Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
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| ClinicalTrials.gov Identifier: NCT02989818 |
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Recruitment Status :
Recruiting
First Posted : December 12, 2016
Last Update Posted : February 26, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Endoscopic Submucosal Dissection | Other: Endoscopic Submucosal Dissection |
Multi-center prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
All patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated will be considered for the study. Patients in whom ESD is considered as part of their standard medical care will be offered to participate in this study. The physician performing the procedure will also discuss the study with the subjects. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided. If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD will be performed as medically indicated. The investigators from each respective center on this project will also be in charge of the medical care of the patients enrolled in the study. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study.
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population |
| Actual Study Start Date : | March 2016 |
| Estimated Primary Completion Date : | January 2026 |
| Estimated Study Completion Date : | January 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lesion of the Gastrointestinal tract
Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion
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Other: Endoscopic Submucosal Dissection
This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.
Other Name: ESD |
- Rate of en-bloc resection [ Time Frame: 3-4 hours ]An Excision of the targeted lesion in a single specimen
- Rate of R0 resection [ Time Frame: 3-4 hours ]when all vertical and horizontal margins are negative
- Rate of R1 resection [ Time Frame: 3-4 hours ]complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins
- Curative resection [ Time Frame: 3-4 hours ]this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa
- Rate of Adverse events with ESD [ Time Frame: 1 month ]Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
- Rate of complete remission of neoplasia [ Time Frame: 1 month ]Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- a. Age 18 years or older.
- b. Scheduled to undergo ESD as part of their standard of care.
Exclusion Criteria:
- a. Any contraindication to performing endoscopy.
- b. Participation in another research protocol that could interfere or influence the outcome measures of the present study.
- c. Patient is unable/unwilling to provide informed consent.
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): NCT02989818
| Contact: Peter Draganov, MD | 352-273-9472 | peter.draganov@medicine.ufl.edu |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Peter Draganov, MD 352-273-9472 peter.draganov@medicine.ufl.edu | |
| Principal Investigator: Peter Draganov, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Peter Draganov, MD | University of Florida |
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT02989818 |
| Other Study ID Numbers: |
IRB201600246 |
| First Posted: | December 12, 2016 Key Record Dates |
| Last Update Posted: | February 26, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |