Comparison of O-type Hybrid Knife and IT Knife in ESD
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|ClinicalTrials.gov Identifier: NCT01760070|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Esophageal Dysplasia Stomach Cancer Stomach Dysplasia||Device: Hybrid knife Device: IT knife||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Hybrid knife
O-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Device: Hybrid knife
Use Hybrid knife in ESD procedure
Active Comparator: IT knife
IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Device: IT knife
Use IT knife in ESD procedure.
- Procedure time for ESD [ Time Frame: up to 1 day ]The time to finish the whole ESD procedure.
- Submucosal dissection time [ Time Frame: up to 1 day ]The time for submucosal dissection of ESD
- Perforation rate [ Time Frame: up to 7 day ]The perforation rate of ESD during and after procedure.
- Bleeding Rate [ Time Frame: up to 7 days ]The bleeding rate of ESD during and after procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760070
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Zhiguo Liu||Xijing Hospital of Digestive Diseases|