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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal or Gastric Perforations; Esophageal or Gastric Leaks
• Intervention / Treatment: Device: Boston Scientific Ultraflex or Wallstent 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Ultraflex, ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Shanda H Blackmon, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: stenting; gastric; esophageal; perforations; esophageal stenting
• Other Study ID Numbers: Pro00002562; 1108-0322 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data at this time. The PI has relocated to another institution and closed the IDE.