search
Back to results

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Primary Purpose

Esophageal Strictures, Esophageal Leak, Esophageal Perforation

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FCSEMS with Endostitch (ES)
FCSEMS with No Suturing (NS)
Fully Covered Self-Expanding Metal Stents (FCSEMS)
EndoStitch (ES) with the OverStitchTM system
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Strictures focused on measuring Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FCSEMS with Endostitching (ES)

FCSEMS with No Suturing (NS)

Arm Description

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 Once the stent is in place, the endoscope will be withdrawn from the participant to set-up the endostitch device unto the endoscope.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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
Dysphagia relief as assessed by the validated dysphagia score
Procedure time
Time required for stent placement with/without endostitch
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.
Quality of life
Quality of life as measured by the SF-36 (Short Form health survey) questionnaire

Full Information

First Posted
April 18, 2016
Last Updated
May 11, 2017
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT02751333
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The reason was the fact that the study was not clinically feasible.
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Strictures, Esophageal Leak, Esophageal Perforation, Esophageal Fistula, Endostitch, Esophageal Stent
Keywords
Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FCSEMS with Endostitching (ES)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FCSEMS with No Suturing (NS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FCSEMS with Endostitch (ES)
Intervention Description
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
Intervention Type
Procedure
Intervention Name(s)
FCSEMS with No Suturing (NS)
Intervention Description
The insertion of FCSEMS with no suturing.
Intervention Type
Device
Intervention Name(s)
Fully Covered Self-Expanding Metal Stents (FCSEMS)
Intervention Description
This is the stent that will be used to treat the esophageal pathology in both groups
Intervention Type
Device
Intervention Name(s)
EndoStitch (ES) with the OverStitchTM system
Intervention Description
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.
Primary Outcome Measure Information:
Title
Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
Description
Dysphagia relief as assessed by the validated dysphagia score
Time Frame
4 weeks, 6 months post-stent removal
Title
Procedure time
Description
Time required for stent placement with/without endostitch
Time Frame
During procedure
Title
Stent insertion complication rate
Description
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.
Time Frame
3 days post-stent insertion, 4 weeks post-stent removal
Title
Quality of life
Description
Quality of life as measured by the SF-36 (Short Form health survey) questionnaire
Time Frame
prior to stent insertion and 6 months post-stent removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients age 18 years and older 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. Patients with esophageal leak, perforation, or fistula referred for endoscopic stenting Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Pediatric patients age under 18 years Pregnant or breastfeeding patients 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) Benign strictures not having had two attempts at endoscopic dilation Uncorrectable coagulopathy defined by partial thromboplastin time (PTT) greater than 50 sec, or international normalized ratio (INR) greater than 1.5 Uncorrectable thrombocytopenia with platelet count less than 50, 000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouen Khashab, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

We'll reach out to this number within 24 hrs