POEM vs. Pneumatic Dilation for Esophageal Achalasia
Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial
2 other identifiers
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 15, 2013
January 1, 2013
2 years
January 5, 2013
January 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapeutic success
Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
From date of randomization until the follow-up ended, assessed up to 2 years
Secondary Outcomes (4)
Procedure related complication
From date of randomization until the follow-up ended, assessed up to 2 years
Time of treatment failure
From date of randomization until the follow-up ended, assessed up to 2 years
Pressure at the lower esophageal sphincter
From date of randomization until the follow-up ended, assessed up to 2 years
Quality of life
From date of randomization until the follow-up ended, assessed up to 2 years
Study Arms (2)
POEM
EXPERIMENTALPOEM for patients with esophageal achalasia
Pneumatic dilation
ACTIVE COMPARATORPneumatic dilation for patients with esophageal achalasia
Interventions
1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 13 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm. 4. Long endoscopic myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact. The expected end point of myotomy is 2 cm distal to the GEJ. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips. (Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271)
A Rigiflex balloon (30 mm) was positioned at the esophagogastric junction and dilated at a pressure of 5 PSI for 1 minute, followed by 8 PSI for 1 minute. (N Engl J Med 2011;364:1807-16.)
Eligibility Criteria
You may qualify if:
- Between 18 and 75 years of age
- Patient with esophageal achalasia
- Eckardt score \> 3
- Signed informed consent
You may not qualify if:
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus
- Previous endoscopic Botox injection
- Previous oesophageal or gastric surgery
- Pregnancy or lactation women, or ready to pregnant women
- Not capable of filling out questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (2)
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: 20354937BACKGROUNDBoeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
PMID: 21561346BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Gong, M.D.
Department of Gastroenterology, Nanfang Hospital of Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2013
First Posted
January 15, 2013
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 15, 2013
Record last verified: 2013-01