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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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer, Stomach Dysplasia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Procedure time for ESD

Outcome Description:

The time to finish the whole ESD procedure.

Outcome Time Frame:

up to 1 day

Safety Issue:

No

Principal Investigator

Zhiguo Liu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Xijing Hospital of Digestive Diseases

Authority:

China: Ministry of Health

Study ID:

XIJINGHDD-20121227-01

NCT ID:

NCT01760070

Start Date:

December 2012

Completion Date:

March 2013

Related Keywords:

  • Esophageal Cancer
  • Esophageal Dysplasia
  • Stomach Cancer
  • Stomach Dysplasia
  • cancer
  • endoscopy
  • endoscopic submucosal dissection
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Stomach Neoplasms
  • Hyperplasia

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