Esophageal or Gastric PerforationsPhase 2ESO-stentNCT01107249
A Trial of Esophageal and Gastric Stenting for Leak or Perforation
A Phase 2 study testing Boston Scientific Ultraflex or Wallstent stents in people with Esophageal or Gastric Perforations and Esophageal or Gastric Leaks, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal or Gastric Perforations, Esophageal or Gastric Leaks
- What is being tested?
- Boston Scientific Ultraflex or Wallstent stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2014
- Phase
- Phase 2
- 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
Who may be able to join
- Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
- Patients will be required to undergo imaging with CT scan, endoscopy, or fluoroscopy to investigate the leak. Once the location of the leak is identified, then patients must be taken for stenting and any adjunctive treatment within 12 hours of diagnosis or within 12 hours of arrival to The Methodist Hospital.
- Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Who cannot join
- Patients who will not agree to return for routine follow-up and studies.
- Patients who will not tolerate an endobronchial ultrasound or endoscopic procedure (coagulopathy [INR>1.8, PTT>60, or platelet level <50], hemodynamically unstable [MAP<50 or SBP<80], or other medical illness precluding safe endoscopy).
- Patients who have a perforation too high to stent (such as the back of the pharynx, where a stent is not able to be placed), the only unfavorable anatomic location is this one listed above; we believe all other locations are amenable to stent placement.
- Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
Read the detailed description
This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the stent.
- Being tested
- Boston Scientific Ultraflex or Wallstent stents
- Keywords
- esophageal, stenting, perforations, gastric, esophageal stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Ultraflex or Wallstent stentsDevice
Also called Ultraflex, ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Stent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas.
| Study group | Role | What they receive |
|---|---|---|
| BS Ultraflex or Wallstent stents | Other | All subjects receive a stent of surgeons choice from selected stents. Receives: Device: Boston Scientific Ultraflex or Wallstent stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Measured: 15 - 30 days
Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Measured: 15 - 30 days
A 30 day duration of stent placement and the relation to the healing esophagus
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. Evaluation of the healing process of the esophagus within first 30 days with the capability of its removal procedure. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Measured: 30 days
Secondary outcomes (1)
An institutional protocol for stent management
Results will be considered for assessing and instituting an institutional protocol to become the standard of care for future patient situations.
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 posted20 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal or Gastric PerforationsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanda H Blackmon, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107249
- Sponsor's protocol ID
- Pro00002562
- Other IDs
- 1108-0322
- Acronym
- ESO-stent
- Status last verified
- Mar 2016
- First submitted
- 9 Apr 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data at this time. The PI has relocated to another institution and closed the IDE.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation
- ClinicalTrials.gov ID
- NCT01107249
- Acronym / sponsor ID
- ESO-stent / Pro00002562
- Keywords
- esophageal, stenting, perforations, gastric, esophageal stenting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Apr 2010 (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.
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
Detailed description
This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BS Ultraflex or Wallstent stents | Other | Device: Boston Scientific Ultraflex or Wallstent stentsAll subjects receive a stent of surgeons choice from selected stents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
- Patients will be required to undergo imaging with CT scan, endoscopy, or fluoroscopy to investigate the leak. Once the location of the leak is identified, then patients must be taken for stenting and any adjunctive treatment within 12 hours of diagnosis or within 12 hours of arrival to The Methodist Hospital.
- Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Key exclusion criteria (4 listed)
- Patients who will not agree to return for routine follow-up and studies.
- Patients who will not tolerate an endobronchial ultrasound or endoscopic procedure (coagulopathy [INR>1.8, PTT>60, or platelet level <50], hemodynamically unstable [MAP<50 or SBP<80], or other medical illness precluding safe endoscopy).
- Patients who have a perforation too high to stent (such as the back of the pharynx, where a stent is not able to be placed), the only unfavorable anatomic location is this one listed above; we believe all other locations are amenable to stent placement.
- Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.
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 |
|---|---|---|
| Boston Scientific Ultraflex or Wallstent stentsAlso: Ultraflex, ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMStent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas. | Device | BS Ultraflex or Wallstent stents |
Primary outcome
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
Time frame: 15 - 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
Time frame: 15 - 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
A 30 day duration of stent placement and the relation to the healing esophagus
Time frame: 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. Evaluation of the healing process of the esophagus within first 30 days with the capability of its removal procedure. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
1 secondary outcome
An institutional protocol for stent management
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 17 Mar 2016.
- Individual participant dataSharing planned: No. No plan to share data at this time. The PI has relocated to another institution and closed the IDE.
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.
Shanda H Blackmon, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Boston Scientific Ultraflex or Wallstent stents in people with Esophageal or Gastric Perforations and Esophageal or Gastric Leaks, run by The Methodist Hospital Research Institute 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 3 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 17 Mar 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing. (time frame: 15 - 30 days). The study lists 3 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 17 Mar 2016.