Comparison of O-type Hybrid Knife and IT Knife in ESD
|ClinicalTrials.gov Identifier: NCT01760070|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Esophageal Dysplasia Stomach Cancer Stomach Dysplasia||Device: Hybrid knife Device: IT knife|
|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|
|Primary Completion Date :||October 2014|
|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.
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|