Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01185483
First received: August 17, 2010
Last updated: September 3, 2010
Last verified: August 2010

August 17, 2010
September 3, 2010
November 2009
November 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01185483 on ClinicalTrials.gov Archive Site
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Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients referred to the Endoscopic Section at the Department of Surgery, Odense University Hospital, with a mucosal or submucosal tumor in the esophagus or stomach.

  • Endoscopy, Digestive System
  • Esophageal Neoplasms
  • Stomach Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Michael H. Larsen, M.D. 0045 29694631 mhl@dadlnet.dk
Denmark
 
NCT01185483
ESD-HYBRID-AFDA
No
Michael Bau Mortensen, Odense University Hospital
Odense University Hospital
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Odense University Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP