Clinical trial NCT01107249: A Trial of Esophageal and Gastric Stenting for Leak or Perforation
Official title: A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal or Gastric Perforations
Esophageal or Gastric Leaks
Keywords: esophageal
stenting
perforations
gastric
esophageal stenting
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
timeFrame: 15 - 30 days
measure: Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
timeFrame: 15 - 30 days
measure: A 30 day duration of stent placement and the relation to the healing esophagus
timeFrame: 30 days
Secondary outcomes:
measure: An institutional protocol for stent management
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Shanda H Blackmon, MD
role: PRINCIPAL_INVESTIGATOR
References: