title
Total hospital costs of treatment per participants
Time Frame
Through hospital stay after procedure, an average of 2-7 days
Title
Eckardt score
Description
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
Title
Manometry parameters
Description
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
Title
Maximum esophageal diameter on barium esophagram
Time Frame
baseline and 3 months after treatment
Title
Gastroesophageal reflux disease questionnaire (GerdQ) score
Description
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
Title
Reflux esophagitis on post-POEM endoscopy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Xing, MD, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Snare-assisted POEM for Treatment of Esophageal Achalasia
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