Endoscopic Submucosal Dissection Using a Thulium Laser
- Conditions
- Gastric Dysplasia
- Registration Number
- NCT01753544
- Lead Sponsor
- Soonchunhyang University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- biopsy-proven gastric epithelial neoplasia
- a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Technical success 1 day Curative resection rate
- Secondary Outcome Measures
Name Time Method Complication rate 7 days Procedure-related bleeding, perforation
Trial Locations
- Locations (1)
Digestive Disease Center, Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of