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Safety of Novel Submucosal Injection Agent to Perform Per-Oral Pyloromyotomy: Single Center Pilot Study

Andrew T Strong, MD, Joshua P Landreneau, MD, MSc, Kevin El-Hayek, MD, FACS. Section of Surgical Endoscopy, Department of General Surgery Cleveland Clinic

Introduction: Endoscopic submucosal tunneling techniques such as per-oral esophago-myotomy or per-oral pyloromytomy (POP) rely on gaining access to a submucosal plane in the gastrointestinal tract. A fluid lift technique is typically used to facilitate accessing this space. Admixtures of dye and saline are most often used, they are readily available and inexpensive. However, these mixtures must be mixed at the bedside, and rapidly diffuses into the tissue, necessitating frequent re-injection. A novel submucosal injection agent recently approved for endoscopic resection, (Eleview™, Aries Pharmaceuticals). This novel solution contains dye, medium chain triglycerides, soluble polymeric thickener and an emulsifier in a premixed single use ampule. This study evaluated in this pilot study for utility in performing POP procedures.

Methods: After approval by the Institutional Review Board, consecutive patients undergoing POP therapy for medically refractory gastroparesis between November 2017 and May 2018 by a single endoscopist (KE) were identified and retrospectively reviewed. All submucosal injections were performed with a novel submucosal injection agent (Image 1). Outcome variables included procedure time and safety.

Results: During the study period, there were 38 patients included. There were 33 female (86%), with a mean ager of 46 years. The causes of gastroparesis were idiopathic in 50%, diabetes related in 26%, post surgical in 5.2% and multiple potential causes in 15.7%. Among the patients included, 38% had undergone prior surgical or endoscopic intervention for gastroparesis. The POP procedure was technically successful in all cases with a mean operative time of 23.9 minutes. There were no cases where re-injection was required to complete the POP. Visualization was noted to be temporarily compromised by bubbling of the injected solution in some cases (image 2). Most patients were discharged the same day (60.5%). There were two patients readmitted within 30 days, one with suspicion for perforation that was found to be negative, and one for delayed post procedural bleeding.

Conclusion: The use of a novel submucosal injection agent during POP appears to be safe and effective, and should be considered for use in endoscopic tunneling procedures. The long lasting fluid cushion avoids the need for re-injection, and it pre-mixed packaging reduces the change for medication errors associated with bedside compounding. Comparative studies should be performed to evaluate this novel submucosal injection agent standard saline lift technique for tunneling procedures.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 95324

Program Number: P434

Presentation Session: Poster Session (Non CME)

Presentation Type: Poster

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