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Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

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ClinicalTrials.gov Identifier: NCT02751333
Recruitment Status : Withdrawn (The reason was the fact that the study was not clinically feasible.)
First Posted : April 26, 2016
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Esophageal Strictures Esophageal Leak Esophageal Perforation Esophageal Fistula Endostitch Esophageal Stent Procedure: FCSEMS with Endostitch (ES) Procedure: FCSEMS with No Suturing (NS) Device: Fully Covered Self-Expanding Metal Stents (FCSEMS) Device: EndoStitch (ES) with the OverStitchTM system Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: FCSEMS with Endostitching (ES)
General anesthesia or conscious sedation will be started and an upper endoscope will be inserted into the participants mouth and advanced into the stomach. Endoscopic stenting with a fully covered self-expanding metal stents (FCSEMS) will then be performed. Once the stent is in place, the endoscope will be withdrawn from the participant to set-up the endostitch device unto the endoscope. Bites are taken separately with the first on the esophageal mucosa followed by a second on the stent itself and finishing with a last bite on esophageal mucosa. A cinch is then used to secure the deployed suture. An attempt at placing 2 sutures will be performed. Stent removal will then be performed at 8-weeks post-stent insertion.
Procedure: FCSEMS with Endostitch (ES)
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.

Device: Fully Covered Self-Expanding Metal Stents (FCSEMS)
This is the stent that will be used to treat the esophageal pathology in both groups

Device: EndoStitch (ES) with the OverStitchTM system
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.

Active Comparator: FCSEMS with No Suturing (NS)
The procedure will be done in the same manner with same endoscopic technique, stent deployment, and timing of stent removal. The only difference would be the lack of suturing and naturally the need for suture cutting at stent removal.
Procedure: 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




Primary Outcome Measures :
  1. Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy. [ Time Frame: Up to 6 months ]
    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.


Secondary Outcome Measures :
  1. Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia [ Time Frame: 4 weeks, 6 months post-stent removal ]
    Dysphagia relief as assessed by the validated dysphagia score

  2. Procedure time [ Time Frame: During procedure ]
    Time required for stent placement with/without endostitch

  3. Stent insertion complication rate [ Time Frame: 3 days post-stent insertion, 4 weeks post-stent removal ]
    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.

  4. Quality of life [ Time Frame: prior to stent insertion and 6 months post-stent removal ]
    Quality of life as measured by the SF-36 (Short Form health survey) questionnaire



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751333


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Mouen Khashab, M.D. Johns Hopkins University

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Responsible Party: Mouen Khashab, Associate professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02751333     History of Changes
Other Study ID Numbers: IRB00091684
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Mouen Khashab, Johns Hopkins University:
Esophageal stricture
Esophageal leak
Esophageal perforation
Esophageal fistula
Endostitch
Esophageal stent

Additional relevant MeSH terms:
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Fistula
Constriction, Pathologic
Esophageal Stenosis
Esophageal Fistula
Esophageal Perforation
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Fistula
Wounds and Injuries