Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

NCT02751333 | Withdrawn Phase 2 DMC

• 1 other identifier: IRB00091684
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Esophageal stricture; Esophageal leak; Esophageal perforation; Esophageal fistula; Endostitch; Esophageal stent

Outcome Measures

Primary Outcomes (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.

  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.

  Up to 6 months

Secondary Outcomes (4)

• Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia

  4 weeks, 6 months post-stent removal

• Procedure time

  During procedure

• Stent insertion complication rate

  3 days post-stent insertion, 4 weeks post-stent removal

• Quality of life

  prior to stent insertion and 6 months post-stent removal

Study Arms (2)

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 Once the stent is in place, the endoscope will be withdrawn from the participant to set-up the endostitch device unto the endoscope.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

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.

Procedure: FCSEMS with No Suturing (NS); Device: Fully Covered Self-Expanding Metal Stents (FCSEMS)

Interventions

FCSEMS with Endostitch (ES) PROCEDURE

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

FCSEMS with Endostitching (ES)

FCSEMS with No Suturing (NS) PROCEDURE

The insertion of FCSEMS with no suturing.

FCSEMS with No Suturing (NS)

Fully Covered Self-Expanding Metal Stents (FCSEMS) DEVICE

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

FCSEMS with Endostitching (ES); FCSEMS with No Suturing (NS)

EndoStitch (ES) with the OverStitchTM system DEVICE

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

FCSEMS with Endostitching (ES)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis; Esophageal Perforation; Esophageal Fistula

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Wounds and Injuries; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mouen Khashab, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 26, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (1)