Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
Conditions
Endoscopy, Digestive System - Esophageal Neoplasms - Stomach Neoplasms
Conditions: official terms
Esophageal Neoplasms - Neoplasms - Stomach Neoplasms
Conditions: Keywords
Endoscopic submucosal dissection, Submucosal tumor, Minimal invasive, Gastroscopy
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Submucosal tumor (< 4 cm)

- Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

- Endoscopic ultrasound (EUS) or CT signs of metastasis

- Insufficient access to tumor
Location
Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Michael H Larsen, M.D. - 0045 29694631 - mhl@dadlnet.dk
Start Date
November 2009
Completion Date
February 2011
Sponsors
Odense University Hospital
Source
Odense University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page