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

This study is currently recruiting participants.
Verified December 2012 by Xijing Hospital of Digestive Diseases
Sponsor:
Information provided by (Responsible Party):
Zhiguo Liu, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT01760070
First received: December 28, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention
Esophageal Cancer
Esophageal Dysplasia
Stomach Cancer
Stomach Dysplasia
 Device: Hybrid knife
Device: IT knife

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital of Digestive Diseases:

Primary Outcome Measures:
  • Procedure time for ESD [ Time Frame: up to 1 day ] [ Designated as safety issue: No ]
    The time to finish the whole ESD procedure.


Secondary Outcome Measures:
  • Submucosal dissection time [ Time Frame: up to 1 day ] [ Designated as safety issue: No ]
    The time for submucosal dissection of ESD

  • Perforation rate [ Time Frame: up to 7 day ] [ Designated as safety issue: Yes ]
    The perforation rate of ESD during and after procedure.

  • Bleeding Rate [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
    The bleeding rate of ESD during and after procedure.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760070

Contacts
Contact: zhiguo liu, Ph.D. 86-29-84771536 liuzhiguo@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Zhiguo Liu     86-29-84771536        
Principal Investigator: zhiguo liu            
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
Principal Investigator: Zhiguo Liu Xijing Hospital of Digestive Diseases
  More Information

Publications:

Responsible Party: Zhiguo Liu, Associate Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT01760070     History of Changes
Other Study ID Numbers: XIJINGHDD-20121227-01
Study First Received: December 28, 2012
Last Updated: December 28, 2012
Health Authority: China: Ministry of Health

Keywords provided by Xijing Hospital of Digestive Diseases:
cancer
endoscopy
endoscopic submucosal dissection

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Stomach Neoplasms
Hyperplasia
Gastrointestinal Diseases
 Digestive System Diseases
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013