NCT01405417

Brief Summary

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 7, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

May 26, 2011

Last Update Submit

June 5, 2019

Conditions

Achalasia

Keywords

AchalasiaHeller myotomyDysphagiaPeroral Endoscopic Myotomy

Outcome Measures

Primary Outcomes (1)

  • Eckhard symptom score at 3 month after peroral endoscopic myotomy

    Validated symptom score based on dysphagia, pain, regurgitation and weight loss

    Score is evaluated at 3 month after peroral endoscopic myotomy

Secondary Outcomes (2)

  • Lower esophageal sphincter pressure

    Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy

  • Reflux Symptoms

    Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy

Study Arms (1)

Peroral endoscopic myotomy

EXPERIMENTAL

Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy. 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. A electrogenerator 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.

Procedure: Endoscopic Peroral Myotomy

Interventions

Endoscopic Peroral MyotomyPROCEDURE

Endoscopic peroral 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. A electrogenerator 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie

Hamburg, 20246, Germany

Location

Department of Gastroenterology and Hepatology, Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Klinik für Gastroenterologie, USZ

Zurich, Switzerland

Location

Related Publications (7)

  • 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: 20354937BACKGROUND

  • 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: 22068665BACKGROUND

  • Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9.

    PMID: 23665071RESULT

  • Werner YB, Costamagna G, Swanstrom LL, von Renteln D, Familiari P, Sharata AM, Noder T, Schachschal G, Kersten JF, Rosch T. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016 Jun;65(6):899-906. doi: 10.1136/gutjnl-2014-308649. Epub 2015 Apr 30.

    PMID: 25934759RESULT

  • Werner YB, von Renteln D, Noder T, Schachschal G, Denzer UW, Groth S, Nast JF, Kersten JF, Petzoldt M, Adam G, Mann O, Repici A, Hassan C, Rosch T. Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 10.1016/j.gie.2016.08.033. Epub 2016 Sep 5.

    PMID: 27609778RESULT

  • Nast JF, Berliner C, Rosch T, von Renteln D, Noder T, Schachschal G, Groth S, Ittrich H, Kersten JF, Adam G, Werner YB. Endoscopy versus radiology in post-procedural monitoring after peroral endoscopic myotomy (POEM). Surg Endosc. 2018 Sep;32(9):3956-3963. doi: 10.1007/s00464-018-6137-9. Epub 2018 Mar 15.

    PMID: 29546671DERIVED

  • Verlaan T, Ponds FA, Bastiaansen BA, Bredenoord AJ, Fockens P. Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM). Endosc Int Open. 2016 Oct;4(10):E1052-E1056. doi: 10.1055/s-0042-113126. Epub 2016 Sep 21.

    PMID: 27747277DERIVED

Related Links

MeSH Terms

Conditions

Esophageal AchalasiaDeglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Thomas Roesch, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department

Study Record Dates

First Submitted

May 26, 2011

First Posted

July 29, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2017

Last Updated

June 7, 2019

Record last verified: 2019-04

Locations

NL(1)CA(1)DE(2)CH(1)