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Completed

NCT Number: NCT01760070

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

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Dysplasia Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Cancer Stomach Diseases Stomach Dysplasia Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid knife

Device

Use Hybrid knife in ESD procedure

IT knife

Device

Use IT knife in ESD procedure.

Primary outcomes

  1. Procedure time for ESD

    Time frame: up to 1 day

    The time to finish the whole ESD procedure.

Secondary outcomes

  1. Submucosal dissection time

    Time frame: up to 1 day

    The time for submucosal dissection of ESD

  2. Perforation rate

    Time frame: up to 7 day

    The perforation rate of ESD during and after procedure.

  3. Bleeding Rate

    Time frame: up to 7 days

    The bleeding rate of ESD during and after procedure.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2013
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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