Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Peroral Endoscopic Myotomy
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: Peroral Endoscopic Myotomy (Other)
Outcomes
Primary Outcomes
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
Time Frame: 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.
Secondary Outcomes
- mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure(manometry at 3 month after therapy)
- 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 to 3 months post procedure)
- Medication 3 Months After POEM(3 months)
- Duration Time Procedure(procedure)
- Days Duration Hospitalization(days of hospitalization for POEM procedure, an average of 4 days)
- cm Myotomy Length(POEM procedure)
- Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment(3 months after treatment)