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

X

Xijing Hospital of Digestive Diseases

Status

Completed

Conditions

Esophageal Cancer
Stomach Dysplasia
Esophageal Dysplasia
Stomach Cancer

Treatments

Device: Hybrid knife
Device: IT knife

Study type

Interventional

Funder types

Other

Identifiers

NCT01760070
XIJINGHDD-20121227-01

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 2 patient groups

Hybrid knife
Experimental group
Description:
O-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Treatment:
Device: Hybrid knife
IT knife
Active Comparator group
Description:
IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Treatment:
Device: IT knife

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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