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

Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01760070

Enrollment

Registered

2013-01-03

Start date

2012-12-31

Completion date

2014-12-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer, Stomach Dysplasia

Keywords

cancer, endoscopy, endoscopic submucosal dissection

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.

Interventions

DEVICEHybrid knife

Use Hybrid knife in ESD procedure

DEVICEIT knife

Use IT knife in ESD procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Procedure time for ESD	up to 1 day	The time to finish the whole ESD procedure.

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026