Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

• Conditions: Endoscopy, Digestive System; Esophageal Neoplasms; Stomach Neoplasms

• Registration Number: NCT01185483
• Lead Sponsor: Odense University Hospital

Brief Summary

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2010-08
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-06
• Primary Completion: 2010-11
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Submucosal tumor (< 4 cm)
• Mucosal tumor (T1) in patients unsuitable for surgery

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Exclusion Criteria

• Endoscopic ultrasound (EUS) or CT signs of metastasis
• Insufficient access to tumor

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark