Endoscopic Submucosal Dissection Using a Thulium Laser
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| First Received Date ICMJE | December 17, 2012 | ||||
| Last Updated Date | December 20, 2012 | ||||
| Start Date ICMJE | October 2012 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Technical success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ] Curative resection rate |
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| Original Primary Outcome Measures ICMJE |
Technical success and complication rate [ Time Frame: December 1, 2012 ] [ Designated as safety issue: Yes ] Technical success: curative resection rate, Complication rate: procedure-related bleeding, perforation |
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| Change History | Complete list of historical versions of study NCT01753544 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Complication rate [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] Procedure-related bleeding, perforation |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endoscopic Submucosal Dissection Using a Thulium Laser | ||||
| Official Title ICMJE | Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia | ||||
| Brief Summary | We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: ESD specimen will be examined by a experienced pathologist. |
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| 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. |
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| Condition ICMJE | Gastric Dysplasia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01753544 | ||||
| Other Study ID Numbers ICMJE | SCH-ESD-2012 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jun-Hyung Cho, Soonchunhyang University Hospital | ||||
| Study Sponsor ICMJE | Soonchunhyang University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Soonchunhyang University Hospital | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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