Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

NCT01649843 | Unknown DMC

• 1 other identifier: Endoscopycenter-POEM
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Achalasia

Keywords

Peroral endoscopic myotomy; Esophageal Achalasia

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• Procedure-related adverse events

  All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.

• Lower esophageal sphincter (LES) pressure on manometry

  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

  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.

Study Arms (1)

EA

EXPERIMENTAL

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

Interventions

POEM PROCEDURE

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.

EA

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 21522116 BACKGROUND

• 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.

  PMID: 20354937 RESULT

• 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.

  PMID: 22068665 RESULT

• 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.

  PMID: 22609984 RESULT

• 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.

  PMID: 25492452 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ping-Hong Zhou, MD,PhD

  Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

Ping-Hong Zhou, MD,PhD

CONTACT

zhou1968@yahoo.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

CN (1)