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

Primary Purpose

Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hybrid knife
IT knife
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring cancer, endoscopy, endoscopic submucosal dissection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid knife

IT knife

Arm 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.

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

Outcomes

Primary Outcome Measures

Procedure time for ESD
The time to finish the whole ESD procedure.

Secondary Outcome Measures

Submucosal dissection time
The time for submucosal dissection of ESD
Perforation rate
The perforation rate of ESD during and after procedure.
Bleeding Rate
The bleeding rate of ESD during and after procedure.

Full Information

First Posted
December 28, 2012
Last Updated
January 22, 2015
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT01760070
Brief Title
Comparison of O-type Hybrid Knife and IT Knife in ESD
Official Title
Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer, Stomach Dysplasia
Keywords
cancer, endoscopy, endoscopic submucosal dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid knife
Arm Type
Experimental
Arm 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.
Arm Title
IT knife
Arm Type
Active Comparator
Arm Description
IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Intervention Type
Device
Intervention Name(s)
Hybrid knife
Intervention Description
Use Hybrid knife in ESD procedure
Intervention Type
Device
Intervention Name(s)
IT knife
Intervention Description
Use IT knife in ESD procedure.
Primary Outcome Measure Information:
Title
Procedure time for ESD
Description
The time to finish the whole ESD procedure.
Time Frame
up to 1 day
Secondary Outcome Measure Information:
Title
Submucosal dissection time
Description
The time for submucosal dissection of ESD
Time Frame
up to 1 day
Title
Perforation rate
Description
The perforation rate of ESD during and after procedure.
Time Frame
up to 7 day
Title
Bleeding Rate
Description
The bleeding rate of ESD during and after procedure.
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiguo Liu
Organizational Affiliation
Xijing Hospital of Digestive Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19343433
Citation
Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.
Results Reference
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PubMed Identifier
21316668
Citation
Fukami N, Ryu CB, Said S, Weber Z, Chen YK. Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study. Gastrointest Endosc. 2011 Jun;73(6):1246-53. doi: 10.1016/j.gie.2010.12.004. Epub 2011 Feb 12.
Results Reference
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Comparison of O-type Hybrid Knife and IT Knife in ESD

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