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

January 22, 2015 updated by: Zhiguo Liu, Xijing Hospital of Digestive Diseases

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Principal Investigator: Zhiguo Liu, Xijing Hospital of Digestive Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XIJINGHDD-20121227-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Cancer

Clinical Trials on Hybrid knife

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe