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Completed

NCT Number: NCT02999451

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

snare-assisted POEM

Device

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

Device

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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