Gastrointestinal NeoplasmsESD RegistryNCT01415609
Endoscopic Submucosal Dissection Registry
An observational study of Gastrointestinal Neoplasms and Gastric Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Gastric Cancer
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for endoscopic treatment of gastrointestinal neoplasia.
Who may be able to join
None listed.
Who cannot join
- Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures.
- Patients who refuse or who are unable to consent.
- Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
- Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.
- Conditions
- Gastrointestinal Neoplasms, Gastric Cancer
- Keywords
- Gastrointestinal neoplasia, Submucosal resection
- Medical subject headings
- Gastrointestinal Neoplasms, Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use of the overall procedure and Time of procedure.
- Ease of use of overall procedure as rated on a 5-point visual analog scale for very easy, easy, neutral, difficult and very difficult.
- Time (in minutes) needed to resect the lesion completely, as measured from the first injection to final excision of the lesion.
Measured: 1 Year
Secondary outcomes (1)
Complications and Rate of Completion
- Minor and Major Bleeding
- Minor and Major perforation
- Post-polypectomy syndrome (defined as the presence of moderate or severe pain persisting more than 2 hours following completion of the procedure).
- Other(any other adverse event which the investigator feels is potentially attributable to the procedure).
- Enbloc resection of all endoscopically visible neoplasia
- Pathologically negative for lateral and/or deep margins
- Absence of residual neoplasia confirmed by repeat standard colonscopy and biopsy of ESD site 3-6 months following the index procedure.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Investigators
- Michael B Wallace, MD,MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415609
- Sponsor's protocol ID
- 10-000160
- Acronym
- ESD Registry
- Status last verified
- Nov 2012
- First submitted
- 10 Aug 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia
- ClinicalTrials.gov ID
- NCT01415609
- Acronym / sponsor ID
- ESD Registry / 10-000160
- Conditions
- Gastrointestinal Neoplasms, Gastric Cancer
- Keywords
- Gastrointestinal neoplasia, Submucosal resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Aug 2011 (estimated)
- 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.
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for endoscopic treatment of gastrointestinal neoplasia.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures.
- Patients who refuse or who are unable to consent.
- Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
- Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.
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
Ease of use of the overall procedure and Time of procedure.
Time frame: 1 Year
* Ease of use of overall procedure as rated on a 5-point visual analog scale for very easy, easy, neutral, difficult and very difficult. * Time (in minutes) needed to resect the lesion completely, as measured from the first injection to final excision of the lesion.
1 secondary outcome
Complications and Rate of Completion
Time frame: 1 Year
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 9 Nov 2012.
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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.
Michael B Wallace, MD,MPH principal investigator
Mayo Clinic
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 Gastrointestinal Neoplasms and Gastric Cancer, run by Mayo Clinic 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 0 inclusion and 4 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 9 Nov 2012. 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?
Ease of use of the overall procedure and Time of procedure. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2012.