Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Methodist Hospital System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01107249
First received: April 9, 2010
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing. [ Time Frame: 15 - 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • An institutional protocol for stent management [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Results will be considered for assessing and instituting an institutional protocol to become the standard of care for future patient situations.
Estimated Enrollment: 25
Study Start Date: May 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Boston Scientific Ultraflex or Wallstent stents
    Stent placement and removal for esophageal and/or gastric leaks, perforations and/or fistulas.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107249

Contacts
Contact: Darrel Cleere, RN, CCRP 713-441-6232 dwcleere@tmhs.org

Locations
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Darrel Cleere, RN, CCRP    713-441-6232    dwcleere@tmhs.org   
Principal Investigator: Shanda Blackmon, MD         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Shanda H Blackmon, MD The Methodist Hospital System
  More Information

No publications provided

Responsible Party: Shanda Blackmon, MD, The Methodist Hospital
ClinicalTrials.gov Identifier: NCT01107249     History of Changes
Other Study ID Numbers: 1108-0322
Study First Received: April 9, 2010
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
esophageal
stenting
perforations
gastric
esophageal stenting

ClinicalTrials.gov processed this record on March 03, 2015