Clinical trial NCT02751333: Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
Official title: Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Strictures
Esophageal Leak
Esophageal Perforation
Esophageal Fistula
Endostitch
Esophageal Stent
Keywords: Esophageal stricture
Esophageal leak
Esophageal perforation
Esophageal fistula
Endostitch
Esophageal stent
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
timeFrame: 4 weeks, 6 months post-stent removal
measure: Procedure time
timeFrame: During procedure
measure: Stent insertion complication rate
timeFrame: 3 days post-stent insertion, 4 weeks post-stent removal
measure: Quality of life
timeFrame: prior to stent insertion and 6 months post-stent removal
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mouen Khashab, M.D.
role: PRINCIPAL_INVESTIGATOR
References: