Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study.
William King, Peter Draganov, V Subhash Gorrepati...
https://pubmed.ncbi.nlm.nih.gov/36731578Actively Recruiting
Led by University of Florida · Updated on 2026-04-07
300
Participants Needed
3
Research Sites
N/A
Total Duration
This research aims to document the clinical usefulness of Endoscopic Submucosal Dissection (ESD) in patients from Western populations. The study is observational and involves multiple centers, focusing on patients who are already scheduled to undergo ESD as part of their regular medical care. The goal is to collect data prospectively to better understand the procedure's application in removing gastrointestinal lesions. Participants will receive standard medical care without any experimental treatments. ESD will be performed as medically indicated by their physicians, and the study will record data on the procedure and its outcomes. There are no additional interventions or clinic visits required specifically for the study, and follow-up care will continue as usual. During the study, researchers will collect data on the effectiveness and safety of ESD, including measures like the rate of complete lesion removal and adverse events within one month. The primary outcome is the rate of en-bloc resection, with additional outcomes including curative resection and remission rates. The involvement period varies with each participant's treatment and follow-up schedule, with data collection occurring during and after the procedure as part of standard care.
CONDITIONS
Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure lasting 3 to 4 hours
Participants undergo Endoscopic Submucosal Dissection (ESD) as part of their standard medical care to remove gastrointestinal lesions.
1 visit (in-person)
Duration - Up to 1 month or as medically indicated
Participants are observed during follow-up visits carried out as medically indicated without any additional study-specific visits.
Total: 3 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
P
Peter Draganov, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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William King, Peter Draganov, V Subhash Gorrepati...
https://pubmed.ncbi.nlm.nih.gov/36731578Dennis Yang, William King, Hiroyuki Aihara...
https://pubmed.ncbi.nlm.nih.gov/34906544Peter V Draganov, Hiroyuki Aihara, Michael S Karasik...
https://pubmed.ncbi.nlm.nih.gov/33610532