Esophageal StenosisNCT04007692
Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation
An observational study of Esophageal Stenosis and Stent Migration, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stenosis, Stent Migration, Suture, Complication
- What is being tested?
- Esophageal stent placement
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 30 Nov 2020
- 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: Non-vulnerable adults who are receiving an endoscopically placed esophageal stent for any indication at Mayo Clinic Rochester.
Who may be able to join
- Subjects aged 18 or above
- Subjects undergoing esophageal stent placement with any indication
Who cannot join
- Imprisoned individuals,
- Institutionalized patients
- Inability or unwillingness of individual
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Suturing Pattern for Endolumenal Stenting Procedures
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.
Read the detailed description
The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.
- Conditions
- Esophageal Stenosis, Stent Migration, Suture, Complication
- Being tested
- Esophageal stent placement
- Keywords
- Esophageal stenosis, Endoscopic suturing, Esophageal stent fixation, Stent migration
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal stent placementProcedure or surgery
Exposure of interest is standard of care esophageal stent placement
| Study group | Role | What they receive |
|---|---|---|
| Simple interrupted suture group | Participants will have a simple interrupted suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up. Receives: Procedure: Esophageal stent placement | |
| Triangular suture group | Participants will have a triangular suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up. Receives: Procedure: Esophageal stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent migration rate
Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement
Measured: 4 weeks post stent placement
Adverse Events
Number of adverse events reported
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Aug 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: Accrual difficulties: This trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barham K. Abu Dayyeh, M.D., Mayo Clinic
- Investigators
- Barham K Abu Dayyeh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007692
- Sponsor's protocol ID
- 18-003817
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suturing Pattern for Endolumenal Stenting Procedures
- ClinicalTrials.gov ID
- NCT04007692
- Acronym / sponsor ID
- 18-003817
- Conditions
- Esophageal Stenosis, Stent Migration, Suture, Complication
- Keywords
- Esophageal stenosis, Endoscopic suturing, Esophageal stent fixation, Stent migration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual difficulties: This trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 5 Jul 2019 (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.
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.
Detailed description
The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple interrupted suture group | – | Procedure: Esophageal stent placementParticipants will have a simple interrupted suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up. |
| Triangular suture group | – | Procedure: Esophageal stent placementParticipants will have a triangular suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-vulnerable adults who are receiving an endoscopically placed esophageal stent for any indication at Mayo Clinic Rochester.
Key inclusion criteria (2 listed)
- Subjects aged 18 or above
- Subjects undergoing esophageal stent placement with any indication
Key exclusion criteria (3 listed)
- Imprisoned individuals,
- Institutionalized patients
- Inability or unwillingness of individual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal stent placementExposure of interest is standard of care esophageal stent placement | Procedure or surgery | Simple interrupted suture group, Triangular suture group |
Primary outcome
Stent migration rate
Time frame: 4 weeks post stent placement
Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement
Adverse Events
Time frame: 4 weeks
Number of adverse events reported
Results and safety
The study was stopped early (reason given: Accrual difficulties: This trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Barham K Abu Dayyeh, MD 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 Esophageal Stenosis and Stent Migration, 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 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 was stopped early (reason given: Accrual difficulties: This trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.). Results are not available in the source record.
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?
Stent migration rate (time frame: 4 weeks post stent placement). The study lists 2 primary outcomes in all. 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 19 Sep 2024; AzTrials last refreshed its copy on 28 Oct 2026.