Clinical trial NCT02989818: Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
Official title: Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopic Submucosal Dissection
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of en-bloc resection
timeFrame: 3-4 hours
Secondary outcomes:
measure: Rate of R0 resection
timeFrame: 3-4 hours
measure: Rate of R1 resection
timeFrame: 3-4 hours
measure: Curative resection
timeFrame: 3-4 hours
measure: Rate of Adverse events with ESD
timeFrame: 1 month
measure: Rate of complete remission of neoplasia
timeFrame: 1 month
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang 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.
citation: Draganov 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.