Endoscopic Submucosal Dissection Using a Thulium Laser

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Soonchunhyang University Hospital
Sponsor:
Information provided by (Responsible Party):
Jun-Hyung Cho, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01753544
First received: December 17, 2012
Last updated: December 20, 2012
Last verified: December 2012

December 17, 2012
December 20, 2012
October 2012
September 2013   (final data collection date for primary outcome measure)
Technical success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Curative resection rate
Technical success and complication rate [ Time Frame: December 1, 2012 ] [ Designated as safety issue: Yes ]
Technical success: curative resection rate, Complication rate: procedure-related bleeding, perforation
Complete list of historical versions of study NCT01753544 on ClinicalTrials.gov Archive Site
Complication rate [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Procedure-related bleeding, perforation
Not Provided
Not Provided
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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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

ESD specimen will be examined by a experienced pathologist.

Non-Probability Sample

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

Gastric Dysplasia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
Yes
Contact: Jun-Hyung Cho, M.D. +82-2-709-9202 chojhmd@naver.com
Korea, Republic of
 
NCT01753544
SCH-ESD-2012
Yes
Jun-Hyung Cho, Soonchunhyang University Hospital
Soonchunhyang University Hospital
Not Provided
Principal Investigator: Joo Young Cho, M.D. Digestive Disease Center, Soonchunhyang University Hospital
Soonchunhyang University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP