Endoscopic Sutures For Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Endoscopic Sutures For Gastrointestinal Tract Disorders: A Prospective Multicenter Registry.

The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Study Overview

• Status: Unknown
• Conditions: Endoscopic Suturing Within the Gastrointestinal Tract
• Intervention / Treatment: Procedure: Endosuturing

Detailed Description

Our institution performs therapeutic Interventional Endoscopy in around 500-1000 patients a year. We come across several gastrointestinal disorders such as fistula or leak repairs, gastric outlet revisions, (dilated anastomoses), stent migrations, gastric wall defects or perforation, ulcer repairs, closure of transgastric entrance after a NOTES procedure (Natural orifice translumenal endoscopic surgery) that require placement of sutures and/or approximation of soft tissue.

Conventionally, surgery or other endoscopic alternatives are used to resolve or mitigate these issues. However, surgery had higher morbidity and mortality rates, and other endoscopic alternatives may not be successful either.

With the advent of endoscopic suture systems such as the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch), advanced endoscopists can place endoscopic sutures by deploying multiple running and interrupted stitches with a single insertion of the endoscope within the gastrointestinal tract.

Currently, the endoscopy unit uses the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) for suture placement in various gastrointestinal disorders; including suturing stents to prevent stent migration in the esophagus. Even though several case reports and animal studies have been published reporting the clinical success of endoscopic suturing, there have been hardly any large sample size studies to verify the safety and efficacy of endoscopic suturing. Our own study reported 12 cases with promising results for esophageal stent subjects. 1-16 We lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.

The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Study Design: Prospective, observational, medical chart review for at least 6 standard of care visits up to 1 year after subject consents for study participation.

Interventions: None

Subject Participation: Subject's participation in this study will allow us to collect data for at least 6 standard of care visits up to 1 year after consenting to participating in this registry study.

Subject will undergo a standard of care or clinically indicated Endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. Subject will sign a separate clinical consent for the Endoscopic procedure and placement of the sutures(s). That consent form will explain the procedure as well as the risks involved with the procedure.

Subject will undergo endoscopic suturing and subsequent follow up clinic visits regardless of their participation in this study. Subject will undergo no additional tests and procedures as part of this study.

This registry study allows for the prospective review and collection of clinical data related to endoscopic suturing for safety and efficacy assessment.

Study duration: At least 6 standard of care visits up to 1 year for each subject

• Once the subject consents, data will be collected for their clinically indicated or standard of care procedure visit and follow up visits.
• Standard of care follow up visits for endoscopic suturing are usually 1 month, 3 months and 6 months post procedure. No additional research related visits will be requested.
• All data will be collected from Medical charts.
• No subject surveys or questionnaires will be administered.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • Recruiting
      • Ochsner Health Center - Kenner
      • Contact: Virendra Joshi, MD; Phone Number: 504-464-8588; Email: vjoshi@ochsner.org
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
      • Sub-Investigator: Reem Z Sharaiha, MD
  • Texas
    • Dallas, Texas, United States, 75208
      • Recruiting
      • Digestive Health Associates of Texas
      • Contact: Prashant Kedia, MD; Phone Number: 214-941-6891; Email: prashant.kedia@dhat.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract.

Description

Inclusion Criteria:

• Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
• Above or equal to 18 years of age

Exclusion Criteria:

• Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
• Below 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic suturing; Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract.	Procedure: Endosuturing; Endoscopic suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Documentation of technical success and clinical outcome rates. Technical success will be documented via number of sutures successfully placed. Clinical success will be documented via follow up of resolution of symptoms of primary indication and number of repeat interventions or other interventions for the same indication.	6 months to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.	30 days post procedure

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 26, 2017
• Study Completion (Anticipated): August 26, 2017

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: sleeve gastrectomy; gastric bypass; suturing; esophageal stent
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 1207012584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No