NCT01637311

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 11, 2012

Status Verified

May 1, 2012

Enrollment Period

2.9 years

First QC Date

July 3, 2012

Last Update Submit

July 6, 2012

Conditions

Esophageal Achalasia

Keywords

Peroral endoscopic myotomyHeller myotomypersistent/recurrent achalasia.

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

  • Procedure-related adverse events

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

  • Lower esophageal sphincter (LES) pressure on manometry

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

  • Reflux symptoms and medication use before and after POEM

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

Study Arms (1)

Failed HM

EXPERIMENTAL

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.

Procedure: POEM

Interventions

POEMPROCEDURE

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

Failed HM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, 200032, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 21522116BACKGROUND

  • 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.

    PMID: 11807357BACKGROUND

  • 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.

    PMID: 18025339BACKGROUND

  • 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.

    PMID: 16722998RESULT

  • 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.

    PMID: 12730729RESULT

  • 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.

    PMID: 17440784RESULT

  • 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: 20354937RESULT

  • 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: 22068665RESULT

  • 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.

    PMID: 22609984RESULT

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ping-Hong Zhou, MD,PhD

    Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Ping-Hong Zhou, MD,PhD

CONTACT

(+86)-21-64041990zhou1968@yahoo.cn

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

July 3, 2012

First Posted

July 11, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

July 11, 2012

Record last verified: 2012-05

Locations

CN(1)