Background: Endoscopic ultrasound- guided gastroenterostomy (EUS-GE) is a new treatment modality for gastric outlet obstruction, demonstrating advantages over enteral stenting and surgical bypass. The majority of reported procedures have been performed with only one electrocautery- enhanced lumen-apposing stent (LAMS) and data about other LAMSs are scarce. There is paucity of data in the literature about long-term symptom relief and factors associated with outcomes and adverse events.

Aim: To evaluate the safety and efficacy of EUS-GE to treat gastric outlet obstruction (GOO) using a novel electrocautery- enabled LAMS (Niti-S Hot SPAXUS, Taewoong Medical, Goyang, South Korea). Primary endpoints were adverse events (AEs) and factors associated with their occurrence. Secondary endpoints were technical success (establishment of an anastomosis), clinical success (tolerating semisolid food at 48 hours), procedure time, hospital stay and long term follow up data on symptom relief.

Methods: Retrospective single center study over a 2-year period. Demographic characteristics, procedure-related and follow-up data were collected.

Results: Forty patients were included. The most common indication was malignancy (87.5%), predominantly pancreatic cancer (55%), followed by gastric cancer (10%) and groove pancreatitis (7.5%). Technical success was achieved in 97.5%. Stent misdeployment (SM) occurred in 10% and was more frequent in younger (p=0.0067) and female (75% vs. 25%) patients. SM occurred exclusively in malignant indications (11.4% vs. 0%). There was no correlation with the presence of ascites, site of obstruction, technique, shape of target loop, previous interventions or surgically altered anatomy. All the cases were salvaged endoscopically. SM did not prolong the hospital stay (p= 0.481) and was only associated with prolongation of the procedure time. Immediate AEs (<24 hours) were reported in 2.5% and happened more frequently in younger age and peritoneal carcinomatosis (p=0.046). The rate of short-term AEs (<30 days) was 10% (n=4) occurring more frequently in the presence of ascites (p=0.078), in malignant etiology (p=0.048) and peritoneal carcinomatosis (p=0.046). Long-term AEs (>30 days) were reported in 15.8% and were significantly associated with malignant etiology (p= 0.021). Most adverse events were managed conservatively or were not clinically significant, only two patients required surgery. The median procedure time was 35 minutes (IQR 30–40), and the median hospital stay was 3 days (IQR 2–3) The clinical success was 92.5%, indicating high rate of early functional recovery. Six-month follow-up data were available for 15 patients (37.5%). Among them, 86.7% demonstrated complete clinical resolution. Late functional outcomes assessed using the gastric outlet obstruction scoring system (GOOSS score) showed that 94.9% of patients achieved a GOOSS of 3 or 2, indicating the ability to tolerate a full or almost full diet at longest follow-up. These findings suggest sustained symptomatic improvement in most patients with available follow-up data. Two patients are alive at 12 months and both tolerate normal diet. 

Conclusions: We demonstrated that EUS-GE using a novel electrocautery- enabled LAMS is a safe and highly effective procedure. The majority of patients tolerate normal diet at long term follow-up. SM happened rarely, mostly in young female patients with malignant indications but did not affect the outcome and was related only with prolonged procedure time. Malignant etiology and presence of peritoneal carcinomatosis are strongest risk factors for adverse events.