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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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