Endoscopic Peroral Myotomy for Treatment of Achalasia (POEM)

Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Achalasia
• Intervention / Treatment: Other: Peroral Endoscopic Myotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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

Other: Peroral Endoscopic Myotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	procedure to 3 months post procedure
Medication 3 Months After POEM	proton pump inhibitor (PPI) use at 3 months after POEM procedure	3 months
Duration Time Procedure	duration time of POEM procedures in minutes	procedure
Days Duration Hospitalization	participants were followed for the duration of hospital stay, an average of 4 days	days of hospitalization for POEM procedure, an average of 4 days
cm Myotomy Length	myotomy length in cm	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.	3 months after treatment

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• University Hospital Hamburg-Eppendorf, Endoscopy Department

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (ESTIMATE): July 29, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Dysphagia; Achalasia; Heller myotomy; Peroral Endoscopic Myotomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: UKE Hamburg Endoscopy PV3725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO