Endoscopic Peroral Myotomy for Treatment of Achalasia

NCT01405469 | Completed Results DMC

• 1 other identifier: UKE Hamburg Endoscopy PV3725
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Keywords

Achalasia; Heller myotomy; Dysphagia; Peroral Endoscopic Myotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Peroral Endoscopic Myotomy

EXPERIMENTAL

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

Interventions

Peroral Endoscopic Myotomy OTHER

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

Peroral Endoscopic Myotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie

Hamburg, 20246, Germany

Location

Related Publications (2)

• 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.

  PMID: 20354937 BACKGROUND

• 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.

  PMID: 22068665 RESULT

Related Links

• University Hospital Hamburg-Eppendorf, Endoscopy Department

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Prof. Dr. Thomas Rösch, Principal Investigator
• Organization: University Hospital Hamburg-Eppendorf

t.roesch@uke.de

+49 40 7410 50098

Study Officials

• Thomas Roesch, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: July 29, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2016
• Last Updated: October 15, 2019
• Results First Posted: December 2, 2014

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)