EUS-guided biliary drainage with a novel electrocautery-enhanced lumen apposing metal stent as first approach for distal malignant biliary obstruction: a prospective study

Abstract

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in malignant biliary obstruction (MBO) patients. Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. We aimed to assess the technical and clinical success of a new EC-LAMS as the first approach to the palliation of malignant jaundice due to MBO in patients unfit for surgery. Patients and methods Twenty-five consecutive patients undergoing endoscopic-guided biliary drainage with the new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease > 15 % 24 hours after EC-LAMS placement. Results Mean age was 76.6 ± 11.56 years, and male patients were 10 (40 %). EC-LAMS placement was technically feasible in 24 patients (96 %) and clinical success rate was 100 %. Only one patient (4 %) experienced a misplacement rescued by an immediate second EC-LAMS placement. The mean duration of hospital stay was 4.66 ± 4.22 days. The median overall survival was 7 months (95 % CI 1–7). Conclusions In this preliminary study, the new EC-LAMS seems to allow a single-step palliative endoscopic therapy in patients affected by jaundice due to MBO, with high technical and clinical success and low adverse events. Further large prospective studies are warranted to validate these results.

Endoscopic ultrasound‐guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study

“…We utilized a different LAMS, the Hot-Spaxus stent, which has been reported to have a high technical performance in EUS-GBD. [17][18][19][20][21] As in the previous studies, technical success was achieved in all patients, demonstrating GBD in this setting to be a very safe procedure, mostly ensured by skills previously acquired by endosonographers in the context of acute cholecystitis in high-risk surgical patients. Moreover, in the clinical scenario of the present study the GB is usually distended by the presence of DMBO and without inflammatory changes, such as thickened GB walls or peri-GB fluid/collection, thus making the drainage procedure easier than in the acute setting.…”

“…The cystic duct had to be patent on CT/MRI, which was subsequently rechecked during EUS done to perform EUS‐GBD that resulted in exclusion of three additional patients, leading to a total of 37 patients evaluated. We utilized a different LAMS, the Hot‐Spaxus stent, which has been reported to have a high technical performance in EUS‐GBD 17–21 . As in the previous studies, technical success was achieved in all patients, demonstrating GBD in this setting to be a very safe procedure, mostly ensured by skills previously acquired by endosonographers in the context of acute cholecystitis in high‐risk surgical patients.…”

Lumen-apposing metal stents for the treatment of pancreatic and peripancreatic fluid collections and bleeding risk: a propensity matched study

“…A second LAMS (Spaxus; Taewoong Medical Co., Gimpo, Republic of Korea) became available in 2016 and was recently incorporated into a device with electrocautery capabilities at its tip (Hot-Spaxus; Taewoong Medical Co.). The Spaxus stent has rounded edges and foldable flanges, allowing accommodative apposition between the stent and the cavity wall, which should theoretically reduce intracavity bleeding [10,11]. Available data on PFC drainage have reported bleeding rates of 5.1 %, with one case requiring angiographic embolization; however, the number of treated patients in the publication by Teoh et al [12] and in other small reports [13,14] is insufficient to draw any definitive conclusions.…”

“…The advent of another LAMS in 2016, the Spaxus stent, which has a different terminal end design, with rounded edges and flanges that fold back and conform to the surface of the intracavity wall of the PFC, could theoretically reduce the risk of intracavity bleeding [10,11]. To test this hypothesis, we collected data from 18 tertiary referral high volume endoscopy centers on a large number of patients with PFCs who underwent drainage with the Hot-Axios and Spaxus stents.…”

Lumen apposing metal stents for the treatment of pancreatic and peri-pancreatic fluid collection and bleeding risk: a propensity matched study

“…Methods This is a retrospective study in patients with PFC and treated by Axios and Spaxus (both cold and hot), in eighteen endoscopic referral centers 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 .…”