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NCT Number: NCT05468008

Endoscopic Submucosal Dissection (ESD)

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.

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Key information

Conditions

Esophageal Lesion Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Lesions Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location status: Recruiting

Location contact

Dennis Yang, MD

CONTACT

[email protected]

407-303-2570

About this study

The technique of Endoscopic Mucosal Resection (EMR) is currently widely used in the US to remove precancerous or cancerous lesions confined to the mucosa of the GI tract. EMR carries lower morbidity and mortality compare to surgery, at the expense of a higher rate of piecemeal removal, incomplete resection and cancer recurrence. Endoscopic Submucosal Dissection (ESD) is a newer technique developed in Japan that involves en-bloc resection of the entire lesion irrespective of size, allowing for a detailed analysis of the resected margins and depth of invasion and producing a lower local recurrence. Due to the lack of dedicated ESD devices the procedure has not been disseminated in Western countries. Recently the Food and Drug Administration (FDA) approved a number of devices for ESD. The vast majority of studies evaluating the clinical outcomes from ESD are originating in Japan where the technique is mostly applied to patients with early gastric cancer (Japan has the highest incidence of gastric cancer in the word). In the US lesions that are currently treated with EMR are mostly located in the esophagus (Barrett esophagus) and colon (large adenomatous polyps and intramucosal cancer). These esophageal and colonic lesions can be treated with ESD with expected higher rate of en-block resection and lower recurrence rate compare to EMR. With the differences in patient population and disease location one can anticipate some differences in outcomes between ESD performed in Asian and US patients. Therefore, the investigator wants to prospectively record the experience with ESD done as part of routine medical care in United States (US) population. This will be a prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Scheduled to undergo ESD

Exclusion criteria

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

Treatment and study plan

Endoscopic submucosal dissection

Procedure

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

Primary outcomes

  1. Evaluate the utility of ESD for treatment of gastrointestinal lesions

    Time frame: 12 months

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

Secondary outcomes

  1. En-Bloc Resection Rate

    Time frame: 6 months

    1)This is the proportion of lesions that are resected en-bloc (in one piece) using ESD

  2. Complete Resection Rate

    Time frame: 6 months

    • This is the proportion of lesions that are completely resected (clean lateral and deep resection margins) with ESD.

  3. Curative Resection Rate

    Time frame: 6 months

    • This is the proportion of lesions that are considered to have been cured based on endoscopic and histological criteria

  4. Safety- Adverse Events

    Time frame: 12 months

    • This will be measured based on the rate of adverse events with the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Yang, MD

CONTACT

[email protected]

407-303-2570

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in Western Population

Acronym: ESD

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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