Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01185483

Enrollment

Registered

2010-08-20

Start date

2009-11-30

Completion date

2011-02-28

Last updated

2010-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Digestive System, Esophageal Neoplasms, Stomach Neoplasms

Keywords

Endoscopic submucosal dissection, Submucosal tumor, Minimal invasive, Gastroscopy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Countries

Denmark

Contacts

Primary ContactMichael H. Larsen, M.D.

mhl@dadlnet.dk0045 29694631

Outcome results