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

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

Study Overview

• Status: Completed
• Conditions: Gastric Dysplasia

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 140-887
    • Digestive Disease Center, Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients are diagnosed with gastric epithelial neoplasia in a private clinic and referred to our hospital for endoscopic resection.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Curative resection rate	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Procedure-related bleeding, perforation	7 days

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Joo Young Cho, M.D., Digestive Disease Center, Soonchunhyang University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SCH-ESD-2012