Peroral Endoscopic Remyotomy for Failed Heller Myotomy

This study is currently recruiting participants.
Verified May 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01637311
First received: July 3, 2012
Last updated: July 6, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Esophageal Achalasia
Procedure: POEM

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procedure-related adverse events [ Time Frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Failed HM
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
Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637311

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

Locations
China
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Ping-Hong Zhou, MD,PhD    (+86)-21-64041990    zhou1968@yahoo.cn   
Principal Investigator: Ping-Hong Zhou, MD,PhD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Director: Ping-Hong Zhou, MD,PhD Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China
  More Information

Publications:

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01637311     History of Changes
Other Study ID Numbers: ZSNJ-POEM
Study First Received: July 3, 2012
Last Updated: July 6, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Zhongshan Hospital:
Peroral endoscopic myotomy
Heller myotomy
persistent/recurrent achalasia.

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 14, 2014