Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Phase 2

Withdrawn

• Conditions: Esophageal Strictures; Esophageal Perforation; Esophageal Stent; Esophageal Leak; Esophageal Fistula; Endostitch
• Interventions: 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

• Registration Number: NCT02751333
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FCSEMS with Endostitching (ES)	EndoStitch (ES) with the OverStitchTM system	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.
FCSEMS with Endostitching (ES)	FCSEMS with Endostitch (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.
FCSEMS with No Suturing (NS)	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.
FCSEMS with Endostitching (ES)	Fully Covered Self-Expanding Metal Stents (FCSEMS)	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.
FCSEMS with No Suturing (NS)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy.	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

Name	Time	Method
Procedure time	During procedure	Time required for stent placement with/without endostitch
Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia	4 weeks, 6 months post-stent removal	Dysphagia relief as assessed by the validated dysphagia score
Stent insertion complication rate	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.
Quality of life	prior to stent insertion and 6 months post-stent removal	Quality of life as measured by the SF-36 (Short Form health survey) questionnaire

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States