Endoscopic Submucosal Dissection Using a Thulium Laser
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Purpose
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.
| Condition |
|---|
|
Gastric Dysplasia |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
All patients are diagnosed with gastric epithelial neoplasia in a private clinic and referred to our hospital for endoscopic resection.
Inclusion Criteria:
- biopsy-proven gastric epithelial neoplasia
Exclusion Criteria:
- a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm
Contacts and Locations| Contact: Jun-Hyung Cho, M.D. | +82-2-709-9202 | chojhmd@naver.com |
| Korea, Republic of | |
| Digestive Disease Center, Soonchunhyang University Hospital | Recruiting |
| Seoul, Korea, Republic of, 140-887 | |
| Digestive Disease Center, Soonchunhyang University Hospital | Recruiting |
| Seoul, Korea, Republic of, 140-887 | |
| Contact: Jun-Hyung Cho, M.D. +82-2-709-9202 chojhmd@naver.com | |
| Principal Investigator: | Joo Young Cho, M.D. | Digestive Disease Center, Soonchunhyang University Hospital |
More Information
Publications:
| Responsible Party: | Jun-Hyung Cho, Clinical and Research Fellow, Soonchunhyang University Hospital |
| ClinicalTrials.gov Identifier: | NCT01753544 History of Changes |
| Other Study ID Numbers: | SCH-ESD-2012 |
| Study First Received: | December 17, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Korea: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013