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Endoscopic Submucosal Dissection Using a Thulium Laser

NCT ID: NCT01753544

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Dysplasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun-Hyung Cho

Clinical and Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo Young Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Center, Soonchunhyang University Hospital

Locations

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Digestive Disease Center, Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 18377234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17566639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17096062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20704034 (View on PubMed)

Other Identifiers

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SCH-ESD-2012

Identifier Type: -

Identifier Source: org_study_id

NCT01838837

Identifier Type: -

Identifier Source: nct_alias