CompletedPhase 2

A Trial of Esophageal and Gastric Stenting for Leak or Perforation

United States10 participantsStarted 2010-05

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.

Timeframe: 15 - 30 days

Efficacy of esophageal stenting by the success of leakage stops and fistula healing.

Timeframe: 15 - 30 days

A 30 day duration of stent placement and the relation to the healing esophagus

Timeframe: 30 days

Trial details

NCT IDNCT01107249

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Esophageal or Gastric Perforations trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.

Timeframe: 15 - 30 days

Efficacy of esophageal stenting by the success of leakage stops and fistula healing.

Timeframe: 15 - 30 days

A 30 day duration of stent placement and the relation to the healing esophagus

Timeframe: 30 days