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

Xijing Hospital of Digestive Diseases

Status: Completed

Conditions: Esophageal Cancer; Stomach Dysplasia; Esophageal Dysplasia; Stomach Cancer

Treatments: Device: Hybrid knife; Device: IT knife

Study type: Interventional

Funder types: Other

Identifiers

NCT01760070

XIJINGHDD-20121227-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Hybrid knife

Experimental group

Description:

O-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.

Treatment:

Device: Hybrid knife

IT knife

Active Comparator group

Description:

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

Treatment:

Device: IT knife