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

April 1, 2012
April 3, 2012
March 2012
December 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01570621 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Personalized Peroral Endoscopic Myotomy for Achalasia
Personalized Peroral Endoscopic Myotomy for Achalasia

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Achalasia
  • Postoperative Complications
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01570621
DrumTower206-01
Yes
Zou Xiaoping, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Not Provided
Principal Investigator: Tingsheng Ling Nanjing Drum Tower Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP