Safety, efficacy, and clinical utility of the 5.1-mm debridement catheter for treatment of walled-off pancreatic necrosis (with video).

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) is a recommended strategy for treatment of walled-off necrosis (WON). DEN uses a variety of devices including the EndoRotor (Interscope, Inc, Northbridge, Mass, USA) debridement catheter. Recently, a 5.1-mm EndoRotor with an increased chamber size and rate of tissue removal was introduced. The aim of this study was to assess the efficacy and safety of this device. METHODS: A multicenter cohort study was conducted at 8 institutions including patients who underwent DEN with the 5.1-mm EndoRotor. The primary outcome was the number of DEN sessions needed for WON resolution. Secondary outcomes were the average percentage of reduction in solid WON debris and decrease in WON area per session, total time spent performing EndoRotor therapy for WON resolution, and adverse events (AEs). RESULTS: Sixty-four procedures in 41 patients were included. For patients in which the 5.1-mm EndoRotor catheter was the sole therapeutic modality, an average of 1.6 DEN sessions resulted in WON resolution with an average cumulative time of 85.5 minutes. Of the 21 procedures with data regarding percentage of solid debris, the average reduction was 85% ± 23% per session. Of the 19 procedures with data regarding WON area, the mean area significantly decreased from 97.6 ± 72.0 cm2 to 27.1 ± 35.5 cm2 (P < .001) per session. AEs included 2 intraprocedural dislodgements of lumen-apposing metal stents managed endoscopically and 3 perforations, none of which was related to the EndoRotor. Bleeding was reported in 7 cases, in which none required embolic or surgical therapy and 2 required blood transfusions. CONCLUSIONS: This is the first multicenter retrospective study to investigate the efficacy and safety of the 5.1-mm EndoRotor catheter for WON. Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single-session reduction in solid debris and a 70% single-session decrease in WON area with minimal AEs.

Comprehensive analysis of adverse events associated with transmural use of LAMS in patients with liver cirrhosis: International multicenter study.

Background and study aims Endoscopic ultrasound (EUS)-guided transmural (TM) deployment of lumen-apposing metal stents (LAMS) is considered relatively safe in non-cirrhotic patients and is cautiously offered to cirrhotic patients. Patients and methods This was a retrospective, multicenter, international matched case-control study to study the safety of EUS-guided TM deployment of LAMS in cirrhotic patients. Results Forty-three cirrhotic patients with model for end-stage liver disease score 12.5 ± 5, with 23 having ascites and 16 with varices underwent EUS-guided TM LAMS deployment, including 19 for pancreatic fluid collection (PFC) drainage, 13 gallbladder drainage, six for endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP), three for EDGI, one for endoscopic ultrasound-directed transenteric ERCP, and one postsurgical collection drainage. Technical failure occurred in one LAMS for PFC drainage. Clinical failure was encountered in another PFC. Nine adverse events (AEs) occurred. The most common AE was LAMS migration (3), followed by non-bleeding mucosal erosion (2), delayed bleeding (2), sepsis (1), and anesthesia-related complication (pulseless electrical activity) (1). Most AEs were graded as mild (6), followed by severe (2), and moderate (1); the majority were managed conservatively. On univariable comparison, risk of AE was higher when using a 20 × 10 mm LAMS and the absence of through-the-LAMS plastic stent(s). Conditional logistic regression of matched case-control patients did not show any association between potential predicting factors and occurrence of AEs. Conclusions Our study demonstrated that mainly in patients with Child-Pugh scores A and B cirrhosis and despite the presence of mild-to-moderate ascites in over half of cases, the majority of AEs were mild and could be managed conservatively. Further studies are warranted to verify the safety of LAMS in cirrhotic patients.

Feasibility and safety of peroral endoscopic myotomy with fundoplication in patients with achalasia: a systematic review and meta-analysis.

Background: Achalasia can cause disabling symptoms that may substantially impair the quality of life. Peroral endoscopic myotomy (POEM) has shown promising results in the management of achalasia. In this meta-analysis we have evaluated the feasibility and safety of single-session POEM with fundoplication (POEM+F) in patients with achalasia. Methods: We reviewed several databases from inception to July 08, 2022, to identify studies evaluating the feasibility and/or safety of single-session POEM+F for patients with achalasia. Our outcomes of interest included the technical success of POEM+F, adverse events, esophagitis and wrap integrity on follow-up upper endoscopy, total procedure time, and fundoplication time. Pooled rates with 95% confidence intervals (CI) for outcomes were calculated using a random effect model. Heterogeneity was assessed using the I 2 statistic. Results: We included 4 studies with 90 patients. Pooled rates (95%CI) of technical success and adverse events were 92% (83-96%) and 5% (2-11%), respectively. Pooled rates (95%CI) of esophagitis and wrap integrity on follow-up upper endoscopy were 18% (11-30%) and 85% (43-98%) respectively. Pooled mean procedure time and fundoplication time were 113.2 (98.7-127.6) and 55.3 (43.7-66.8) min, respectively. Conclusions: This meta-analysis demonstrates the feasibility and safety of POEM+F in patients with achalasia. More studies with long-term follow up are required to further validate these findings.