S5211 Pilot Study of a Novel Device for Endoscopic Vacuum Therapy for Anastomotic Leak

Introduction: Gastrointestinal (GI) leaks are the result of perforation along the interior wall of the GI tract due to disease, trauma, or surgical complications. GI leaks increase the risk of mortality, infection, and hospital readmission. To date, stents have been the primary mode of treatment for a GI leak, however, wound vacuum-assisted closure (VAC) systems have been introduced as a method for sealing both external and internal wounds and leaks. Endoscopic vacuum therapy (EVT) is an emerging technology utilizing wound VAC systems for GI leaks. We have developed a novel EVT device consisting of a compressed pellet sponge and tube kit, which features a sponge encased in a dissolvable shell which expands upon positioning at the leak site. We present a single-center prospective pilot study to evaluate the safety and efficacy of this novel EVT device in treatment of GI leaks. Case Description: Patients diagnosed with an esophagogastric anastomotic leak were identified and enrolled in a prospective trial for a novel EVT device. The EVT device is guided through the esophagus and placed at the defect site under direct endoscopic visualization, and the external end is connected to a wound VAC unit which provides a negative pressure environment. The EVT device is exchanged every 3-7 days per protocol until the anastomotic leak has healed. Patient demographics, intraprocedural data, and outcomes data were collected and analyzed. Safety was defined as avoiding severe adverse events related to the EVT device during use. Efficacy was defined as the achievement of complete healing of the anastomotic leak using contrast-enhanced computed tomography (CT). A 65-year-old man with a history of gastroesophageal junction carcinoma who underwent laparoscopic trans-hiatal esophagogastrostomy with a course complicated by anastomotic leak was enrolled in the pilot study. EVT was initiated on post-operative day (POD) 6, and the EVT device was exchanged on POD 12, POD 16, and POD 20. Mean procedure time was 25.6 min (range: 24-30 min). Contrast-enhanced CT imaging demonstrated complete resolution of the anastomotic leak on POD 26, and the patient was discharged on POD 28. There were no adverse events related to the novel EVT device during the trial, or at 1-month follow up. Discussion: This case demonstrates that this novel EVT device provides a feasible and safe therapy for healing anastomotic leak.