Gravity Assisted Technique for Esophageal Endoscopic Submucosal Dissection (ESD)

July 19, 2022 updated by: Mohamed Othman, Baylor College of Medicine

Prospective Assessment of the Gravity Assisted Technique for Esophageal Endoscopic

This is a prospective data recording study, all patients will receive standard medical care and no experimental interventions will be performed. All patients scheduled to undergo esophageal ESD from December 2018 to December 2021 as medically indicated will be considered for the study, Patients in whom esophageal ESD is considered as part of their standard medical care will be offered to participate in this study. The principle investigator who performing the procedure will also discuss the study with the subjects and ask them to sign a consent. If the patient agrees to participate, he/she will be given the informed consent form and allowed enough time to read it. Then if the patient agrees, he/she will sign the consent form. Data will be prospectively recorded according to the data collection form.

Study Overview

Status

Completed

Conditions

Detailed Description

Early precancerous esophageal lesions and esophageal cancer, are a threatening illnesses with high mortality rate, so the early intervention is critical during the course of treatment, statistically, every year an estimated 17,290 adults in the United States will be diagnosed with esophageal cancer. Esophageal cancer is the seventh most common cause of cancer death among men (1, 2). Giving the aggressive nature and fatality of esophageal cancer, the early management using the Endoscopic submucosal dissection is very essential (3).

Esophageal ESD is a technique that grants the en-block resection of lesions, with less morbidity and mortality when compared to surgery, and more efficient than other endoscopic techniques like endoscopic mucosal resection as ESD associated with higher curative resection rates and lower recurrence rates (4). ESD require experience and excellent training due to technique difficulties, longer procedure times and possible serious adverse events.

The esophageal Endoscopic Submucosal Dissection (ESD) is gaining momentum in United States. Although a great deal of training is focused on teaching how to utilize the equipment for performing the procedure, the strategy of where to start the incision and how to proceed with dissection is not yet standardized. The investigators standardized a technique for performing esophageal ESD utilizing gravity as traction to expedite the procedure.

Currently, the investigators are performing this technique for esophageal ESD at Baylor St. Luke's Medical center.

The aim of the study is to assess the mean time needed to perform esophageal ESD using this technique. Our quality metrics are a dissection rate of 9cm2 per hour as suggested by Japanese experts.

Purpose and objective of the study:

  1. - Assessing the mean time needed to perform esophageal ESD using this technique. Our quality metrics are a dissection rate of 9cm2 per hour as suggested by Japanese experts.
  2. - Assessment of the safety of gravity assisted esophageal ESD.

After obtaining the informed consent, the following information will be collected:

  1. - All the incisional times and the submucosal dissection time (details listed below)
  2. - Demographic information related to the study participants (age, sex, race, etc.)
  3. - BMI
  4. - Family History
  5. - The pathology reports for ESD.
  6. - Social habits such as smoking and drinking alcohol.

The investigator will collect the time that will be spent during this technique as following:

  1. - Lower incision time (anal side): this is the initial incision and will start at the anal side of the lesion
  2. - Right and left incisional time, these incisions will be on the each side of the lesion and they will meet the initial incision.
  3. - The proximal incision time (oral side): is performed at the oral side of the lesion communicating the right and left side incisions.
  4. - Total incision time.
  5. - Total submucosal dissection time.
  6. - Total procedure time

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled to undergo esophageal ESD from December 2018 to December 2021 as medically indicated will be considered for the study.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled to undergo esophageal ESD as part of their standard-of-care.

Exclusion Criteria:

  • Patients less than 18 years old.
  • Pregnant women
  • Patient is unable/unwilling to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time for lesion removal
Time Frame: 2 years
To assess the mean time needed to perform esophageal ESD using this technique.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 12, 2016

Primary Completion (ACTUAL)

January 14, 2021

Study Completion (ACTUAL)

February 4, 2022

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-44962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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