Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia
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ClinicalTrials.gov Identifier: NCT01649843 |
Recruitment Status
: Unknown
Verified July 2012 by Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted
: July 25, 2012
Last Update Posted
: July 25, 2012
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Achalasia | Procedure: POEM | Not Applicable |
- 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).
- 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 450 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
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)).
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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.
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- 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. ]
- Procedure-related adverse events [ Time Frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD. ]
- 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 ]
- 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. ]

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Ages Eligible for Study: | 6 Years to 90 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649843
Contact: Ping-Hong Zhou, MD,PhD | zhou1968@yahoo.cn |
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 |
Study Director: | Ping-Hong Zhou, MD,PhD | Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shanghai Zhongshan Hospital |
ClinicalTrials.gov Identifier: | NCT01649843 History of Changes |
Other Study ID Numbers: |
Endoscopycenter-POEM |
First Posted: | July 25, 2012 Key Record Dates |
Last Update Posted: | July 25, 2012 |
Last Verified: | July 2012 |
Keywords provided by Shanghai Zhongshan Hospital:
Peroral endoscopic myotomy Esophageal Achalasia |
Additional relevant MeSH terms:
Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |