Endoscopic Submucosal Dissection Using a Thulium Laser
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia|
- Technical success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]Curative resection rate
- Complication rate [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Procedure-related bleeding, perforation
Biospecimen Retention: Samples Without DNA
ESD specimen will be examined by a experienced pathologist.
|Study Start Date:||October 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753544
|Korea, Republic of|
|Digestive Disease Center, Soonchunhyang University Hospital|
|Seoul, Korea, Republic of, 140-887|
|Principal Investigator:||Joo Young Cho, M.D.||Digestive Disease Center, Soonchunhyang University Hospital|