Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
|ClinicalTrials.gov Identifier: NCT01742494|
Recruitment Status : Unknown
Verified December 2012 by Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: Water-jet POEM Procedure: Conventional POEM||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||December 2012|
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.
- Procedure time in both groups [ Time Frame: during POEM procedure ]
- clinical efficacy and safety [ Time Frame: during hospital stay and up to 1 year ]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 ]a reduction in the Eckardt score to ≤3
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742494
|Contact: Ping-Hong Zhou, M.D, PhDfirstname.lastname@example.org|
|Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator: Ping-Hong Zhou, MD,PhD|
|Study Director:||Ping-Hong Zhou, M.D., PhD||Fudan University|