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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, Germany
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.
Time frame: 3 months after treatment
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
Time frame: manometry at 3 month after therapy
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
Time frame: 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
Time frame: procedure to 3 months post procedure
Medication 3 Months After POEM
proton pump inhibitor (PPI) use at 3 months after POEM procedure
Time frame: 3 months
Duration Time Procedure
duration time of POEM procedures in minutes
Time frame: procedure
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Days Duration Hospitalization
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
cm Myotomy Length
myotomy length in cm
Time frame: POEM procedure
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.
Time frame: 3 months after treatment