Endoscopic full-thickness biopsy of the gastric wall with defect closure by using an endoscopic suturing device: survival porcine study.

BACKGROUND: The pathogenesis of several common gastric motility diseases and functional GI disorders remains essentially unexplained. Gastric wall biopsies that include the muscularis propria to evaluate the enteric nervous system, interstitial cells of Cajal, and immune cells can provide important insights for our understanding of the etiology of these disorders. OBJECTIVES: To determine the technical feasibility, reproducibility, and safety of performing a full-thickness gastric biopsy (FTGB) by using a submucosal endoscopy with mucosal flap (SEMF) technique; the technical feasibility, reproducibility, and safety of tissue closure by using an endoscopic suturing device; the ability to identify myenteric ganglia in resected specimens; and the long-term safety. DESIGN: Single center, preclinical survival study. SETTING: Animal research laboratory, developmental endoscopy unit. SUBJECTS: Twelve domestic pigs. INTERVENTIONS: Animals underwent an SEMF procedure with gastric muscularis propria resection. The resultant offset mucosal entry site was closed by using an endoscopic suturing device. Animals were kept alive for 2 weeks. MAIN OUTCOME MEASUREMENTS: The technical feasibility, reproducibility, and safety of the procedure; the clinical course of the animals; the histological and immunochemical evaluation of the resected specimen to determine whether myenteric ganglia were present in the sample. RESULTS: FTGB was performed by using the SEMF technique in all 12 animals. The offset mucosal entry site was successfully closed by using the suturing device in all animals. The mean resected tissue specimen size was 11 mm. Mean total procedure time was 61 minutes with 2 to 4 interrupted sutures placed per animal. Histology showed muscularis propria and serosa, confirming full-thickness resections in all animals. Myenteric ganglia were visualized in 11 of 12 animals. The clinical course was uneventful. Repeat endoscopy and necropsy at 2 weeks showed absence of ulceration at both the mucosal entry sites and overlying the more distal muscularis propria resection sites. There was complete healing of the serosa in all animals with minimal single-band adhesions in 5 of 12 animals. Retained sutures were present in 10 of 12 animals. LIMITATIONS: Animal experiment. CONCLUSIONS: FTGB by using the SEMF technique and an endoscopic suturing device is technically feasible, reproducible, and safe. Larger tissue specimens will allow improved analysis of multiple cell types.

Natural orifice translumenal endoscopic surgery used for perforated viscus repair is feasible using lower peritoneal pressures than laparoscopy in a porcine model.

BACKGROUND: Procedure-related complications contribute to 1-year mortality in patients with perforated ulcers. Natural orifice translumenal endoscopic surgery (NOTES) might offer a new repair approach. STUDY DESIGN: Swine were randomized to laparoscopic or NOTES repair. Laparoscopic gastrotomy creation (1 cm) was followed by 4 hours soilage time. After peritoneal cavity irrigation (per group assignment), repair proceeded with a laparoscopic or NOTES approach. For NOTES repair, omentum was endoscopically grasped, pulled into the gastric lumen, and fixed with metallic clips. Feasibility; time to complete procedures; pneumoperitoneal pressures; and clinical parameters, including necropsy and peritoneal culture at 2 weeks, were recorded. RESULTS: NOTES repair failed in 1 animal (technical); repair was completed laparoscopically, and data were analyzed as intention to treat. Specific NOTES repair time (minutes) was comparable with laparoscopy (36 versus 46; p = 0.2). Mean abdominal pressure (mmHg) required to complete NOTES repair was lower than in laparoscopy (4 versus 12; p < 0.001). Nineteen of 23 animals thrived until necropsy at 2 weeks. Three animals succumbed to airway compromise in recovery; 1 NOTES animal failed to thrive on postoperative day 7. No intra-abdominal cause for these deaths was found. At necropsy all repairs were intact, and peritoneal cultures revealed a small and equivalent amount of colony-forming units in each group. CONCLUSIONS: Endoscopic ulcer repair appears technically feasible with similar clinical and infectious outcomes to laparoscopy. The lower required pneumoperitoneal pressures used in these NOTES techniques are recognizable different outcomes from laparoscopy and can be advantageous in critically ill patients.

Preliminary performance of a flexible cap and catheter-based endoscopic suturing system.

BACKGROUND: Translation of natural orifice transluminal endoscopic surgery (NOTES) into clinical applications requires efficient and reliable enterotomy closure. OBJECTIVE: To evaluate a prototype endoscopic suturing system for enterotomy closure. DESIGN: This study took place in an ex vivo animal laboratory. Isolated porcine stomachs were contained within a plastic molded abdominal torso. The device specifications included a curved needle, end-cap assembly with a side-mounting wire-actuation channel, a needle-exchange assembly that operates within an endoscopic working channel, and a detachable needle tip attached to suture material. INTERVENTIONS: Mucosal templates (3-cm circular markings) for targeted suture placement were created along the anterior wall of the stomach (cardia, antrum, and body). Device performance and functionality were studied in 3 ways: suture placement, purse-string closure, and edge-to-edge gastrotomy closure. Interrupted and running stitches were placed with the endoscope straight and retroflexed. Simple leak testing was conducted. RESULTS: Sutures could accurately be placed at preset templated markings. Creation of a purse-string gastrotomy closure confirmed the capability to place a set of circumferential full-thickness running sutures during a single endoscopic intubation that resulted in a leak-proof closure. Edge-to-edge full-thickness tissue apposition was accomplished, which provided a water-tight closure of an 18-mm gastrotomy. The device worked consistently, without any problems. CONCLUSIONS: This endoscopic suturing device provided accurate placement of full-thickness sutures during a single intubation and permitted satisfactory tissue apposition. Standardized leak testing is needed for further development and evaluation of new devices. The catheter-driven needle actuator and the transfer-component system were intuitive and universally adaptable to any endoscope. This closure device may advance transluminal therapies by offering a secure, efficient method of hollow viscus closure.

Anatomical considerations for natural orifice translumenal endoscopic surgery.

Success in surgical procedures relies on the surgeon's understanding of anatomy and the ways in which the internal organs relate to one another. Recently, a new surgical technique has been introduced. Natural orifice translumenal endoscopic surgery (NOTES) uses the body's natural orifices (mouth, anus, urethra, or vagina) as entrance points to the peritoneal cavities (through the stomach, rectum, bladder, or posterior vaginal fornix). NOTES techniques have proven feasible in both animal and early human trials. While it remains to be seen what advantages NOTES possesses over traditional surgical approaches, a clear understanding of human anatomy will be critical for successful, safe NOTES procedures. This article summarizes the development and the basic techniques of NOTES and reviews those anatomical considerations specific to NOTES.

Surgeons without scalpels. A review of natural orifice translumenal endoscopic surgery.

Natural orifice translumenal endoscopic surgery (NOTES) is a new technique that allows access to the peritoneal cavity without passing through the anterior abdominal wall. This article reviews the evolution of NOTES and describes how it is currently being evaluated in animal models. It also discusses the potential benefits of the technique as well as the challenges it faces.