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Endoscopic Submucosal Dissection Using a Thulium Laser

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753544
First Posted: December 20, 2012
Last Update Posted: November 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun-Hyung Cho, Soonchunhyang University Hospital
  Purpose
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.

Condition
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.
  Eligibility

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753544


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