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Esophageal AchalasiaPOEM2NCT02572193

To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

A study testing POEM in people with Esophageal Achalasia, run by McMaster University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Achalasia
What is being tested?
POEM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Oct 2015to Dec 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet ALL of the following inclusion criteria:
  • Candidate for a Heller myotomy
  • Their age is ≥18 years and ≤80 years
  • Able to give written consent

Who cannot join

  • Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
  • Previous Heller myotomy or POEM procedure
  • contra-indication to general anesthesia
  • Previous mediastinal surgery hiatal hernia greater than 2 cm
  • Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm.
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Trial locations and contacts

1 site in 1 country.

Dennis Hong, MD contact

905-522-1155 ext. 32938

dennishong70@gmail.com

Canada1 site, 1 recruiting

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    Dennis Hong, MD

    Recruiting

Other trials in Canada

About this study

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.

Read the detailed description

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus.

Standard care for participants includes Heller Myotomy, a laparoscopic procedure that includes cutting the muscle layers in the lower esophageal sphincter (LES) the valve at the bottom of your esophagus. A second procedure is then required to prevent reflux (acid entering the esophagus from the stomach) called fundoplication. Patients with the Heller myotomy will typically stay overnight in hospital. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This procedure uses endoscopy and no incisions to cut one muscle layer. A fundoplication is not required with this method. This study treatment works by entering the surgical area through the mouth and then making an incision (cut) through the esophagus and placing flexible instruments along the outside of the esophagus and down to the LES through a tunnel. The instruments used in this procedure are standard endoscopic instruments that will be provided by one of the leading endoscopic instrument manufacturers, Olympus. The investigators have recently completed a small study showing this procedure is safe and feasible. One observation from this pilot study was that most patients had no pain and didn't need any pain medications. Due to this reason, the investigators think patient's may go home on the same day as their procedure.

Being tested
POEM
Keywords
achalasia, surgery
Medical subject headings
Esophageal Achalasia

What participants receive

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

  • POEMProcedure or surgery

    To determine the feasibility of same-day discharge following a POEM procedure

Study groups in NCT02572193
Study groupRoleWhat they receive
Active caseExperimentalPOEM procedure
Receives: Procedure: POEM

What is being measured

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

  1. percent of patients leaving on post-operative day 0

    Measured: 1 year

Secondary outcomes (1)

  1. percent of patients who experience post-operative reflux

    Measured: 1 year

Timeline

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

  1. First posted8 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572193
Sponsor's protocol ID
2015H1
Acronym
POEM2
Status last verified
Dec 2016
First submitted
6 Oct 2015
Last updated
16 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Shiwaku H, Inoue H, Sasaki T, Yamashita K, Ohmiya T, Takeno S, Nimura S, Yamashita Y. A prospective analysis of GERD after POEM on anterior myotomy. Surg Endosc. 2016 Jun;30(6):2496-504. doi: 10.1007/s00464-015-4507-0. Epub 2015 Sep 28.

    PubMed 26416381

  • Barbieri LA, Hassan C, Rosati R, Romario UF, Correale L, Repici A. Systematic review and meta-analysis: Efficacy and safety of POEM for achalasia. United European Gastroenterol J. 2015 Aug;3(4):325-34. doi: 10.1177/2050640615581732.

    PubMed 26279840

  • Inoue H, Sato H, Ikeda H, Onimaru M, Sato C, Minami H, Yokomichi H, Kobayashi Y, Grimes KL, Kudo SE. Per-Oral Endoscopic Myotomy: A Series of 500 Patients. J Am Coll Surg. 2015 Aug;221(2):256-64. doi: 10.1016/j.jamcollsurg.2015.03.057. Epub 2015 Apr 11.

    PubMed 26206634

  • Stavropoulos SN, Modayil R, Friedel D. Per oral endoscopic myotomy for the treatment of achalasia. Curr Opin Gastroenterol. 2015 Sep;31(5):430-40. doi: 10.1097/MOG.0000000000000206.

    PubMed 26200001

  • Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Epub 2015 Jul 14.

    PubMed 26175119

Questions about this trial

What is this clinical trial studying?

A study testing POEM in people with Esophageal Achalasia, run by McMaster University at 1 site in Canada.

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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Results are not available in the source record.

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

Contact Dennis Hong, MD (905-522-1155 ext. 32938, dennishong70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percent of patients leaving on post-operative day 0 (time frame: 1 year). 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 NCT02572193, which also lists 5 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 16 Dec 2016.

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