Esophageal StricturesPhase 2NCT02751333
Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
A Phase 2 study testing FCSEMS with Endostitch (ES), FCSEMS with No Suturing (NS) and Fully Covered Self-Expanding Metal Stents (FCSEMS) in people with Esophageal Strictures and Esophageal Leak, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Esophageal Strictures, Esophageal Leak, Esophageal Perforation
- What is being tested?
- FCSEMS with Endostitch (ES), FCSEMS with No Suturing (NS) and Fully Covered Self-Expanding Metal Stents (FCSEMS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Esophageal Strictures, Esophageal Leak, Esophageal Perforation, Esophageal Fistula, Endostitch, Esophageal Stent
- Being tested
- FCSEMS with Endostitch (ES), FCSEMS with No Suturing (NS), Fully Covered Self-Expanding Metal Stents (FCSEMS), EndoStitch (ES) with the OverStitchTM system
- Keywords
- Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent
- Medical subject headings
- Esophageal Stenosis, Esophageal Perforation, Esophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCSEMS with Endostitch (ES)Procedure or surgery
The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
FCSEMS with No Suturing (NS)Procedure or surgery
The insertion of FCSEMS with no suturing.
Fully Covered Self-Expanding Metal Stents (FCSEMS)Device
This is the stent that will be used to treat the esophageal pathology in both groups
EndoStitch (ES) with the OverStitchTM systemDevice
This is the device used to apply the stitches to the stent in participants randomized to stent suturing.
| Study group | Role | What they receive |
|---|---|---|
| FCSEMS with Endostitching (ES) | Active comparator | 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. Receives: Procedure: FCSEMS with Endostitch (ES); Device: Fully Covered Self-Expanding Metal Stents (FCSEMS); Device: EndoStitch (ES) with the OverStitchTM system |
| FCSEMS with No Suturing (NS) | Active comparator | 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. Receives: Procedure: FCSEMS with No Suturing (NS); Device: Fully Covered Self-Expanding Metal Stents (FCSEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (4)
Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
Dysphagia relief as assessed by the validated dysphagia score
Measured: 4 weeks, 6 months post-stent removal
Procedure time
Time required for stent placement with/without endostitch
Measured: During procedure
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.
Measured: 3 days post-stent insertion, 4 weeks post-stent removal
Quality of life
Quality of life as measured by the SF-36 (Short Form health survey) questionnaire
Measured: prior to stent insertion and 6 months post-stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: The reason was the fact that the study was not clinically feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StricturesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen Khashab, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751333
- Sponsor's protocol ID
- IRB00091684
- Status last verified
- May 2017
- First submitted
- 18 Apr 2016
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02751333
- Acronym / sponsor ID
- IRB00091684
- Conditions
- Esophageal Strictures, Esophageal Leak, Esophageal Perforation, Esophageal Fistula, Endostitch, Esophageal Stent
- Keywords
- Esophageal stricture, Esophageal leak, Esophageal perforation, Esophageal fistula, Endostitch, Esophageal stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The reason was the fact that the study was not clinically feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCSEMS with Endostitching (ES) | Active comparator | Procedure: FCSEMS with Endostitch (ES), Device: Fully Covered Self-Expanding Metal Stents (FCSEMS), Device: EndoStitch (ES) with the OverStitchTM systemGeneral 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. |
| FCSEMS with No Suturing (NS) | Active comparator | Procedure: FCSEMS with No Suturing (NS), Device: Fully Covered Self-Expanding Metal Stents (FCSEMS)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCSEMS with Endostitch (ES)The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration. | Procedure or surgery | FCSEMS with Endostitching (ES) |
| FCSEMS with No Suturing (NS)The insertion of FCSEMS with no suturing. | Procedure or surgery | FCSEMS with No Suturing (NS) |
| Fully Covered Self-Expanding Metal Stents (FCSEMS)This is the stent that will be used to treat the esophageal pathology in both groups | Device | FCSEMS with Endostitching (ES), FCSEMS with No Suturing (NS) |
| EndoStitch (ES) with the OverStitchTM systemThis is the device used to apply the stitches to the stent in participants randomized to stent suturing. | Device | FCSEMS with Endostitching (ES) |
Primary outcome
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.
4 secondary outcomes
Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia
Time frame: 4 weeks, 6 months post-stent removal
Procedure time
Time frame: During procedure
Stent insertion complication rate
Time frame: 3 days post-stent insertion, 4 weeks post-stent removal
Quality of life
Time frame: prior to stent insertion and 6 months post-stent removal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mouen Khashab, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FCSEMS with Endostitch (ES), FCSEMS with No Suturing (NS) and Fully Covered Self-Expanding Metal Stents (FCSEMS) in people with Esophageal Strictures and Esophageal Leak, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.