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Endoscopic Submucosal Dissection Using a Thulium Laser

This study has been completed.
Information provided by (Responsible Party):
Jun-Hyung Cho, Soonchunhyang University Hospital Identifier:
First received: December 17, 2012
Last updated: November 16, 2015
Last verified: November 2015
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.

Gastric Dysplasia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia

Resource links provided by NLM:

Further study details as provided by Jun-Hyung Cho, Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Technical success [ Time Frame: 1 day ]
    Curative resection rate

Secondary Outcome Measures:
  • Complication rate [ Time Frame: 7 days ]
    Procedure-related bleeding, perforation

Biospecimen Retention:   Samples Without DNA
ESD specimen will be examined by a experienced pathologist.

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01753544

Korea, Republic of
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-887
Sponsors and Collaborators
Soonchunhyang University Hospital
Principal Investigator: Joo Young Cho, M.D. Digestive Disease Center, Soonchunhyang University Hospital