Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique|
- Procedure time in both groups [ Time Frame: during POEM procedure ] [ Designated as safety issue: Yes ]
- clinical efficacy and safety [ Time Frame: during hospital stay and up to 1 year ] [ Designated as safety issue: Yes ]bleeding complications, pneumothorax or pleural effusion requiring intervention
- Therapeutic success [ Time Frame: Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year ] [ Designated as safety issue: Yes ]a reduction in the Eckardt score to ≤3
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Water-jet POEM
POEM were performed by the use of Erbe Hybrid knife (WJ group)
Procedure: Water-jet POEM
Water-jet assisted POEM procedure was performed
Active Comparator: Conventional POEM
POEM were performed by the conventional technique using injection and triangle tip knife (C group).
Procedure: Conventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742494
|Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University|
|Shanghai, Shanghai, China, 200032|
|Study Director:||Ping-Hong Zhou, M.D., PhD||Fudan University|