Gravity Assisted Technique for Esophageal Endoscopic Submucosal Dissection (ESD)

Esophageal Neoplasms Clinical Trial

Official title:

Prospective Assessment of the Gravity Assisted Technique for Esophageal Endoscopic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547881
• Other study ID #: H-44962
• Status: Completed
• Start date: December 12, 2016
• Est. completion date: February 4, 2022

Study information

• Verified date: July 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 4, 2022
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cao Y, Liao C, Tan A, Gao Y, Mo Z, Gao F. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy. 2009 Sep;41(9):751-7. doi: 10.1055/s-0029-1215053. Epub 2009 Aug 19. — View Citation

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time for lesion removal	To assess the mean time needed to perform esophageal ESD using this technique.	2 years

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