A NOTES Survival Study of a Novel Gastric Closure Device: Loop-Anchor Purse-string

INTRODUCTION: Gastric closure is a key consideration in NOTES. Numerous closure methods have been reported, but none stands out as superior. Whatever the method, it should be effective, durable, tight, and easy to perform. We report our results with a new enteric closure device: Loop-Anchor Purse-String (LAPS).

METHODS: Our method was previously described on explanted stomachs. It comprises 4 T-anchors with metal loops suspended by the loops on a single 2-0 nylon suture. For this study we used 4 female pigs weighing 40 kg. Parenteral preoperative antibiotics, orogastric lavage with dilute betadine solution, and sterile technique were used insofar as possible. A percutaneous gastric puncture was made in the stomach as for PEG placement, and a guidewire was inserted and brought out through the mouth. Pneumoperitoneum was obtained using a Veress needle. Using a standard gastroscope, the T-anchors were then arrayed in a square pattern, 1.5-2 cm on a side, around the guidewire. The tract was then dilated over the wire to 18-mm. The stomach was exited with the endoscope still over the guidewire. A minor procedure was performed in the abdomen (deployment of an endoscopic tack into the abdominal wall) and the endoscope was then withdrawn. The gastrotomy was closed by cinching the suture tightly with a pushing catheter and securing it with a press-fit metal collar. The animals were then survived for 14 days, and gross examination upon necropsy as well as histologic examination of the closure site was performed.

RESULTS: The procedure times ranged from 50 minutes to 3 hours. Three of the four animals survived the postoperative period without sequellae and behaved normally. The fourth animal was sacrificed early due to signs of peritonitis; at necropsy only a microabscess was found near the abdominal wall tack. The animals were fed Ensure the next day and were advanced quickly to standard laboratory feeds. The three pigs that survived the 14 days all gained appropriate weight. None of the three survival animals developed fever, tachycardia, or any behavioral or physical signs of peritoneal irritation. On the 14th postoperative day the animals were sacrificed and the involved areas of stomach were harvested for gross and histologic analysis. Upon gross inspection there were no signs of peritoneal inflammation, intra-abdominal adhesions, or gastric spillage. The suture, T-anchors, and press-fit collars were still present. The looped T-anchors, which had been placed transmurally, had migrated into the submucosa. Histologic examination revealed gastric wall with focal, mucosal ulcer or focal mucosal regenerative changes. Dense granulation tissue, fibrosis, and foreign body type giant-cell reaction were seen in all specimens. The animal that was sacrificed prematurely had similar histologic findings.

CONCLUSION: LAPS provides a durable closure of the gastrotomy site in NOTES. The devices migrate inward and likely will slough. Three of the four laboratory animals survived placement and thrived without infectious or other adverse sequellae. LAPS is safe and effective when used for gastric closure in NOTES.

Session: Podium Presentation

Program Number: S061

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