Endoscopic Peroral Myotomy for Treatment of Achalasia

Not Applicable

Completed

Conditions: Achalasia

Interventions: Other: Peroral Endoscopic Myotomy

Registration Number: NCT01405469

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peroral Endoscopic Myotomy	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

Primary Outcome Measures

Name	Time	Method
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3	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 Outcome Measures

Name	Time	Method
mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure	manometry at 3 month after therapy	esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure
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 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	procedure-related adverse events per protocol
Medication 3 Months After POEM	3 months	proton pump inhibitor (PPI) use at 3 months after POEM procedure
Duration Time Procedure	procedure	duration time of POEM procedures in minutes
Days Duration Hospitalization	days of hospitalization for POEM procedure, an average of 4 days	participants were followed for the duration of hospital stay, an average of 4 days
cm Myotomy Length	POEM procedure	myotomy length in cm
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment	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.