Therapeutic endoscopic ultrasound (EUS) has rapidly developed and become widespread in the last decade, and is currently applied to treat several challenging conditions, including drainage of peripancreatic fluid collections as a complication of acute pancreatitis, biliary drainage for malignant distal biliary obstruction, gallbladder drainage in frail patients with acute cholecystitis, and gastroenterostomy creation for malignant gastric outlet obstruction. Such an expansion has been made possible by the introduction of dedicated devices and stents, namely electrocautery-enhanced lumen-apposing metal stents (EC-LAMS). Three EC-LAMS are currently available on the market: Hot-Axios (Boston Scientific, USA), Niti-S Hot-Spaxus (Taewoong Medical, South Korea), and Hanarostent Hot Plumber Z-EUS IT (M.I. Tech, South Korea). While for the first two devices data on safety and efficacy are already available in the literature, for the latter only case reports are available to date. Our aim was therefore to assess the efficacy and safety of the Hanarostent Hot Plumber Z-EUS IT device in different therapeutic EUS indications.

For this retrospective, multicenter study, all consecutive patients undergoing therapeutic EUS for different indications using the Hanarostent Hot Plumber Z-EUS IT at 11 referral centers between December 2021 and October 2025 were enrolled. The primary aim was the technical success of the procedures performed with the device, defined as successful placement of the stent through the wall of the gastrointestinal tract into the target organ or cavity. Secondary aims were safety, defined as the rate of procedure-related adverse events (AEs), and clinical success, defined differently according to the specific procedure and indication. AEs were also stratified according to timing and severity. Relevant procedure-related clinical and technical data were collected.

Seventy-eight patients were enrolled (mean age 69 years, 45% female). Indications and procedures performed were as follows: 41 gallbladder (GB) drainages for acute cholecystitis; 30 pancreatic fluid collection (PFC) drainages; 4 choledochoduodenostomies for malignant biliary obstruction; 2 gastroenterostomies for malignant gastric outlet obstruction; and 2 drainages of intra-abdominal collections. The underlying condition was neoplastic in 33.3%. Technical success was achieved in 96.2% of cases. Among these, the clinical success rate was 100%. The 3 cases of technical failure were due to stent misdeployment in 2 cases, and inability to get access to the target cavity in 1 case. Fifty-seven (73.1%) procedures were performed under deep sedation or general anaesthesia, while the remaining 26.9% were performed under conscious sedation. Fluoroscopic assistance was necessary in 43.6% of cases. The most commonly used stent diameter was 10 mm (50%), followed by 16 mm (32.1%), 14 mm (12.8%), and 12 mm (5.1%). The 10-mm diameter stent was used in 78% of EUS-guided GB drainage, while the 16-mm stent was mostly used for PFC drainage. The most common stent length was 20 mm (83.3%). The access technique was free-hand in 87.2%; proximal release was intrachannel in 93.6%. Among GB drainages, 82.5% were performed through duodenal access. PFC drainage was followed by endoscopic necrosectomy in 33.3% of cases (90% delayed). Coaxial double pigtail plastic stents were placed in 14.7% of cases. Over a median follow-up time of 13 months, adverse events (AEs) occurred in 12.8% of patients, all graded I to III according to the AGREE classification. Of these, 50% occurred intraprocedurally (all misdeployments), 10% were early (≤ 7 days), and 40% were late. All AEs were treated conservatively or endoscopically, except one case of biliary peritonitis requiring surgery. No procedure-related deaths occurred.

This is the first study to assess the efficacy and safety of the EC-LAMS Hanarostent Hot Plumber Z-EUS IT device. This device demonstrated high technical and clinical success in different therapeutic EUS indications, with an acceptable safety profile. Prospective studies are warranted to confirm these findings.