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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760070
• Other study ID #: XIJINGHDD-20121227-01
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Dysplasia
• Esophageal Neoplasms
• Stomach Cancer
• Stomach Dysplasia
• Stomach Neoplasms

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