Abstract
Endoscopic ultrasonography (EUS)-guided transmural drainage has been accepted as a modality of choice in peripancreatic fluid collection and acute cholecystitis. Each type of stent, including double-pigtail plastic stents, tubular self-expandable metal stents (SEMS), and lumen-apposing metal stents, for these procedure has its own advantages and disadvantages. To overcome their disadvantages, this animal study evaluated the feasibility of a newly designed twisted fully covered SEMS with spiral coiled ends. We performed the EUS-guided cholecystogastrostomy with a newly developed metal stent in eight mini pigs with surgically induced gallbladder distension. This novel stent is a twisted fully covered SEMS with spiral coiled ends, a diameter of 8 mm, and a length of 6 cm. The stent has been maintained for four to seven weeks after EUS-guided cholecystogastrostomy. The primary outcome was the technical success rate, and the secondary outcomes were adverse events, stent dysfunction, stent removability, and fistula formation. The stent was placed successfully between the gallbladder and the stomach in all cases without any adverse event. We observed neither stent migration nor dysfunction during the study period, and all the stents were removed easily as scheduled. We confirmed successful cholecysto-gastric fistula formation at endoscopic and histologic level in all cases. EUS-guided transmural drainage and fistula formation using a new twisted fully covered metal stent with spiral coiled ends was technically feasible without any adverse event in this animal study. Further clinical studies are needed to evaluate its efficacy and safety in real practice.
Highlights
Endoscopic ultrasonography (EUS)-guided transmural drainage has been accepted as a modality of choice in peripancreatic fluid collection and acute cholecystitis
We observed loss of muscle tissue and fibroblast hyperplasia with chronic inflammatory cell infiltration around the fistula tract. (Fig. 4). We conducted this animal study with a pig model to evaluate the feasibility, safety, and removability of a newly developed twisted, fully covered, self-expandable metal stent with spiral coiled ends (Tornado stent; S&G Biotech, Inc., Yongin, South Korea), which is expected to be removable after formation of the fistula while ensuring sufficient anchoring capability
We found that Tornado stent was placed successfully without technical difficulties or adverse events and removed while creating a firm fistula tract in all eight pigs
Summary
Endoscopic ultrasonography (EUS)-guided transmural drainage has been accepted as a modality of choice in peripancreatic fluid collection and acute cholecystitis. EUS-guided transmural drainage and fistula formation using a new twisted fully covered metal stent with spiral coiled ends was technically feasible without any adverse event in this animal study. Endoscopic ultrasonography (EUS)-guided transmural drainage is accepted as a modality of choice when drainage is required in several diseases, such as acute cholecystitis or peripancreatic fluid collection (PFC) including pancreatic pseudocysts, and walled-off necrosis of the p ancreas[1,2,3] Conventional approaches in these situations are to mount double-pigtail plastic stents (PS) or tubular self-expanding metal stents (SEMS). There is still a need to improve existing stents by developing newly designed stents The aims of this animal study with a pig model are to evaluate the feasibility, safety, and removability of the newly designed twisted, fully covered SEMS with spiral coiled ends
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