Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Esophageal Achalasia	Procedure: POEM	Not Applicable

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.

Study Design

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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

Arms and Interventions

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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)).	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.

Outcome Measures

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Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. Procedure-related adverse events [ Time Frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD. ]
2. 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 ]
3. 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. ]

Eligibility Criteria

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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

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch 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.

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.

Other Publications:

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hu JW, Li QL, Zhou PH, Yao LQ, Xu MD, Zhang YQ, Zhong YS, Chen WF, Ma LL, Qin WZ, Cai MY. Peroral endoscopic myotomy for advanced achalasia with sigmoid-shaped esophagus: long-term outcomes from a prospective, single-center study. Surg Endosc. 2015 Sep;29(9):2841-50. doi: 10.1007/s00464-014-4013-9. Epub 2014 Dec 10.

Responsible Party:	Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:	NCT01649843 History of Changes
Other Study ID Numbers:	Endoscopycenter-POEM
First Posted:	July 25, 2012
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