Endoscopic Submucosal Dissection Using a Thulium Laser
1 other identifier
observational
10
1 country
1
Brief Summary
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 17, 2015
November 1, 2015
11 months
December 17, 2012
November 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Technical success
Curative resection rate
1 day
Secondary Outcomes (1)
Complication rate
7 days
Eligibility Criteria
All patients are diagnosed with gastric epithelial neoplasia in a private clinic and referred to our hospital for endoscopic resection.
You may qualify if:
- biopsy-proven gastric epithelial neoplasia
You may not qualify if:
- a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, 140-887, South Korea
Related Publications (4)
Wendt-Nordahl G, Huckele S, Honeck P, Alken P, Knoll T, Michel MS, Hacker A. Systematic evaluation of a recently introduced 2-microm continuous-wave thulium laser for vaporesection of the prostate. J Endourol. 2008 May;22(5):1041-5. doi: 10.1089/end.2007.0421.
PMID: 18377234BACKGROUNDXia SJ, Zhuo J, Sun XW, Han BM, Shao Y, Zhang YN. Thulium laser versus standard transurethral resection of the prostate: a randomized prospective trial. Eur Urol. 2008 Feb;53(2):382-89. doi: 10.1016/j.eururo.2007.05.019. Epub 2007 Jun 4.
PMID: 17566639BACKGROUNDGotoda T, Yamamoto H, Soetikno RM. Endoscopic submucosal dissection of early gastric cancer. J Gastroenterol. 2006 Oct;41(10):929-42. doi: 10.1007/s00535-006-1954-3. Epub 2006 Nov 9.
PMID: 17096062BACKGROUNDDray X, Donatelli G, Krishnamurty DM, Dubcenco E, Wroblewski RJ, Assumpcao L, Giday SA, Buscaglia JM, Shin EJ, Magno P, Pipitone LJ, Marohn MR, Kantsevoy SV, Kalloo AN. A 2-microm continuous-wave laser system for safe and high-precision dissection during NOTES procedures. Dig Dis Sci. 2010 Sep;55(9):2463-70. doi: 10.1007/s10620-010-1214-5.
PMID: 20704034BACKGROUND
Biospecimen
ESD specimen will be examined by a experienced pathologist.
Study Officials
- PRINCIPAL INVESTIGATOR
Joo Young Cho, M.D.
Digestive Disease Center, Soonchunhyang University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical and Research Fellow
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 20, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
November 17, 2015
Record last verified: 2015-11