Endoscopic Submucosal Dissection Using a Thulium Laser

NCT01753544 — Completed, 10 participants, Soonchunhyang University Hospital

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

Registry	NCT01753544
Status	Completed
Study type	Observational
Enrollment	10 (Actual)
Sponsor	Soonchunhyang University Hospital (Other)
Conditions	Gastric Dysplasia
Dates	start 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 in South Korea

-Summary

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

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+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.

+Outcome measures

Primary outcomes

Technical success [1 day]: Curative resection rate

Secondary outcomes

Complication rate [7 days]: Procedure-related bleeding, perforation

+Eligibility

Sex: All, ages: 20 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Digestive Disease Center, Soonchunhyang University Hospital	Seoul	South Korea

+Publications

Wendt-Nordahl G, Huckele S, Honeck P, Alken P, Knoll T, Michel MS, Hacker A. Systematic evaluation of a recently introduced 2-microm continuous-wave thulium laser for vaporesection of the prostate. J Endourol. 2008 May;22(5):1041-5. doi: 10.1089/end.2007.0421. PMID 18377234
Xia SJ, Zhuo J, Sun XW, Han BM, Shao Y, Zhang YN. Thulium laser versus standard transurethral resection of the prostate: a randomized prospective trial. Eur Urol. 2008 Feb;53(2):382-89. doi: 10.1016/j.eururo.2007.05.019. Epub 2007 Jun 4. PMID 17566639
Gotoda T, Yamamoto H, Soetikno RM. Endoscopic submucosal dissection of early gastric cancer. J Gastroenterol. 2006 Oct;41(10):929-42. doi: 10.1007/s00535-006-1954-3. Epub 2006 Nov 9. PMID 17096062
Dray X, Donatelli G, Krishnamurty DM, Dubcenco E, Wroblewski RJ, Assumpcao L, Giday SA, Buscaglia JM, Shin EJ, Magno P, Pipitone LJ, Marohn MR, Kantsevoy SV, Kalloo AN. A 2-microm continuous-wave laser system for safe and high-precision dissection during NOTES procedures. Dig Dis Sci. 2010 Sep;55(9):2463-70. doi: 10.1007/s10620-010-1214-5. PMID 20704034

+Investigators

Joo Young Cho, M.D., Principal investigator, Digestive Disease Center, Soonchunhyang University Hospital