Actively Recruiting

Age: 18Years +
All Genders
ID05468008

Prospective Evaluation of Endoscopic Submucosal Dissection (ESD) for Gastrointestinal Lesions in Western Patients

Led by AdventHealth · Updated on 2026-02-02

1000

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Endoscopic Submucosal Dissection (ESD) to treat gastrointestinal lesions in a Western population. This observational study aims to record procedural and clinical outcomes of ESD performed during routine medical care, without experimental interventions. The study addresses differences in patient populations and lesion locations compared to Asian countries where ESD is more common, especially for early gastric cancer. ESD is a newer outpatient procedure that removes deep tumors from the gastrointestinal tract in one piece, allowing detailed analysis of the lesion and reducing recurrence compared to Endoscopic Mucosal Resection (EMR). This registry collects prospective data on patients undergoing ESD, who will continue to receive standard medical care throughout the study. Participants will be monitored for up to 12 months to evaluate the effectiveness of ESD for gastrointestinal lesion treatment. Researchers will review outcomes such as en-bloc resection rate, complete and curative resection rates, and safety including adverse events. No experimental treatments are given, and the study focuses on real-world clinical outcomes with standard care.

CONDITIONS

Brief Title

Endoscopic Submucosal Dissection (ESD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled to undergo Endoscopic Submucosal Dissection (ESD)
Not Eligible

You will not qualify if you...

  • Any contraindication to performing endoscopy
  • Participation in another research study that could affect the outcomes of this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo Endoscopic Submucosal Dissection (ESD), an outpatient procedure to remove deep tumors from the gastrointestinal tract as part of routine medical care.

1 visit (outpatient procedure day)

Long-term Monitoring

Duration - Up to 12 months

Participants are observed for up to 12 months to evaluate clinical outcomes including effectiveness and safety of the ESD procedure.

Follow-up visits according to routine medical care

Trial Site Locations

Total: 1 location

1

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

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Research Team

D

Dennis Yang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging.

Dennis Yang, Mihir S Wagh, Peter V Draganov

https://pubmed.ncbi.nlm.nih.gov/32504699

Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis.

Lorenzo Fuccio, Cesare Hassan, Thierry Ponchon...

https://pubmed.ncbi.nlm.nih.gov/28254526