Feasibility, efficacy and safety of a pure natural orifice transluminal endoscopic gastrojejunostomy using a gastric outlet obstruction survival animal model

Introduction: Natural orifice translumenal endoscopic surgery is a less invasive surgical technique for creating a gastrojejunal anastomosis without the need of skin/parietal incisions. Such procedure may be useful for bariatric procedures and for treating gastric outlet obstruction. A pure natural orifice transluminal endoscopic gastrojejunostomy remains experimental and technically challenging despite many efforts in developing the technique. The aim of this study is to determine feasibility, efficacy and safety of a pure endoscopic NOTES gastrojejunal anastomosis procedure (GJA) using a simulated gastric outlet obstruction (pyloric closure) survival swine model.

Methods: This prospective animal study was carried out under University of Aix-Marseille ethical commitee approval. All procedures were performed on 20 to 30-kg domestic pigs, under general intravenous anesthesia and aseptic conditions, including sterilized double working channel endoscope and accessories. This procedure has been previously established according to our preliminary experience of performing a pure GJA on 7 animals (in press) as follows: 1/gastric incision with a needle-knife, 2/Access of the peritoneal cavity, 3/selection and presenting the jejunal loop for anastomosis, 4/translumenal transfer of the loop into the stomach, 5/exposure of the loop in the stomach using a stoma creation technique using a fully-covered metallic biliary stent, 6/incision of the loop, 7/a full thinckness GJ anastomosis with T-tag sutures using a prototype endoscopic suturing device (Brace Bar, Olympus, Japan), 8/removal of the stent. For the present experiment we added a pyloric closure procedure using the Brace Bar endoscopic suturing device. Antibioprophylaxis was administered for a 7 day-period. Animals we assessed daily for clinical outcome and ponderal changes. The pigs were euthanized after 3 weeks. The patency of the gastrojejunostomy (GJ) was confirmed at postmortem examination.

Results: In total, nine pure NOTES gastrojejunal by-pass procedures were performed. All the procedures were successfully achieved. The mean operative time was 108 ± 26 minutes [65–142]. Each GJA was endoscopically sutured using 4 to 7 T-tag sutures (mean of 5.55 ± 1.30). One or 2 T-tags were used for pyloric closure, There was no complications during the procedure. Five of 9 pigs survived for 3 weeks. Their mean weight was 29.5 kg at baseline versus 27.7 kg at 3 weeks follow-up. Diarrhea was observed in 4 pigs. Endoscopic contrast study confirmed that all the gastrojejunostomies were patent. The pylorus was most of the time incompletely closed. On postmortem examination, the GJA was about 50–60 mm in maximal diameter without evidence of stricture. Four pigs died from anastomotic dehiscence complicated with septic peritonitis.

Conclusion: GJA with pyloric closure is technically feasible using a pure NOTES approach using standard endoscopic equipment. This procedure is efficient resulting in a patent anastomosis and weight loss in all surviving animals.

Anastomotic dehiscence is a major a concern since it carries a high mortality rate because of ongoing contamination from the obstructed stomach. Further improvements for this model for reducing the risk of anastomotic dehiscence may be creation of a 2-step procedure in separate occasions (GJA anastomosis as the initial procedure followed by anastomotic dilatation and pyloric closure).