A Trial of Esophageal and Gastric Stenting for Leak or Perforation (ESO-stent)

Study Description

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Brief Summary:

Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.

Condition or disease	Intervention/treatment	Phase
Esophageal or Gastric Perforations; Esophageal or Gastric Leaks	Device: Boston Scientific Ultraflex or Wallstent stents	Phase 2

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

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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

Arms and Interventions

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Arm	Intervention/treatment
BS Ultraflex or Wallstent stents; All subjects receive a stent of surgeons choice from selected stents.	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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
2. 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.
3. 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:

1. Patients who will not agree to return for routine follow-up and studies.
2. 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).
3. 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.
4. Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.

Contacts and Locations

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Locations

United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

The Methodist Hospital System

Investigators

Principal Investigator:	Shanda H Blackmon, MD	The Methodist Hospital System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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