Endoscopic Submucosal DissectionNCT02989818
Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
An observational study of Endoscopic Submucosal Dissection, run by University of Florida at 3 sites in United States.
Trial summary
The aim of this multi-center study is to prospectively document the clinical utility of ESD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endoscopic Submucosal Dissection
- What is being tested?
- Endoscopic Submucosal Dissection
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated and part of their standard of care
Who may be able to join
- a. Age 18 years or older.
- b. Scheduled to undergo ESD as part of their standard of care.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of Florida
Gainesville, Florida, 32610
Peter Draganov, MD, 352-273-9472, peter.draganov@medicine.ufl.edu
Peter Draganov, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population
The aim of this multi-center study is to prospectively document the clinical utility of ESD.
Read the detailed description
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.
- Conditions
- Endoscopic Submucosal Dissection
- Being tested
- Endoscopic Submucosal Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionOther
Also called ESD
This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Endoscopic Submucosal Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of en-bloc resection
An Excision of the targeted lesion in a single specimen
Measured: 3-4 hours
Secondary outcomes (5)
Rate of R0 resection
when all vertical and horizontal margins are negative
Measured: 3-4 hours
Rate of R1 resection
complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins
Measured: 3-4 hours
Curative resection
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
Measured: 3-4 hours
Rate of Adverse events with ESD
Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
Measured: 1 month
Rate of complete remission of neoplasia
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Submucosal DissectionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989818
- Sponsor's protocol ID
- IRB201600246
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2016
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
King W, Draganov P, Gorrepati VS, Hayat M, Aihara H, Karasik M, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Yang D. Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study. Gastrointest Endosc. 2023 Jun;97(6):1045-1051. doi: 10.1016/j.gie.2023.01.042. Epub 2023 Jan 30.
PubMed 36731578Yang D, King W, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Perbtani YB, Hoffman BJ, Akki AS, Schlachterman A, Coman RM, Wang AY, Draganov PV. Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia. Gastrointest Endosc. 2022 Apr;95(4):626-633. doi: 10.1016/j.gie.2021.11.046. Epub 2021 Dec 11.
PubMed 34906544Draganov PV, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Westerveld D, Perbtani YB, Hoffman BJ, Schlachterman A, Siegel A, Coman RM, Wang AY, Yang D. Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study. Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.
PubMed 33610532
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population
- ClinicalTrials.gov ID
- NCT02989818
- Acronym / sponsor ID
- IRB201600246
- Conditions
- Endoscopic Submucosal Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this multi-center study is to prospectively document the clinical utility of ESD.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lesion of the Gastrointestinal tract | – | Other: Endoscopic Submucosal DissectionInvestigator 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated and part of their standard of care
Key inclusion criteria (2 listed)
- a. Age 18 years or older.
- b. Scheduled to undergo ESD as part of their standard of care.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Submucosal DissectionAlso: ESDThis intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion. | Other | Lesion of the Gastrointestinal tract |
Primary outcome
Rate of en-bloc resection
Time frame: 3-4 hours
An Excision of the targeted lesion in a single specimen
5 secondary outcomes
Rate of R0 resection
Time frame: 3-4 hours
Rate of R1 resection
Time frame: 3-4 hours
Curative resection
Time frame: 3-4 hours
Rate of Adverse events with ESD
Time frame: 1 month
Rate of complete remission of neoplasia
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 36731578King W, Draganov P, Gorrepati VS, Hayat M, Aihara H, Karasik M, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Yang D. Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study. Gastrointest Endosc. 2023 Jun;97(6):1045-1051. doi: 10.1016/j.gie.2023.01.042. Epub 2023 Jan 30.
- Derived from this study: PubMed 34906544Yang D, King W, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Perbtani YB, Hoffman BJ, Akki AS, Schlachterman A, Coman RM, Wang AY, Draganov PV. Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia. Gastrointest Endosc. 2022 Apr;95(4):626-633. doi: 10.1016/j.gie.2021.11.046. Epub 2021 Dec 11.
- Derived from this study: PubMed 33610532Draganov PV, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Westerveld D, Perbtani YB, Hoffman BJ, Schlachterman A, Siegel A, Coman RM, Wang AY, Yang D. Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study. Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Draganov, MD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Submucosal Dissection, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Draganov, MD (352-273-9472, peter.draganov@medicine.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of en-bloc resection (time frame: 3-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989818, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.