Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

NCT ID: NCT02751333

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-02-28

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.

Conditions

Esophageal Strictures; Esophageal Leak; Esophageal Perforation; Esophageal Fistula; Endostitch; Esophageal Stent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FCSEMS with Endostitch (ES)

Intervention Type: PROCEDURE

The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.

Fully Covered Self-Expanding Metal Stents (FCSEMS)

Intervention Type: DEVICE

This is the stent that will be used to treat the esophageal pathology in both groups

EndoStitch (ES) with the OverStitchTM system

Intervention Type: DEVICE

This is the device used to apply the stitches to the stent in participants randomized to stent suturing.

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.

Group Type: ACTIVE_COMPARATOR

FCSEMS with No Suturing (NS)

Intervention Type: PROCEDURE

The insertion of FCSEMS with no suturing.

Fully Covered Self-Expanding Metal Stents (FCSEMS)

Intervention Type: DEVICE

This is the stent that will be used to treat the esophageal pathology in both groups

Interventions

FCSEMS with Endostitch (ES)

The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.

Intervention Type: PROCEDURE

FCSEMS with No Suturing (NS)

The insertion of FCSEMS with no suturing.

Intervention Type: PROCEDURE

Fully Covered Self-Expanding Metal Stents (FCSEMS)

This is the stent that will be used to treat the esophageal pathology in both groups

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Mouen Khashab

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mouen Khashab, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00091684

Identifier Type: -

Identifier Source: org_study_id