A Trial of Esophageal and Gastric Stenting for Leak or Perforation (ESO-stent)
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ClinicalTrials.gov Identifier: NCT01107249 |
Recruitment Status
:
Completed
First Posted
: April 20, 2010
Last Update Posted
: March 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Esophageal or Gastric Perforations Esophageal or Gastric Leaks | Device: Boston Scientific Ultraflex or Wallstent stents | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
---|---|
BS Ultraflex or Wallstent stents
All subjects receive a stent of surgeons choice from selected stents.
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Device: Boston Scientific Ultraflex or Wallstent stents
Stent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas.
Other Name: Ultraflex, ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
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- 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.
- An institutional protocol for stent management [ Time Frame: 1 year ]Results will be considered for assessing and instituting an institutional protocol to become the standard of care for future patient situations.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107249
United States, Texas | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Shanda H Blackmon, MD | The Methodist Hospital System |
Responsible Party: | The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT01107249 History of Changes |
Other Study ID Numbers: |
Pro00002562 1108-0322 ( Other Identifier: HMRI IRB ) |
First Posted: | April 20, 2010 Key Record Dates |
Last Update Posted: | March 17, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share data at this time. The PI has relocated to another institution and closed the IDE. |
Keywords provided by The Methodist Hospital System:
esophageal stenting perforations gastric esophageal stenting |