ENDOSCOPIC RE-CELLULARIZATION VIA ELECTROPORATION THERAPY (RECET)

Background: The field of bariatric endoscopy continues to evolve with the introduction of new technology and refinement of endoscopic techniques. Recently, the gastric antrum has gained interest as a potential novel therapeutic target. The gastric antrum represents the motor function of the stomach, and as such alteration to the antrum could result in changes that impact motor function and result in enhanced satiety and satiation. However, current endoscopic techniques for antrum reduction through per oral suturing have limitations with long-term durability. Therefore, we investigated the use of a modified gastrostomy tube (EndoTAGGS, Shawnee, KS) and non-cutting stapling device to reduce the gastric antrum.

Case Presentation: We demonstrated a novel approach to endoluminal gastroplasty using a modified gastrostomy tube and laparoscopic stapler. The procedure was successfully carried out in two porcine models. First, a modified gastrostomy tube (also called a percutaneous intragastric trocar (PIT)) was placed using a technique analogous to pull-through placement of a standard percutaneous gastrostomy tube. The distal tip of the tube is cut and a single 12-mm gastric port is attached. A 12-mm laparoscopic non-cutting stapler (Ethicon Inc., Raritan, NJ) is inserted through the port and into the stomach. A helical endoscopic tissue grasper (Apollo Endosurgery, Austin, TX) is used to secure and retract tissue into the jaws of the stapler, which is fired to create full-thickness imbrications of the stomach. The procedure is repeated multiple times along the anterior wall, greater curvature, and posterior wall until the stomach is reduced and tubularization is achieved.

Endoscopic Methods: The novel endoluminal gastroplasty procedure was successfully performed in two porcine models without immediate complications. Endoscopic images demonstrated sequential staple lines leading to effective reduction and tubularization of the antrum. During necropsy, full-thickness imbrications were found at the staple sites. There was no evidence of perforation at the staple site or trocar placement.

Conclusions: In conclusion, we were able to demonstrate a novel approach to endoluminal gastroplasty using a novel modified gastrostomy tube and laparoscopic stapler. The use of a PIT can overcome limitations of current endoscopic techniques by allowing for the use of larger diameter devices in a combined endoscopic/laparoscopic approach. Further studies are needed to refine the technique and explore therapy targeting antrum reduction in the treatment of obesity.

Background: One of the newest potential developments in endoscopy is the use of the duodenum as a therapeutic target for type 2 diabetes mellitus (T2DM). Endoscopic Re-Cellularization via Electroporation Therapy (ReCET) is a novel technology that utilizes a pulsed electrical field to create voltage gradient across living cells, triggering apoptosis. It is delivered through a generator, controller, and a flexible catheter with electrodes on an expandable flex circuit to deliver a 750v current on the duodenal mucosa. Compared to thermal-based technologies, ReCET is potentially safer as the energy delivery to the tissue is at a cellular level, thus it only penetrates superficial layer of the mucosa. We report herein the first case of a patient treated with ReCET therapy.

Methods: We present a case of a 68-year-old male with class I obesity (BMI 34.0 kg/m2) and type 2 diabetes mellitus in the past 5 years. His baseline HbA1c and fasting plasma glucose were 8.4% and 170 mg/dL, despite being on optimized doses of two oral antidiabetic medications. He was treated with ReCET therapy receiving a total of 7 doses of pulsed electrical field.

Results: ReCET therapy resulted in significant improvement in the patient’s diabetes-related parameters. His HBA1c reduced from 8.4% to 7.5%, 6.5%, and 6.8% at weeks 4, 12, and 24. His plasma glucose levels were monitored by a continuos glucose monitor (CGM), whose reports showed an improvement in the percentage of readings within normal range (baseline: 56%; week 4: 96%; week 12:100%; week 24: 96%).

Conclusions: ReCET is a novel and safe non-thermal modality that overcomes many limitations of thermal-based ablative energies and may help with altering disease progression in T2DM.