Personalized Peroral Endoscopic Myotomy for Achalasia (POEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01570621
First received: April 1, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.


Condition Intervention Phase
Achalasia
Postoperative Complications
Procedure: peroral endoscopic myotomy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Personalized Peroral Endoscopic Myotomy for Achalasia

Resource links provided by NLM:


Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • symptom relief [ Time Frame: 1-12months ] [ Designated as safety issue: No ]
    compare patients' symptoms before and after POEM at 1 month, 12 months.

  • Lower esophageal sphincter pressure [ Time Frame: 1-12months ] [ Designated as safety issue: No ]
    compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.

  • improvement of esophageal barium [ Time Frame: 1-12 months ] [ Designated as safety issue: No ]
    compare esophageal barium before and after POEM at 1 months,12 months

  • Postoperative complications [ Time Frame: 0-12months ] [ Designated as safety issue: Yes ]
    postoperative complications


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: peroral endoscopic myotomy
    A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
  • Age over 18 years old
  • Signed written informed consent

Exclusion Criteria:

  • Patients with previous surgery of the stomach or esophagus
  • With known coagulopathy
  • Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Hiatal hernia > 2cm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570621

Locations
China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Tingsheng Ling Nanjing Drum Tower Hospital
  More Information

Publications:
Responsible Party: Zou Xiaoping, vice-principal, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01570621     History of Changes
Other Study ID Numbers: DrumTower206-01
Study First Received: April 1, 2012
Last Updated: April 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
achalasia
peroral endoscopic myotomy
LES pressure
postoperative complication
symptom relief
esophageal barium

Additional relevant MeSH terms:
Postoperative Complications
Esophageal Achalasia
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014