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

NCT ID: NCT01760070

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Esophageal Cancer; Esophageal Dysplasia; Stomach Cancer; Stomach Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hybrid knife

Intervention Type: DEVICE

Use Hybrid knife in ESD procedure

IT knife

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

Group Type: ACTIVE_COMPARATOR

IT knife

Intervention Type: DEVICE

Use IT knife in ESD procedure.

Interventions

Hybrid knife

Use Hybrid knife in ESD procedure

Intervention Type: DEVICE

IT knife

Use IT knife in ESD procedure.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguo Liu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases

Locations

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 19343433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21316668 (View on PubMed)

Other Identifiers

XIJINGHDD-20121227-01

Identifier Type: -

Identifier Source: org_study_id