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Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Primary Purpose

Esophageal Achalasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
POEM
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Achalasia focused on measuring Peroral endoscopic myotomy, Heller myotomy, persistent/recurrent achalasia.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Failed HM

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedure-related adverse events
Lower esophageal sphincter (LES) pressure on manometry
Reflux symptoms and medication use before and after POEM

Full Information

First Posted
July 3, 2012
Last Updated
July 6, 2012
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01637311
Brief Title
Peroral Endoscopic Remyotomy for Failed Heller Myotomy
Official Title
Peroral Endoscopic Remyotomy for Failed Heller Myotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
Keywords
Peroral endoscopic myotomy, Heller myotomy, persistent/recurrent achalasia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Failed HM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
POEM
Intervention Description
Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Procedure-related adverse events
Time Frame
All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.
Title
Lower esophageal sphincter (LES) pressure on manometry
Time Frame
All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry
Title
Reflux symptoms and medication use before and after POEM
Time Frame
Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk Pseudoachalasia megaesophagus (diameter of > 7 cm)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Hong Zhou, MD,PhD
Phone
(+86)-21-64041990
Email
zhou1968@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD
Organizational Affiliation
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China
Official's Role
Study Director
Facility Information:
Facility Name
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD
Phone
(+86)-21-64041990
Email
zhou1968@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21522116
Citation
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.
Results Reference
background
PubMed Identifier
11807357
Citation
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.
Results Reference
background
PubMed Identifier
18025339
Citation
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.
Results Reference
background
PubMed Identifier
16722998
Citation
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.
Results Reference
result
PubMed Identifier
12730729
Citation
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.
Results Reference
result
PubMed Identifier
17440784
Citation
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.
Results Reference
result
PubMed Identifier
20354937
Citation
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.
Results Reference
result
PubMed Identifier
22068665
Citation
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.
Results Reference
result
PubMed Identifier
22609984
Citation
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.
Results Reference
result

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Peroral Endoscopic Remyotomy for Failed Heller Myotomy

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