FEASIBILITY AND SAFETY OF A DEDICATED CAUTERY-ENHANCED TUBULAR SELF-EXPANDABLE METAL STENT FOR ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is an alternative for biliary drainage in patients with obstructive pancreatobiliary pathology when endoscopic retrograde cholangiography (ERCP) is not feasible. Despite its effectiveness, EUS-HGS is associated with a significant risk of adverse events. This study aimed to evaluate the feasibility and safety of a newly dedicated cautery-enhanced tubular self-expandable metal stent (SEMS) for EUS-HGS. PATIENTS AND METHODS: This multicenter prospective study included patients with malignant biliary obstruction who failed ERCP because of tumor infiltration or surgically-altered anatomy. A dedicated cautery-enhanced tubular SEMS was used for EUS-HGS. Technical and clinical success rates, procedure times, and adverse events were evaluated. RESULTS: Twenty patients underwent EUS-HGS with the dedicated stent and achieved technical and clinical success rates of 100 %, with no reported severe adverse events or mortality. The mean procedure time was 16 minutes. Recurrent biliary obstruction was observed in 5% of patients. CONCLUSIONS: Dedicated cautery-enhanced tubular SEMS for EUS-HGS can simplify the procedure and enhance its safety and efficacy. This innovation shows promise for improving patient outcomes, although further studies are needed to validate these findings in a broader patient population.

EUS vs. ERCP-guided primary drainage of inoperable distal malignant biliary obstruction: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Several randomized controlled trials (RCTs) compared endoscopic ultrasound-guided biliary drainage (EUS-BD) to endoscopic retrograde cholangiopancreatography (ERCP) as first-line interventions in distal malignant biliary obstruction (DMBO). We assessed the efficacy and safety of these two approaches. METHODS: A PubMed/Medline, Embase and Cochrane databases bibliographic search until 01/12/2023 was performed to identify RCTs comparing EUS-BD to ERCP for primary biliary drainage in inoperable patients with DMBO. Primary outcome was technical success. Secondary outcomes were clinical success, adverse events (AEs), mean procedure time, 1-year stent patency, and overall survival. Relative risk (RR) with 95% confidence interval (CI) were calculated using random-effect model. RESULTS: Five studies (519 patients) were included. The RR for pooled technical success in EUS-BD was 1.06 ([0.96-1.17]; P=0.27) and 1.02 [0.97-1.08]; P=0.45) for clinical success. 1-year stent patency was similar among the two groups (RR 1.15; [0.94-1.42], P=0.17), with lower reintervention in the EUS-BD group (RR 0.58; [0.37-0.9]; P=0.01). The RR of AEs rate was 0.85 [0.49-1.46]; P=0.55) and severe AEs of 0.97 [0.10-0.17]; P=0.98). On subgroup analysis, EUS-lumen apposing metal stents (LAMS) outperformed ERCP in term of technical success (RR 1.17; [1.01-1.35]; P=0.03). Procedure time was lower in EUS-BD (standardized mean difference -2.36 minutes; [-2.68 to -2.05]; P<0.001). CONCLUSIONS: EUS-BD showed a statistically significant lower re-intervention rate compared to ERCP, but with similar technical success rate, stent patency, clinical success rate and safety profile, while in the subgroup of EUS-LAMS, the technical success was better than ERCP Keywords: distal; biliary obstruction; efficacy; safety.

Endoscopic Ultrasonography-Guided Gallbladder Drainage.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as a popular alternative to percutaneous cholecystostomy and endoscopic transpapillary gallbladder drainage for patients suffering from acute calculous cholecystitis who are at high risk for surgery. Multiple cohorts, meta-analyses, and a randomized controlled trial have shown that EUS-GBD has lower rates of recurrent cholecystitis and unplanned reinterventions, while achieving similar technical and clinical success rates than transpapillary cystic duct stenting. The essential steps, precautions in performing EUS-GBD and long-term management will be discussed in this article.

Consensus statements on endoscopic ultrasound-guided tissue acquisition. Guidelines from the Asian Endoscopic Ultrasound Group.

OBJECTIVES: This consensus was developed by the Asian EUS Group (AEG), who aimed to formulate a set of practice guidelines addressing various aspects of endoscopic ultrasound-guided tissue acquisition (EUS-TA). METHODS: The AEG initiated the development of consensus statements and formed an expert panel comprising surgeons, gastroenterologists, and pathologists. Three online consensus meetings were conducted to consolidate the statements and votes. The statements were presented and discussed in the first two consensus meetings and revised according to comments. Final voting was conducted at a third consensus meeting. The Grading of Recommendations, Assessment, Development, and Evaluation system was adopted to define the strength of the recommendations and quality of evidence. RESULTS: A total of 20 clinical questions and statements regarding EUS-TA were formulated. The committee recommended that fine-needle biopsy (FNB) needles be preferred over conventional fine-needle aspiration (FNA) needles for EUS-TA of subepithelial lesions. For solid pancreatic masses, rapid on-site evaluation is not routinely recommended when FNB needles are used. For dedicated FNB needles, fork-tip and Franseen-tip needles have essentially equivalent performance. CONCLUSION: This consensus provides guidance for EUS-TA, thereby enhancing the quality of EUS-TA.

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

INTRODUCTION: Endoscopic ultrasound (EUS)-guided drainage of symptomatic pancreatic fluid collections (PFCs) using the Hot-Axios device has recently been associated with a significant risk of bleeding. This adverse event (AE) seems to occur less frequently with the use of a different device, the Spaxus stent. The aim of the current study was to compare the rates of bleeding between the two stents. METHODS: Patients admitted for treatment of PFCs by EUS plus lumen-apposing metal stent in 18 endoscopy referral centers between 10 July 2019 and 28 February 2022 were identified and their outcomes compared using a propensity-matching analysis. RESULTS: 363 patients were evaluated. After a 1-to-1 propensity score match, 264 patients were selected (132 per group). The technical and clinical success rates were comparable between the two groups. Significantly more bleeding requiring transfusion and/or intervention occurred in the Hot-Axios group than in the Spaxus group (6.8% vs. 1.5%; P = 0.03); stent type was a significant predictor of bleeding in both univariate and multivariate regression analyses (P = 0.03 and 0.04, respectively). Bleeding necessitating arterial embolization did not however differ significantly between the two groups (3.0% vs. 0%; P = 0.12). In addition, the Hot-Axios was associated with a significantly higher rate of overall AEs compared with the Spaxus stent (9.8% vs. 3.0%; P = 0.04). CONCLUSION: Our study showed that, in patients with PFCs, bleeding requiring transfusion and/or intervention occurred significantly more frequently with use of the Hot-Axios stent than with the Spaxus stent, although this was not the case for bleeding requiring embolization.

Partially covered versus uncovered pyloro-duodenal stents for unresectable malignant gastric outlet obstruction: Randomized controlled study.

OBJECTIVES: The aim of the current study was to compare the efficacy of partially covered duodenal stent (PCDS) vs. uncovered duodenal stent (UCDS) in patients suffering from unresectable primary malignant gastric outlet obstruction (GOO). METHODS: This was a prospective international randomized controlled study conducted in 10 high-volume institutions. Consecutive patients suffering from malignant GOO were recruited. The primary outcome measurement was the reintervention rate. Secondary outcomes included technical and clinical success, 30-day adverse events, 30-day mortality, causes of stent dysfunction, and the duration of stent patency. RESULTS: Between March 2017 and October 2020, 115 patients (59 PCDS, 56 UCDS) were recruited. The 1-year reintervention was not significantly different (PCDS vs. UDCS = 12/59, 20.3% vs. 14/56, 25%, P = 0.84). There was a trend to fewer patients with tumor ingrowth in the PCDS group (6/59 [10.2%]) vs. 13/56 [23.2%], P = 0.07). There were no significant differences in the technical success (100% vs. 100%, P = 1), clinical success (91.5% vs. 98.2%, P = 0.21), procedural time (21.5 [interquartile range [IQR] 17-30] vs. 20.0 [IQR 15-34.75], P = 0.62), hospital stay (4 [IQR 3-12] vs. 5 [IQR 3-8] days, P = 0.81), 30-day adverse events (18.6% vs. 14.3%, P = 0.62), or 30-day mortality (6.8% vs. 5.2%, P = 1.00). CONCLUSION: The use of PCDS was associated with a lower risk of tumor ingrowth but did not improve on reintervention rates or stent patency. Both kinds of stents could be used in this group of patients.

Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.

BACKGROUND: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting. METHODS: The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed. FINDINGS: Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08-0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related. INTERPRETATION: In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available. FUNDING: Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.

Mishaps with EUS-guided lumen-apposing metal stents in therapeutic pancreatic EUS: Management and prevention.

EUS-guided interventions have become widely accepted therapeutic management options for drainage of peripancreatic fluid collections. Apart from endosonographic skills, EUS interventions require knowledge of the endoscopic stenting techniques and familiarity with the available stents and deployment systems. Although generally safe and effective, technical failure of correct stent positioning or serious adverse events can occur, even in experts' hands. In this article, we address common and rare adverse events in transmural EUS-guided stenting, ways to prevent them, and management options when they occur. Knowing the risks of what can go wrong combined with clinical expertise, high levels of technical skills, and adequate training allows for the safe performance of EUS-guided drainage procedures. Discussing the procedural risks and their likelihood with the patient is a fundamental part of the consenting process.

A proof-of-concept study on endoscopic ultrasound-guided biopsy of detrusor muscle in porcine bladders.

Introduction: Conventionally, we rely on transurethral resection of bladder tumour (TURBT) for local staging of muscle-invasive bladder cancer (MIBC). However, the procedure is limited by its staging inaccuracy which may delay the definitive treatment of MIBC. Methods: We conducted a proof-of concept study on endoscopic ultrasound (EUS)-guided biopsy of detrusor muscle in porcine bladders. Five porcine bladders were used in this experiment. Upon EUS, four layers of tissue including the mucosa (hypoechoic), submucosa (hyperechoic), detrusor muscle (hypoechoic) and serosa (hyperechoic) could be identified. Results: A total of 37 EUS-guided biopsies were taken from 15 sites (three sites per bladder), and the mean number of biopsies taken from each site was 2.47±0.64. Among the 37 biopsies, 30 of them (81.1%) obtained detrusor muscle in the biopsy specimen. For the per biopsy site analysis, detrusor muscle was obtained in 73.3% if only one biopsy was taken, and 100% if two or more biopsies were taken from the same biopsy site. Overall, detrusor muscle was successfully obtained from all 15 biopsy sites (100%). No bladder perforation was observed throughout all biopsy processes. Conclusion: EUS-guided biopsy of the detrusor muscle could be performed during the initial cystoscopy session, thus expediting the histological diagnosis and subsequent treatment of MIBC.

The effect of Andrographis paniculata water extract on palliative management of metastatic esophageal squamous cell carcinoma-A phase II clinical trial.

Patients with metastatic esophageal squamous cell carcinoma (ESCC) have a grave prognosis with limited life expectancy. Here, a phase II clinical trial was conducted to investigate the effect of Andrographis paniculata (AP) on the palliative care of patients with metastatic ESCC. Patients with metastatic or locally advanced ESCC deemed unfit for surgery, and who have already completed palliative chemotherapy or chemoradiotherapy or are not fit for these treatments, were recruited. These patients were prescribed AP concentrated granules for 4 months. They also received clinical and quality of life assessments for clinical response, as well as positron emission tomography-computed tomography at 3 and 6 months after AP treatment for the assessment of tumor volume. Furthermore, the change in gut microbiota composition after AP treatment was studied. From the results, among the 30 recruited patients, 10 completed the entire course of AP treatment, while 20 received partial AP treatment. Patients who completed the AP treatment achieved significantly longer overall survival periods with the maintenance of the quality of life during the survival period when compared to those who could not complete AP treatment. The treatment effect of AP also contributed to the shift of the overall structure of gut microbiota for ESCC patients towards those of healthy individuals. The significance of this study is the establishment of AP as a safe and effective palliative treatment for patients with squamous cell carcinoma of the esophagus. To the best of our knowledge, this is the first clinical trial of AP water extract in esophageal cancer patients demonstrating its new medicinal use.

EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial).

BACKGROUND & AIMS: Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. METHODS: This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. RESULTS: Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P = .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P = .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P = 1) and 30-day mortality (P = .53) were similar. CONCLUSION: Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.

Endoscopic full-thickness resection (EFTR) compared to submucosal tunnel endoscopic resection (STER) for treatment of gastric gastrointestinal stromal tumors.

Background and study aims Submucosal tunnel endoscopic resection (STER) is being increasingly performed for treatment of gastric gastrointestinal stromal tumor (GIST), while STER has been limited by close dissection within tunnel and risking breach of tumor capsule. Endoscopic full-thickness resection (EFTR) allows resection of GIST with margins to prevent recurrence. This study aimed to compare EFTR against STER for treatment of gastric GIST. Patients and methods We retrospectively reviewed clinical outcomes of patients with gastric GIST who received either STER or EFTR. Patients with gastric GISTs < than 4 cm were included. Clinical outcomes including baseline demographics, perioperative and oncological outcomes were compared between the two groups. Results From 2013 to 2019, 46 patients with gastric GISTs were treated with endoscopic resection, 26 received EFTR and 20 received STER. Most of the GISTs were in the proximal stomach. There was no difference in operative time (94.9 vs 84.9 mins; P  = 0.401), while endoscopic suturing was applied more for closure after EFTR ( P  < 0.0001). Patients after STER had earlier resumption of diet and shorter hospital stay while there was no difference in adverse event rate between two groups. The en-bloc resection rate for EFTR was significantly higher than for STER (100 % vs 80 %; P  = 0.029), while there was no difference in the local recurrence. Conclusions This study demonstrated that although patients who received EFTR had longer hospital stays and slower resumption of diet compared to those who underwent STER, EFTR achieved a significantly higher rate of en-bloc resection compared to STER for treatment of gastric GIST.

Techniques and Outcomes of Endoscopic Ultrasound Guided-Pancreatic Duct Drainage (EUS- PDD).

Endoscopic ultrasound guided-pancreatic duct drainage (EUS- PDD) is one of the most technically challenging procedures for the interventional endoscopist. The most common indications for EUS- PDD are patients with main pancreatic duct obstruction who have failed conventional endoscopic retrograde pancreatography (ERP) drainage or those with surgically altered anatomy. EUS- PDD can be performed via two approaches: the EUS-rendezvous (EUS- RV) or the EUS-transmural drainage (TMD) techniques. The purpose of this review is to provide an updated review of the techniques and equipment available for EUS- PDD and the outcomes of EUS- PDD reported in the literature. Recent developments and future directions surrounding the procedure will also be discussed.

Droplet nuclei are generated during colonoscopy and are decreased by the use of carbon dioxide and water immersion technique.

OBJECTIVES: The COVID-19 pandemic has raised concerns on whether colonoscopies (CS) carry a transmission risk. The aim was to determine whether CS are aerosol-generating procedures. METHODS: This was a prospective observational trial including all patients undergoing CS at the Prince of Wales Hospital from 1 June to 31 July 2020. Three particle counters were placed 10 cm from each patient's anus and near the mouth of endoscopists and nurses. The particle counter recorded the number of particles of size 0.3, 0.5, 0.7, 1, 5, and 10 µm. Patient demographics, seniority of endoscopists, use of CO2 and water immersion technique, and air particle count (particles/cubic foot, dCF) were recorded. Multilevel modeling was used to test all the hypotheses with a post-hoc analysis. RESULTS: A total of 117 patients were recruited. During CS, the level of 5 µm and 10 µm were significantly higher than the baseline period (P = 0.002). Procedures performed by trainees had a higher level of aerosols when compared to specialists (0.3 µm, P < 0.001; 0.5 µm and 0.7 µm, P < 0.001). The use of CO2 and water immersion techniques had significantly lower aerosols generated when compared to air (CO2 : 0.3, 0.5, and 0.7 µm: P < 0.001; water immersion: 0.3 µm: P = 0.048; 0.7 µm: P = 0.03). There were no significant increases in any particle sizes during the procedure at the endoscopists' and nurses' mouth. However, 8/117 (6.83%) particle count tracings showed a simultaneous surge of all particle sizes at the patient's anus and endoscopists' and nurses' level during rectal extubation. CONCLUSION: Colonoscopy generates droplet nuclei especially during rectal extubation. The use of CO2 and water immersion techniques may mitigate these risks.