Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01649843
First received: July 12, 2012
Last updated: July 22, 2012
Last verified: July 2012
  Purpose

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.


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: Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

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 during follow-up, an expected average of 2 years. ] [ 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 during follow-up, an expected average of 2 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: August 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: EA
Patients were eligible for enrollment in the study if they had 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)).
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 in some centers.

Detailed Description:
  1. Patients were eligible for enrollment in the study if they had 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:   6 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Informed patient consent was obtained

Exclusion Criteria:

  • Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
  • Pseudoachalasia
  • megaesophagus (diameter of > 7 cm)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649843

Contacts
Contact: Ping-Hong Zhou, MD,PhD 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       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: NCT01649843     History of Changes
Other Study ID Numbers: Endoscopycenter-POEM
Study First Received: July 12, 2012
Last Updated: July 22, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Zhongshan Hospital:
Peroral endoscopic myotomy
Esophageal Achalasia

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

ClinicalTrials.gov processed this record on November 23, 2014