NCT05468008

Brief Summary

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2022Dec 2027

Study Start

First participant enrolled

February 4, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

February 23, 2022

Last Update Submit

January 29, 2026

Conditions

Esophageal LesionBarrett EsophagusGastrointestinal Lesions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the utility of ESD for treatment of gastrointestinal lesions

    The primary endpoint of this study will be the prospective evaluation of the utility of ESD for the endoscopic treatment of GI lesions.

    12 months

Secondary Outcomes (4)

  • En-Bloc Resection Rate

    6 months

  • Complete Resection Rate

    6 months

  • Curative Resection Rate

    6 months

  • Safety- Adverse Events

    12 months

Interventions

Endoscopic Submucosal DissectionPROCEDURE

Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the Center of Interventional Endoscopy for standard of care ESD procedure.

You may qualify if:

  • Age 18 years or older
  • Scheduled to undergo ESD

You may not qualify if:

  • Any contraindication to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Related Publications (6)

  • Kotzev AI, Yang D, Draganov PV. How to master endoscopic submucosal dissection in the USA. Dig Endosc. 2019 Jan;31(1):94-100. doi: 10.1111/den.13240. Epub 2018 Aug 22.

    PMID: 30022521BACKGROUND

  • Yang D, Wagh MS, Draganov PV. The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging. Gastrointest Endosc. 2020 Nov;92(5):1016-1025. doi: 10.1016/j.gie.2020.05.047. Epub 2020 Jun 3.

    PMID: 32504699BACKGROUND

  • Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111/den.12456. Epub 2015 Mar 5.

    PMID: 25652022BACKGROUND

  • Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26.

    PMID: 30267866BACKGROUND

  • Yang D, Draganov PV. Expanding Role of Third Space Endoscopy in the Management of Esophageal Diseases. Curr Treat Options Gastroenterol. 2018 Mar;16(1):41-57. doi: 10.1007/s11938-018-0169-z.

    PMID: 29435819BACKGROUND

  • Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016/j.gie.2017.02.024. Epub 2017 Feb 28.

    PMID: 28254526BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dennis Yang, MD

    AdventHealth Orlando

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Yang, MD

CONTACT

407-303-2570Dennis.Yang.MD@adventhealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

July 21, 2022

Study Start

February 4, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)