Endoscopic Submucosal Dissection Using a Thulium Laser

This study is currently recruiting participants.
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
  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 Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Technical success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Curative resection rate


Secondary Outcome Measures:
  • Complication rate [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Procedure-related bleeding, perforation


Biospecimen Retention:   Samples Without DNA

ESD specimen will be examined by a experienced pathologist.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated 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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753544

Contacts
Contact: Jun-Hyung Cho, M.D. +82-2-709-9202 chojhmd@naver.com

Locations
Korea, Republic of
Digestive Disease Center, Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of, 140-887
Digestive Disease Center, Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of, 140-887
Contact: Jun-Hyung Cho, M.D.    +82-2-709-9202    chojhmd@naver.com   
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Joo Young Cho, M.D. Digestive Disease Center, Soonchunhyang University Hospital