Esophageal NeoplasmsNCT04547881
Gravity Assisted Technique for Esophageal Endoscopic Submucosal Dissection (ESD)
An observational study of Esophageal Neoplasms, run by Baylor College of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Neoplasms
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 4 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled to undergo esophageal ESD from December 2018 to December 2021 as medically indicated will be considered for the study.
Who may be able to join
- Age 18 years or older
- Scheduled to undergo esophageal ESD as part of their standard-of-care.
Who cannot join
- Patients less than 18 years old.
- Pregnant women
- Patient is unable/unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- - 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.
- - Assessment of the safety of gravity assisted esophageal ESD.
After obtaining the informed consent, the following information will be collected:
- - All the incisional times and the submucosal dissection time (details listed below)
- - Demographic information related to the study participants (age, sex, race, etc.)
- - BMI
- - Family History
- - The pathology reports for ESD.
- - Social habits such as smoking and drinking alcohol.
The investigator will collect the time that will be spent during this technique as following:
- - Lower incision time (anal side): this is the initial incision and will start at the anal side of the lesion
- - Right and left incisional time, these incisions will be on the each side of the lesion and they will meet the initial incision.
- - The proximal incision time (oral side): is performed at the oral side of the lesion communicating the right and left side incisions.
- - Total incision time.
- - Total submucosal dissection time.
- - Total procedure time
- Conditions
- Esophageal Neoplasms
- Keywords
- Endoscopic Submucosal Dissection, Gravity Assisted Technique
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time for lesion removal
To assess the mean time needed to perform esophageal ESD using this technique.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start12 Dec 2016
- Primary completion14 Jan 2021
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Othman, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547881
- Sponsor's protocol ID
- H-44962
- Status last verified
- Jul 2022
- First submitted
- 8 Sep 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21296855Torre 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.
PubMed 25651787Cao 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.
PubMed 19693750
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Gravity Assisted Technique for Esophageal Endoscopic
- ClinicalTrials.gov ID
- NCT04547881
- Acronym / sponsor ID
- H-44962
- Conditions
- Esophageal Neoplasms
- Keywords
- Endoscopic Submucosal Dissection, Gravity Assisted Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- - 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.
- - Assessment of the safety of gravity assisted esophageal ESD.
After obtaining the informed consent, the following information will be collected:
- - All the incisional times and the submucosal dissection time (details listed below)
- - Demographic information related to the study participants (age, sex, race, etc.)
- - BMI
- - Family History
- - The pathology reports for ESD.
- - Social habits such as smoking and drinking alcohol.
The investigator will collect the time that will be spent during this technique as following:
- - Lower incision time (anal side): this is the initial incision and will start at the anal side of the lesion
- - Right and left incisional time, these incisions will be on the each side of the lesion and they will meet the initial incision.
- - The proximal incision time (oral side): is performed at the oral side of the lesion communicating the right and left side incisions.
- - Total incision time.
- - Total submucosal dissection time.
- - Total procedure time
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled to undergo esophageal ESD from December 2018 to December 2021 as medically indicated will be considered for the study.
Key inclusion criteria (2 listed)
- Age 18 years or older
- Scheduled to undergo esophageal ESD as part of their standard-of-care.
Key exclusion criteria (3 listed)
- Patients less than 18 years old.
- Pregnant women
- Patient is unable/unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total time for lesion removal
Time frame: 2 years
To assess the mean time needed to perform esophageal ESD using this technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 21296855Jemal 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.
- Background: PubMed 25651787Torre 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.
- Background: PubMed 19693750Cao 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time for lesion removal (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547881, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.