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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer, Stomach Dysplasia

Intervention / Treatment
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* Device: Hybrid knife
* Device: IT knife


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid knife<br>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<br>* Use Hybrid knife in ESD procedure<br>|
| Active Comparator: IT knife<br>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<br>* Use IT knife in ESD procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time for ESD | The time to finish the whole ESD procedure. | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Submucosal dissection time | The time for submucosal dissection of ESD | up to 1 day | 
| Perforation rate | The perforation rate of ESD during and after procedure. | up to 7 day | 
| Bleeding Rate | The bleeding rate of ESD during and after procedure. | up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, endoscopy, endoscopic submucosal dissection