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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01760070
Other study ID # XIJINGHDD-20121227-01
Secondary ID
Status Completed
Phase N/A
First received December 28, 2012
Last updated January 22, 2015
Start date December 2012
Est. completion date December 2014

Study information

Verified date January 2015
Source Xijing Hospital of Digestive Diseases
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

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


Intervention

Device:
Hybrid knife
Use Hybrid knife in ESD procedure
IT knife
Use IT knife in ESD procedure.

Locations

Country Name City State
China Xijing Hospital of Digestive Diseases Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure time for ESD The time to finish the whole ESD procedure. up to 1 day No
Secondary Submucosal dissection time The time for submucosal dissection of ESD up to 1 day No
Secondary Perforation rate The perforation rate of ESD during and after procedure. up to 7 day Yes
Secondary Bleeding Rate The bleeding rate of ESD during and after procedure. up to 7 days Yes
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