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Snare-assisted POEM for Treatment of Esophageal Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02999451
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Xiangbin Xing, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Device: snare-assisted POEM Device: knife-assisted POEM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.

  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.

Active Comparator: conventional group
knife-assisted POEM
Device: knife-assisted POEM

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Procedure time [ Time Frame: POEM procedure ]
    Procedure time is measured from the start of submucosal injection until mucosal entry closure.

  3. The volume of intraoperative bleeding [ Time Frame: POEM procedure ]
  4. The use of hemostatic forceps [ Time Frame: POEM procedure ]
  5. 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.

  6. The length of postoperative hospital stay [ Time Frame: Through hospital stay after procedure, an average of 2-7 daysc ]
  7. Total hospital costs of treatment per participants [ Time Frame: Through hospital stay after procedure, an average of 2-7 days ]
  8. 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).

  9. 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.

  10. Maximum esophageal diameter on barium esophagram [ Time Frame: baseline and 3 months after treatment ]
  11. 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).

  12. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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China, Guangdong
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: Xiangbin Xing, MD, PhD First Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Xiangbin Xing, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02999451    
Other Study ID Numbers: 123
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangbin Xing, First Affiliated Hospital, Sun Yat-Sen University:
Peroral endoscopic myotomy
Snare
Endoscopic knife
Esophageal Achalasia
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases