Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia (POETA)
Primary Purpose
Esophageal Achalasia
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Endoscopic intervention A
Endoscopic intervention B
Endoscopic intervention C
Laparoscopic Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Achalasia
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Exclusion Criteria:
- Contraindication for EGD
Sites / Locations
- Department of Surgery, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Per oral endoscopic therapy A
Per oral endoscopic therapy B
Per oral endoscopic therapy C
Laparoscopic surgery
Arm Description
Per oral endoscopic myotomy
Prolonged dilatation by implantation of large diameter stents.
Dilatation
Laparoscopic Heller myotomy
Outcomes
Primary Outcome Measures
Achalasia specific symptoms according to the Eckardt score (0-12)
Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
Secondary Outcome Measures
Barium column height (cm) in esophagogram
Resting pressure (mmHg) at the lower esophageal sphincter
Stent migration
Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry
Full Information
NCT ID
NCT02518542
First Posted
December 8, 2014
Last Updated
August 7, 2015
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02518542
Brief Title
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
Acronym
POETA
Official Title
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.
Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.
Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.
The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Per oral endoscopic therapy A
Arm Type
Active Comparator
Arm Description
Per oral endoscopic myotomy
Arm Title
Per oral endoscopic therapy B
Arm Type
Active Comparator
Arm Description
Prolonged dilatation by implantation of large diameter stents.
Arm Title
Per oral endoscopic therapy C
Arm Type
Active Comparator
Arm Description
Dilatation
Arm Title
Laparoscopic surgery
Arm Type
Active Comparator
Arm Description
Laparoscopic Heller myotomy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic intervention A
Intervention Description
POEM: Per oral endoscopic myotomy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic intervention B
Intervention Description
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic intervention C
Intervention Description
Endoscopic balloon dilatation
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Surgery
Intervention Description
Laparoscopic Heller myotomy
Primary Outcome Measure Information:
Title
Achalasia specific symptoms according to the Eckardt score (0-12)
Description
Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
Time Frame
6 mo post-op
Secondary Outcome Measure Information:
Title
Barium column height (cm) in esophagogram
Time Frame
6 mo post-op
Title
Resting pressure (mmHg) at the lower esophageal sphincter
Time Frame
6 mo post-op
Title
Stent migration
Description
Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.
Time Frame
p.o. day 1
Title
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry
Time Frame
6 mo post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Exclusion Criteria:
Contraindication for EGD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Department of Surgery, Medical University of Vienna
Phone
+43 1 40400
Ext
5621
Email
sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at
Facility Information:
Facility Name
Department of Surgery, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian F Schoppmann, MD
Phone
+43 1 40400
Ext
5621
Email
sebastian.schoppmann@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Erwin Rieder, MD
Phone
+43 1 40400
Ext
5621
Email
erwin.rieder@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
We'll reach out to this number within 24 hrs