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Esophageal AchalasiaNCT01637311

Peroral Endoscopic Remyotomy for Failed Heller Myotomy

A study testing POEM in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the… 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
20 participants
Where
1 siteChina
Study dates
Jan 2010to Dec 2014
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

  • Age greater than 18 years
  • Recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4
  • The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)

Who cannot join

  • Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
  • Pseudoachalasia
  • megaesophagus (diameter of > 7 cm)

Trial locations and contacts

1 site in 1 country.

Ping-Hong Zhou, MD,PhD contact

(+86)-21-64041990

zhou1968@yahoo.cn

China1 site, 1 recruiting

  • Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University

    Shanghai, 200032

    Ping-Hong Zhou, MD,PhD, (+86)-21-64041990, zhou1968@yahoo.cn

    Ping-Hong Zhou, MD,PhD

    Recruiting

Other trials in China

About this study

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. Although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients with failed HM.

Read the detailed description
  1. Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of > 7 cm).
  2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
  3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.
Being tested
POEM
Keywords
Peroral endoscopic myotomy, Heller myotomy, persistent/recurrent achalasia.
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

    Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.

Study groups in NCT01637311
Study groupRoleWhat they receive
Failed HMExperimentalPatients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4.
Receives: Procedure: POEM

What is being measured

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

  1. Therapeutic success (a reduction in the Eckardt score to ≤3)

    Measured: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.

Secondary outcomes (3)

  1. Procedure-related adverse events

    Measured: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.

  2. Lower esophageal sphincter (LES) pressure on manometry

    Measured: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry

  3. Reflux symptoms and medication use before and after POEM

    Measured: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.

Timeline

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

  1. First posted11 Jul 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2014 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01637311
Sponsor's protocol ID
ZSNJ-POEM
Status last verified
May 2012
First submitted
3 Jul 2012
Last updated
11 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Eckardt AJ, Eckardt VF. Treatment and surveillance strategies in achalasia: an update. Nat Rev Gastroenterol Hepatol. 2011 Jun;8(6):311-9. doi: 10.1038/nrgastro.2011.68. Epub 2011 Apr 26.

    PubMed 21522116

  • Zaninotto G, Costantini M, Portale G, Battaglia G, Molena D, Carta A, Costantino M, Nicoletti L, Ancona E. Etiology, diagnosis, and treatment of failures after laparoscopic Heller myotomy for achalasia. Ann Surg. 2002 Feb;235(2):186-92. doi: 10.1097/00000658-200202000-00005.

    PubMed 11807357

  • Gockel I, Junginger T, Eckardt VF. Persistent and recurrent achalasia after Heller myotomy: analysis of different patterns and long-term results of reoperation. Arch Surg. 2007 Nov;142(11):1093-7. doi: 10.1001/archsurg.142.11.1093.

    PubMed 18025339

  • Iqbal A, Tierney B, Haider M, Salinas VK, Karu A, Turaga KK, Mittal SK, Filipi CJ. Laparoscopic re-operation for failed Heller myotomy. Dis Esophagus. 2006;19(3):193-9. doi: 10.1111/j.1442-2050.2006.00564.x.

    PubMed 16722998

  • Duffy PE, Awad ZT, Filipi CJ. The laparoscopic reoperation of failed Heller myotomy. Surg Endosc. 2003 Jul;17(7):1046-9. doi: 10.1007/s00464-002-8570-y. Epub 2003 May 7.

    PubMed 12730729

  • Rakita S, Villadolid D, Kalipersad C, Thometz D, Rosemurgy A. Outcomes promote reoperative Heller myotomy for symptoms of achalasia. Surg Endosc. 2007 Oct;21(10):1709-14. doi: 10.1007/s00464-007-9226-8. Epub 2007 Apr 14.

    PubMed 17440784

  • 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

  • Ren Z, Zhong Y, Zhou P, Xu M, Cai M, Li L, Shi Q, Yao L. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc. 2012 Nov;26(11):3267-72. doi: 10.1007/s00464-012-2336-y. Epub 2012 May 19.

    PubMed 22609984

Questions about this trial

What is this clinical trial studying?

A study testing POEM in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.

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 3 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 11 Jul 2012. 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 China. 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 Ping-Hong Zhou, MD,PhD ((+86)-21-64041990, zhou1968@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic success (a reduction in the Eckardt score to ≤3) (time frame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.). 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 NCT01637311, which also lists 9 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 11 Jul 2012.

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