Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
NCT ID: NCT01742494
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Water-jet POEM
POEM were performed by the use of Erbe Hybrid knife (WJ group)
Water-jet POEM
Water-jet assisted POEM procedure was performed
Conventional POEM
POEM were performed by the conventional technique using injection and triangle tip knife (C group).
Conventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Water-jet POEM
Water-jet assisted POEM procedure was performed
Conventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pseudoachalasia
* Megaesophagus (diameter of \> 7 cm)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Zhongshan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ping-Hong Zhou, M.D., PhD
Role: STUDY_DIRECTOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Hybrid POEM
Identifier Type: -
Identifier Source: org_study_id