Stomach Neoplasms Clinical Trial
Official title:
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
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