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Endoscopic Submucosal Dissection Using a Thulium Laser

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ClinicalTrials.gov Identifier: NCT01753544
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):

December 17, 2012
December 20, 2012
November 17, 2015
October 2012
September 2013   (Final data collection date for primary outcome measure)
Technical success [ Time Frame: 1 day ]
Curative resection rate
Technical success and complication rate [ Time Frame: December 1, 2012 ]
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 ]
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.
 
Completed
10
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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01753544
SCH-ESD-2012
Yes
Not Provided
Not Provided
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
November 2015