In the era of minimally invasive surgery, the demand for endoscopic full-thickness suturing such as management of perforation or fistula and endoscopic gastrophilication is increasing. The endoclips do not allow full-thickness suturing in many cases, especially the stomach. And the suturing device currently in use is not yet widely used and has the disadvantage of not being able to control the direction of suturing. We developed a new endoscopic full-thickness suturing device that complements the shortcomings of the existing device and is capable of bidirectional suturing and control of suture direction and position. The aim of this study was to compare the novel endoscopic suturing device with hand-sewn techniques for gastro-tomy closure in expioporcine model. The suturing device consists of an end-effector with two jaws, a bundle of cables about one meter long, and a manual controller. The end-effector is mounted on the tip of gastroscope in an over-the-scope method. The end-effector performs suturing by using two jaws to exchange needle, and the suturing direction and position can be adjusted through a roll motion of end-effector. And the controller is designed to be intuitive and you can control three motions. For the end-effector to perform suturing. The suturing device has an additional instrument channel, and endoscopist can use an instrument such as forceps to grab tissue and pull it between the two jaws. First, endoscopist can open and close the jaw of the end-effector and then fix the needle on the left or right jaw. The end-effector has a roll motion that can rotate 19 degrees clockwise and counterclockwise. An additional instrument channel is designed between the two jaws of the end-effector. The operating range of the suturing device on the endoscope screen is as follows. Two jaws exchange needles, enabling suture in both directions, and rotation of 19 degrees clockwise and counterclockwise. As a result, endoscopist can suture in all directions. In addition, the forceps that through the additional channel pull this tissue between the two jaws, making it easy to perform full thickness suturing. Three experimental groups were set up. In each group, the experiment was repeated 10 times. A 2 cm long 4-layer perforation was made at the same location in the gastric gland region, lesser curvature side of the stomach of an adult pig. It was sutured according to the prescribed method, and the suturing time was measured. After the suturing was completed, the entire pig's stomach was placed in the water tank, and the internal air pressure was increased to measure the pressure at which leakage occurs at the suture site. In this video, you can see how the suturing device is used in an ex vivo experiment. First, fix the needle in the left jaw and then perform the first stitch on the tissue on the left side of the perforation. At this time, full thickness suture can be easily performed by pulling the tissue using forceps through the additional channel. After holding the needle in the left jaw to prevent thread twisting, perform a second stitch on the tissue on the right side of the perforation. If the suturing device is well positioned, full thickness suture can be performed without using forceps. After the second stitch, the endoscope is retracted to approximate the perforation. The third stitch is performed below the first stitch. If the needle is stuck in the tissue after stitching and does not come out easily, you can use the roll motion to change the direction of the needle and easily remove it by manipulating the endoscope. The final stitch is performed below the second stitch, and for solid suturing, the spacing between each stitch should be constant. After the stitch is completed, perform approximation by retracting the endoscope with the jaw closed. After performing approximation, you can observe the perforation is completely closed. Finally, the anchoring is performed on the normal tissue away from the perforation. After all processes are completed, insert endoscopic scissors into the endoscopic channel and cut off the remaining sutures. A leak test was performed to measure the strength of the suture. All open areas are sealed with clamps and zip tie, and the stomach sample is placed in the water tank. After that, air was injected into the stomach sample using an air pump, and the air leak pressure was measured. The leak pressure with the device was higher than with the clip and lower than with the hand-sewn suture. There was a statistically significant difference in leak pressure between the three groups. In the between-group analysis, there was no statistical difference in leakage pressure between the device group and the hand-sewn group. For procedure time, we excluded the case of hand-sewn suture because it was not an accurate surgical environment, and compared the case with the device and the case with the clip. In the case of the suture device, the procedure time was approximately 30% longer than when using the clip, and there was statistically significant difference. The novel suturing device has some unique advantages. First, the endoscopist can perform suturing in any direction desired by using bidirectional stitch and roll motion. It also has an additional channel, so it can be used with a single-channel endoscope, and full-thickness suturing can be easily performed using auxiliary instruments such as forceps. Lastly, it is designed with the intuitive controller, making it easy to use, and is expected to have a short learning curve compared to other suture techniques. In this X-view porcine stomach model, we demonstrated that the leak pressure of the novel endoscopic full-thickness suture was significantly higher than that of the endoclip closer, and that there was no significant difference from the hand-sewn technique. To evaluate efficacy and safety, further comparative studies with existing endoscopic suturing devices are necessary in the in vivo porcine model.

endoscopic full-thickness suturing device

bidirectional suturing

perforations

fistulas

ex vivo experiment