Clinical Trials Directory

Trials / Completed

CompletedNCT01753544

Endoscopic Submucosal Dissection Using a Thulium Laser

Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Soonchunhyang University Hospital · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Accepted

Summary

We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.

Detailed description

Instead of endoscopic knives, a thin, flexible fiber is inserted through the working channel of the endoscope. Acetic acid (1.5%) and indigo carmine dye are sprayed onto the lesion to clarify the margin. Markings are made 10 mm outside the tumor margin using a laser fiber with a power setting at 30 W. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine (1:25000) is injected into the submucosa outside the marking dots. A circumferential mucosal incision and submucosal dissection are performed by a thulium laser fiber with a power setting at 30 to 40 W. Activation of the laser beam is controlled by stepping on a foot pedal. Hemostasis during procedure is also attempted using the thulium laser. When hemostasis is not achieved properly, additional use of hemostatic forceps or a hemoclip will be considered.

Conditions

Timeline

Start date
2012-10-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2012-12-20
Last updated
2015-11-17

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01753544. Inclusion in this directory is not an endorsement.