Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
1 other identifier
interventional
100
1 country
1
Brief Summary
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedDecember 5, 2012
December 1, 2012
8 months
November 20, 2012
December 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedure time in both groups
during POEM procedure
Secondary Outcomes (1)
clinical efficacy and safety
during hospital stay and up to 1 year
Other Outcomes (1)
Therapeutic success
Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year
Study Arms (2)
Water-jet POEM
ACTIVE COMPARATORPOEM were performed by the use of Erbe Hybrid knife (WJ group)
Conventional POEM
ACTIVE COMPARATORPOEM were performed by the conventional technique using injection and triangle tip knife (C group).
Interventions
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.
PMID: 24232052DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ping-Hong Zhou, M.D., PhD
Fudan 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
November 20, 2012
First Posted
December 5, 2012
Study Start
August 1, 2011
Primary Completion
April 1, 2012
Study Completion
December 1, 2012
Last Updated
December 5, 2012
Record last verified: 2012-12