Utility of OverStitch Sx After ESD
Condition: Gastrointestinal Neoplasms
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This study is a prospective study where the investigators will make a database of all the
      patients who have received this procedure and will document various outcomes (i.e. number of
      sutures used, number of clips (if used), time required to close, complications/ issues). No
      changes will be done to the participant's procedure and the participants are asked to consent
      for the use of the participant's data in our database. The participants are being asked to be
      in this research study because the participants have been scheduled to undergo an ESD
      procedure at Baylor St. Luke Medical Center and will most likely require clipping and/or
      suturing following intervention. This study is important because this is a relatively new
      procedure; although it is a part of the participant's standard of care, it is not done in
      many hospitals. The investigators would like to document the outcomes and results of such
      procedures to continuously improve our standard of care.
    

Detailed description: 
      Resection of gastrointestinal neoplastic lesions at an early stage has been associated with
      improved clinical outcomes. While surgery has been traditionally performed for the resection
      of these precancerous or cancerous lesions confined to the mucosa of the GI tract, it is
      often associated with a higher morbidity and mortality rate compared to alternative
      endoscopic therapies. Recently, endoscopic submucosal dissection (ESD) has emerged as a new
      endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. In
      comparison to other endoscopic techniques, such as endoscopic mucosal resection (EMR), ESD is
      associated with higher curative resection rates and lower recurrence. While ESD was initially
      developed for the treatment of gastric cancer in Asia, which is relatively rare in the West,
      this technique would intuitively seem suitable for the resection of other superficial
      neoplastic lesions in the GI tract (i.e. large colon polyps, Barrett's mucosa, early
      non-invasive cancer). With the differences in patient population and disease location one can
      anticipate some differences in outcomes between ESD performed in Asian and US patients.
      Endoscopic Submucosal Dissection (ESD) is considered the gold standard for removal of
      pre-cancerous lesions from the GI tract, as histological analysis is more definitive, and the
      recurrence rate is lower as compared to endoscopic mucosal resection (EMR).

      While ESD is useful for therapeutic and diagnostic purposes, the technique is rather
      difficult and detailed requiring extended procedure times. The most common complications of
      the ESD techniques are bleeding and perforation. Other rare complications include aspiration
      pneumonia, air embolisms, or stenosis. For this reason, closure of the mucosa following an
      endoscopic resection became an area of increased interest.

      A randomized study in October of 2019 examined if prophylactic closure of a mucosal defect
      with clips would reduce the risk of bleeding following endoscopic intervention by EMR. 919
      patients were randomly assigned to groups with 3.5% of patients experiencing post-procedure
      bleeding compared to 7.1% within the control group. Through this randomized trial, they found
      a significant reduction in post-procedural bleeding when patients undergo endoscopic clip
      closure of the mucosal defect.

      With the advancements in endoscopic therapy, post-procedural clipping is now a
      well-established means of treatment following mucosal resections. Clipping, however, has two
      limitations including their inability to close large defects and the increasing difficulty in
      removal of those clips. To address these issues, endoscopic suturing systems have been
      developed which simulate the effectiveness of surgical stitching. The OverStitch Sx (Apollo
      Endosurgery Inc.) is commercially available and widely used in various applications such as
      the fixation of esophageal stents, suturing of ulcers, or reduction of anastamoses in
      bariatric surgeries.

      Kantsevoy et al. in a 2014 retrospective study has shown that large mucosal defects treated
      with endoscopic suturing following an ESD resulted in a decrease rate of adverse events as
      well as the need for hospitalizations. All patient lesions were successfully and completely
      closed with no delayed or immediate adverse events following the procedure. The study
      concludes that the use of the Overstitch Sx device is fast and feasible and can decrease
      treatment costs by reducing the need to hospitalize patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to/scheduled for ESD procedure at Baylor College of Medicine with
        possible mucosal defect closure.
      
Biospecimen description: 
      Gastrointestinal lesion/biopsy for pathological evaluation
    
Keywords: Gastrointestinal Neoplasms; OverStitch Sx; Endoscopic Submucosal Dissection