Comparison of O-type Hybrid Knife and IT Knife in ESD

Not Applicable

Completed

• Conditions: Stomach Cancer; Stomach Dysplasia; Esophageal Dysplasia; Esophageal Cancer
• Interventions: Device: Hybrid knife; Device: IT knife

• Registration Number: NCT01760070
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.

Detailed Description

Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-28
• Study First Submitted QC: 2012-12-28
• Study First Posted: 2013-01-03
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
• The patients who agreed informed consent

Exclusion Criteria

• Recent drug history of anticoagulant or antiplatelet agent within 7 days
• Recurrent gastric or esophageal adenoma or early cancer
• Pregnant or breast feeding patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid knife	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.
IT knife	IT knife	IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.

Primary Outcome Measures

Name	Time	Method
Procedure time for ESD	up to 1 day	The time to finish the whole ESD procedure.

Secondary Outcome Measures

Name	Time	Method
Submucosal dissection time	up to 1 day	The time for submucosal dissection of ESD
Perforation rate	up to 7 day	The perforation rate of ESD during and after procedure.
Bleeding Rate	up to 7 days	The bleeding rate of ESD during and after procedure.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China