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Personalized Peroral Endoscopic Myotomy for Achalasia (POEM)

Primary Purpose

Achalasia, Postoperative Complications

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
peroral endoscopic myotomy
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring achalasia, peroral endoscopic myotomy, LES pressure, postoperative complication, symptom relief, esophageal barium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Drum Tower Hospital

Outcomes

Primary Outcome Measures

symptom relief
compare patients' symptoms before and after POEM at 1 month, 12 months.
Lower esophageal sphincter pressure
compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
improvement of esophageal barium
compare esophageal barium before and after POEM at 1 months,12 months
Postoperative complications
postoperative complications

Secondary Outcome Measures

Full Information

First Posted
April 1, 2012
Last Updated
April 3, 2012
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01570621
Brief Title
Personalized Peroral Endoscopic Myotomy for Achalasia
Acronym
POEM
Official Title
Personalized Peroral Endoscopic Myotomy for Achalasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia, Postoperative Complications
Keywords
achalasia, peroral endoscopic myotomy, LES pressure, postoperative complication, symptom relief, esophageal barium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
peroral endoscopic myotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
symptom relief
Description
compare patients' symptoms before and after POEM at 1 month, 12 months.
Time Frame
1-12months
Title
Lower esophageal sphincter pressure
Description
compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
Time Frame
1-12months
Title
improvement of esophageal barium
Description
compare esophageal barium before and after POEM at 1 months,12 months
Time Frame
1-12 months
Title
Postoperative complications
Description
postoperative complications
Time Frame
0-12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingsheng Ling
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22068665
Citation
von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
Results Reference
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PubMed Identifier
20354937
Citation
Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
Results Reference
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Personalized Peroral Endoscopic Myotomy for Achalasia

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