Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Esophageal Fistula Clinical Trial

Official title:

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02751333
• Other study ID #: IRB00091684
• Status: Withdrawn
• Phase: Phase 2
• First received: April 18, 2016
• Last updated: May 11, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.

Description:

The use of removable, fully covered self-expanding metal stents (FCSEMS) in the management of benign esophageal pathology has been increasingly applied in recent years. Several studies have shown promising results with its application in esophageal perforation, fistula, or leak, and refractory benign strictures. However, the major limiting factor to successful treatment with FCSEMS in this setting is the substantial migration rates.

Different strategies has been used to secure esophageal stents but to little success. Several tertiary institutions including investigators have adopted the use of endostitch (ES) with the OverStitchTM system (Apollo Endosurgery, Austin, Texas) as the preferred method for stent fixation. Animal ex-vivo studies have confirmed the greater anchoring ability and tensile strength with this method when compared to esophageal stenting alone or with through the endoscope clip fixation while retrospective series have shown promising results with lower rates of stent migration when compared to conventional stent insertion. However, although the use of endostitch stent fixation has been used in several centers in the United-States with strong retrospective data (including investigators data), no prospective randomized controlled trial have confirmed its effectiveness in preventing stent migration.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adult patients age 18 years and older

2. Patients with esophageal refractory benign strictures (peptic, anastomotic, caustic, radiation, and idiopathic) where a 14 mm luminal diameter cannot be achieved over 2 dilation sessions at 1-3-week intervals.

3. Patients with esophageal leak, perforation, or fistula referred for endoscopic stenting

4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Pediatric patients age under 18 years

2. Pregnant or breastfeeding patients

3. Patients with malignant esophageal lesions, primary or metastatic, requiring endoscopic stenting (all females of child bearing age will undergo urine pregnancy testing as per standard1 preprocedural testing)

4. Benign strictures not having had two attempts at endoscopic dilation

5. Uncorrectable coagulopathy defined by partial thromboplastin time (PTT) greater than 50 sec, or international normalized ratio (INR) greater than 1.5

6. Uncorrectable thrombocytopenia with platelet count less than 50, 000

Related Conditions & MeSH terms

• Constriction, Pathologic
• Endostitch
• Esophageal Fistula
• Esophageal Leak
• Esophageal Perforation
• Esophageal Stenosis
• Esophageal Stent
• Esophageal Strictures
• Fistula

Intervention

Procedure:
• FCSEMS with Endostitch (ES)
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
• FCSEMS with No Suturing (NS)
The insertion of FCSEMS with no suturing.

Device:
• Fully Covered Self-Expanding Metal Stents (FCSEMS)
This is the stent that will be used to treat the esophageal pathology in both groups
• EndoStitch (ES) with the OverStitchTM system
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.	Subjects returning to the hospital following stent placement with symptoms suggestive of stent migration such as fever, abdominal or chest pain, nausea/vomiting, and dysphagia with objective evidence of stent migration either on radiological imaging or endoscopy.	Up to 6 months
Secondary	Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia	Dysphagia relief as assessed by the validated dysphagia score	4 weeks, 6 months post-stent removal
Secondary	Procedure time	Time required for stent placement with/without endostitch	During procedure
Secondary	Stent insertion complication rate	All complications related to stent insertion other than stent migration will be recorded with a preset questionnaire to measure the frequency of complications related to stent insertion.	3 days post-stent insertion, 4 weeks post-stent removal
Secondary	Quality of life	Quality of life as measured by the SF-36 (Short Form health survey) questionnaire	prior to stent insertion and 6 months post-stent removal