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AchalasiaNCT01405417

Endoscopic Peroral Myotomy for Treatment of Achalasia

A study testing Endoscopic Peroral Myotomy in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Achalasia
What is being tested?
Endoscopic Peroral Myotomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
5 sitesin 4 countries
Study dates
Apr 2011to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Malignant or premalignant esophageal lesion
  • Candida esophagitis
  • Hiatal hernia > 2cm

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Germany2 sites

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

    Frankfurt am Main, 60431

  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie

    Hamburg, 20246

Other trials in Germany

Canada1 site

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

    Montreal, Quebec, H3G 1A4

Other trials in Canada

Netherlands1 site

  • Department of Gastroenterology and Hepatology, Academic Medical Center

    Amsterdam, 1105 AZ

Other trials in Netherlands

Switzerland1 site

  • Klinik für Gastroenterologie, USZ

    Zurich

Other trials in Switzerland

About this study

Official title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study

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

Read the detailed description

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

70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.

Primary outcome:

-Eckhard 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, esophago-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. 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.

Conditions
Achalasia
Being tested
Endoscopic Peroral Myotomy
Keywords
Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
Medical subject headings
Esophageal Achalasia, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Peroral MyotomyProcedure or surgery

    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.

Study groups in NCT01405417
Study groupRoleWhat they receive
Peroral endoscopic myotomyExperimentalPatients 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.
Receives: Procedure: Endoscopic Peroral Myotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eckhard symptom score at 3 month after peroral endoscopic myotomy

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

    Measured: Score is evaluated at 3 month after peroral endoscopic myotomy

Secondary outcomes (2)

  1. Lower esophageal sphincter pressure

    Manometry study

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

  2. Reflux Symptoms

    Symptoms as reported by the patient

    Measured: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2012
  4. Study completionSep 2017

Why it stopped: not enough data collected

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405417
Sponsor's protocol ID
UKE HH Endoscopy PV3725mc
Status last verified
Apr 2019
First submitted
26 May 2011
Last updated
7 Jun 2019
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20354937

  • 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.

    PubMed 22068665

  • 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.

    PubMed 23665071

  • 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.

    PubMed 25934759

  • 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.

    PubMed 27609778

  • 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.

    PubMed 29546671

  • 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.

    PubMed 27747277

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Peroral Myotomy in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Canada, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: not enough data collected). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eckhard symptom score at 3 month after peroral endoscopic myotomy (time frame: Score is evaluated at 3 month after peroral endoscopic myotomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405417, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.

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