Endoscopic Peroral Myotomy for Treatment of Achalasia (POEM)
Primary Purpose
Achalasia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Peroral Endoscopic Myotomy
Sponsored by
About this trial
This is an interventional treatment trial for Achalasia focused on measuring Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
Eligibility Criteria
Inclusion criteria:
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
- persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- Signed written informed consent.
Exclusion criteria:
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Candida esophagitis
- Hiatal hernia > 2cm
Sites / Locations
- Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peroral Endoscopic Myotomy
Arm Description
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment
Outcomes
Primary Outcome Measures
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.
Secondary Outcome Measures
mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure
esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure
Number of Participants With Reflux Symptoms
Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Number of Participants With Procedure-related Adverse Events
procedure-related adverse events per protocol
Medication 3 Months After POEM
proton pump inhibitor (PPI) use at 3 months after POEM procedure
Duration Time Procedure
duration time of POEM procedures in minutes
Days Duration Hospitalization
participants were followed for the duration of hospital stay, an average of 4 days
cm Myotomy Length
myotomy length in cm
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.
Full Information
NCT ID
NCT01405469
First Posted
May 26, 2011
Last Updated
October 6, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT01405469
Brief Title
Endoscopic Peroral Myotomy for Treatment of Achalasia
Acronym
POEM
Official Title
Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
Detailed Description
This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.
Primary outcome:
-eckhardt symptom score 3 month after therapy.
Secondary outcomes:
Lower esophageal sphincter pressure at 3 month after therapy.
Reflux symptoms at 3 month after therapy.
For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peroral Endoscopic Myotomy
Arm Type
Experimental
Arm Description
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment
Intervention Type
Other
Intervention Name(s)
Peroral Endoscopic Myotomy
Intervention Description
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips
Primary Outcome Measure Information:
Title
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
Description
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure
Description
esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure
Time Frame
manometry at 3 month after therapy
Title
Number of Participants With Reflux Symptoms
Description
Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Time Frame
during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Title
Number of Participants With Procedure-related Adverse Events
Description
procedure-related adverse events per protocol
Time Frame
procedure to 3 months post procedure
Title
Medication 3 Months After POEM
Description
proton pump inhibitor (PPI) use at 3 months after POEM procedure
Time Frame
3 months
Title
Duration Time Procedure
Description
duration time of POEM procedures in minutes
Time Frame
procedure
Title
Days Duration Hospitalization
Description
participants were followed for the duration of hospital stay, an average of 4 days
Time Frame
days of hospitalization for POEM procedure, an average of 4 days
Title
cm Myotomy Length
Description
myotomy length in cm
Time Frame
POEM procedure
Title
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
Description
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.
Time Frame
3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
Signed written informed consent.
Exclusion criteria:
Patients with previous surgery of the stomach or esophagus
Patients with known coagulopathy
Previous achalasia-treatment with surgery
Patients with liver cirrhosis and/or esophageal varices
Active esophagitis
Eosinophilic esophagitis
Barrett's esophagus
Pregnancy
Stricture of the esophagus
Malignant or premalignant esophageal lesion
Candida esophagitis
Hiatal hernia > 2cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Roesch, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
background
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
result
Links:
URL
http://www.uke.de/kliniken/endoskopie/index.php
Description
University Hospital Hamburg-Eppendorf, Endoscopy Department
Learn more about this trial
Endoscopic Peroral Myotomy for Treatment of Achalasia
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