Accurate and safe diagnosis and treatment of neoplastic biliary lesions using a novel 9F and 11F digital single-operator cholangioscope.

Background and study aims Digital single-operator cholangioscopy (DSOC) allows the diagnosis of biliary duct disorders and treatment for complicated stones. However, these technologies have limitations such as the size of the probe and working channel, excessive cost, and low image resolution. Recently, a novel DSOC system (eyeMAX, Micro-Tech, Nanjing, China) was developed to address these limitations. We aimed to evaluate the usefulness and safety of a novel 9F and 11F DSOC system in terms of neoplastic diagnostic accuracy based on visual examination, ability to evaluate tumor extension and to achieve complete biliary stone clearance, and procedure-related adverse events (AEs). Patients and methods Data from ≥ 18-year-old patients who underwent DSOC from July 2021 to April 2022 were retrospectively recovered and divided into a diagnostic and a therapeutic cohort. Results A total of 80 patients were included. In the diagnostic cohort (n = 49/80), neovascularity was identified in 26 of 49 patients (46.9%). Biopsy was performed in 65.3% patients with adequate tissue sample obtained in 96.8% of cases. Biopsy confirmed neoplasia in 23 of 32 cases. DSOC visual impression achieved 91.6% sensitivity and 87.5% specificity in diagnosing neoplasms. In the therapeutic cohort (n = 43/80), 26 of 43 patients required lithotripsy alone. Total stone removal was achieved in 71% patients in the first session. Neither early nor late AEs were documented in either the diagnostic or therapeutic cohort. Conclusions The novel DSOC device has excellent diagnostic accuracy in distinguishing neoplastic biliary lesions as well as therapeutic benefits in the context of total stone removal, with no documented AEs.

International Consensus Recommendations for Safe Use of LAMS for On- and Off-Label Indications Using a Modified Delphi Process.

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Utilization of an overtube for placement of a lumen-apposing metal stent for removal of a capsule endoscope retained proximal to an ileal stricture.

Video 1Narration of case and demonstration of overture-mediated lumen-apposing metal stent placement for removal of retained capsule endoscopy.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

1: ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2: ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3: ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4: ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5: ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6: ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7: ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8: ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) over percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction when local expertise is available.Strong recommendation, moderate quality evidence. 2: ESGE suggests EUS-BD with hepaticogastrostomy only for malignant inoperable hilar biliary obstruction with a dilated left hepatic duct when inadequately drained by ERCP and/or PTBD in high volume expert centers.Weak recommendation, moderate quality evidence. 3: ESGE recommends that EUS-guided pancreatic duct (PD) drainage should only be considered in symptomatic patients with an obstructed PD when retrograde endoscopic intervention fails or is not possible.Strong recommendation, low quality evidence. 4: ESGE recommends rendezvous EUS techniques over transmural PD drainage in patients with favorable anatomy owing to its lower rate of adverse events.Strong recommendation, low quality evidence. 5: ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.Strong recommendation, high quality of evidence. 6: ESGE recommends EUS-guided gastroenterostomy (EUS-GE), in an expert setting, for malignant gastric outlet obstruction, as an alternative to enteral stenting or surgery.Strong recommendation, low quality evidence. 7: ESGE recommends that EUS-GE may be considered in the management of afferent loop syndrome, especially in the setting of malignancy or in poor surgical candidates. Strong recommendation, low quality evidence. 8: ESGE suggests that endoscopic ultrasound-directed transgastric ERCP (EDGE) can be offered, in expert centers, to patients with a Roux-en-Y gastric bypass following multidisciplinary decision-making, with the aim of overcoming the invasiveness of laparoscopy-assisted ERCP and the limitations of enteroscopy-assisted ERCP.Weak recommendation, low quality evidence.

Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).

Endoscopic ultrasound-guided gastroenterostomy using an oroenteric catheter-assisted technique: a retrospective analysis.

BACKGROUND : This study evaluated an oroenteric catheter (OEC)-assisted technique to distend the enteric loop for endoscopic ultrasound-guided gastroenterostomy (EUS-GE) in patients with gastric outlet obstruction (GOO). METHODS : Patient outcomes were reviewed. Proximal enteric loops were filled with water via an OEC (7 Fr or 8 Fr), providing a target for EUS-GE using a lumen-apposing metal stent (15-mm caliber). Clinical success was defined as toleration of a non-liquid diet by Day 3. RESULTS : 42 patients (mean age 73.1 [SEM 2.8] years; 23 male) underwent EUS-GE for malignant (n = 37) and benign (n = 5) duodenal strictures. EUS-GE creation was successful in 41/42 (98 %), with mean procedure time of 36 (SEM 3) minutes and no serious complications. Clinical success was achieved in 39/42 (93 %) at 5.7 (SEM 2.6) months' follow-up. Of 14 patients who died, 13 (93 %) maintained oral intake until death. EUS-GE provided good symptom relief in all 28 surviving patients until follow-up. CONCLUSIONS : OEC-assisted EUS-GE provided satisfactory relief of GOO symptoms, with high technical success (98 %) and no serious complications.

International, multicenter retrospective trial comparing the efficacy and safety of bi-flanged versus lumen-apposing metal stents for endoscopic drainage of walled-off pancreatic necrosis.

BACKGROUND: To compare fully covered bi-flanged metal stents (BFMS) and lumen-apposing metal stents (LAMS) for endoscopic ultrasound (EUS)-guided drainage/debridement of pancreatic walled-off necrosis (WON). METHODS: Patients with WON managed by EUS-guided therapy were divided into those who underwent: 1) drainage using BFMS; and 2) drainage using LAMS and scheduled direct endoscopic necrosectomy (DEN). Clinical success (resolution of the WON), technical success (successful stent placement), and adverse events (AEs) were evaluated. RESULTS: 387 patients underwent WON endoscopic drainage, 205 using BFMS and 182 using LAMS. The clinical success in the BFMS or LAMS groups were similar (197 [96.1%] vs. 174 [95.6%]; P=0.81). Median number of procedures required for WON resolution was significantly lower in BFMS compared to LAMS (2 vs. 3, P<0.001). Technical success for stent placement was similar in BFMS and LAMS groups (203 [99%] vs. 180 [99%], P=0.90). Procedure-related AEs were similar in the BFMS and LAMS groups (19 [9.3%] vs. 20 [10.9%], P=0.61). Stent dysfunction with occluding debris was higher in the BFMS group compared to LAMS group (21 [10.2 %] vs. 11 [5.9%], P=0.04). The migration rate was higher in the BFMS group than in the LAMS group (15 [7.3%] vs. 3 [1.6%]; P<0.001). DEN was required in 23 [11.2%] patients in the BFMS group after lack of WON resolution by conservative means. CONCLUSION: BFMS with a "step-up approach" and LAMS with scheduled DEN are both safe and effective for EUS-guided drainage/debridement of WON.

Safety and efficacy of EUS-guided coil and glue injection for the primary prophylaxis of gastric variceal hemorrhage.

BACKGROUND AND AIMS: Gastric variceal bleeding (GVB) is associated with high morbidity and mortality. EUS-guided coil and cyanoacrylate (CYA) injection (EUS-CCI) has been shown to be an effective therapy in acute bleeding and secondary prophylaxis; however, there is a paucity of data on primary prophylaxis. METHODS: In this single-center observational study, adult patients with high-risk gastric varices (GV; size >10 mm or cherry red spot) without prior bleeding underwent EUS-CCI for the primary prophylaxis of GVB between June 2009 and December 2019. The primary outcome was post-treatment GVB. RESULTS: Eighty patients with a mean variceal size of 22.5 ± 9.4 mm and a mean length of follow-up of 3.0 ± 2.4 years were included. The etiology of portal hypertension was cirrhosis in 71 patients (88.7%) and noncirrhotic in 9 (11.3). The mean model for end-stage liver disease score was 12.3 ± 3.7 in patients with cirrhosis. The mean coil number was 1.5 (range, 1-3) and mean glue volume injected 2 mL (range, .5-5). Technical success was achieved in 100%, 96.7% had EUS confirmation of GV obliteration, and 67.7% were obliterated with 1 treatment session. Post-treatment GVB occurred in 2 patients (2.5%) and adverse events in 4 (4.9%). No deaths related to GVB occurred, and emergent transjugular intrahepatic shunts were not needed during the follow-up period. CONCLUSIONS: In patients with high-risk GV, EUS-CCI for primary prophylaxis is highly effective at preventing GVB with a low rate of adverse events. Primary prophylaxis of high-risk GV with coil and CYA glue injection should be considered in centers with the appropriate expertise.

Endoscopic ultrasound-guided gastroenterostomy versus open surgical gastrojejunostomy: clinical outcomes and cost effectiveness analysis.

BACKGROUND: Early data suggests that endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a safe and efficacious option for gastric outlet obstruction (GOO). However, there is a scarcity of data comparing outcomes with open gastrojejunostomy (OGJ). METHODS: Single-center retrospective cohort study of adult patients hospitalized with GOO who underwent EUS-GE or OGJ between January 1, 2014 and February 28, 2020. Primary outcomes were technical and clinical success. RESULTS: Sixty-six patients were included of which 40 (60.0%) underwent EUS-GE and 26 (40.0%) underwent OGJ. Baseline characteristics were similar with respect to age (70.5 vs 69.7, p = 0.81), sex (42.5% vs 42.3% female, p = 0.99), median length of follow-up (98.0 vs 166.5 days, p = 0.8), prior failed intervention for GOO (22.5% vs 26.9%, p = 0.68), and the presence of altered anatomy (12.5% vs 30.8%, p = 0.07) between EUS-GE and OGJ, respectively. Technical success was achieved in 37 (92.5%) of EUS-GE and 26 (100%) of OGJ patients (p = 0.15). EUS-GE was associated with faster resumption of oral intake (1.3 vs 4.7 days, p < 0.001) and shorter length of stay (5 vs 14.5 days, p < 0.001). There were no significant differences in symptom recurrence (17.5% vs 19.2%, HR 1.85, CI 0.52-6.65, p = 0.34), reintervention (20% vs 11.5%, HR 0.82, CI 0.22-3.15, p = 0.78), death within 30 days (12.5% vs 3.8%, HR 0.80, CI 0.09-6.85, p = 0.84), or 30-day readmission (17.5% vs 24.1%, HR 1.69, CI 0.53-5.41, p = 0.37) between EUS-GE and OGJ, respectively. EUS-GE patients initiated chemotherapy sooner (17.7 vs 31.3 days, p = 0.033) and had lower overall costs as compared to OGJ ($49,387 vs $124,192, p < 0.001). CONCLUSION: There were no significant differences in technical or clinical success, symptom recurrence, reintervention, 30-day readmission, or 30-day mortality between EUS-GE and OGJ. EUS-GE patients experienced shorter delays to resumption of oral intake and chemotherapy, had shorter lengths of stay, and reduced hospital costs. Further prospective comparative studies are warranted to verify our results.

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

Underwater vs conventional endoscopic mucosal resection in the management of colorectal polyps: a systematic review and meta-analysis.

Background Recently, underwater endoscopic mucosal resection (UEMR) has shown promising results in the management of colorectal polyps. Some studies have shown better outcomes compared to conventional endoscopic mucosal resection (EMR). We conducted this systematic review and meta-analysis to compare UEMR and EMR in the management of colorectal polyps. Methods We searched several databases from inception to November 2019 to identify studies comparing UEMR and EMR. Outcomes assessed included rates of en bloc resection, complete macroscopic resection, recurrent/residual polyps on follow-up colonoscopy, complete resection confirmed by histology and adverse events. Pooled risk ratios (RR) with 95 % confidence interval were calculated using a fixed effect model. Heterogeneity was assessed by I 2 statistic. Funnel plots and Egger's test were used to assess publication bias. We used the Newcastle-Ottawa scale (NOS) for assessment of quality of observational studies, and the Cochrane tool for assessing risk of bias for RCTs Results Seven studies with 1291 patients were included; two were randomized controlled trials and five were observational. UEMR demonstrated statistically significantly better efficacy in rates of en bloc resection, pooled RR 1.16 (1.08, 1.26), complete macroscopic resection, pooled RR 1.28 (1.18, 1.39), recurrent/residual polyps; pooled RR 0.26 (0.12, 0.56) and complete resection confirmed by histology; pooled RR 0.75 (0.57, 0.98). There was no significant difference in adverse events (AEs); pooled RR 0.68 (0.44, 1.05). Conclusions This meta-analysis found statistically significantly better rates of en bloc resection, complete macroscopic resection, and lower risk of recurrent/residual polyps with UEMR compared to EMR. We found no significant difference in AEs between the two techniques.

Covid-19 pandemic impact on colonoscopy service and suggestions for managing recovery.

Background and aim As the post-peak phase of the epidemic is approaching, there is an urgent need of an action plan to help resume endoscopy activity. To manage the Covid-19 pandemic-imposed backlog of postponed colonoscopy examinations, an efficient approach is needed. The practice of on-demand sedation with benzodiazepines and/or opiates will allow most patients to complete a water-aided examination with minimal or no sedation. Other methods reported to minimize patient discomfort during colonoscopy can be used, in addition to water-aided techniques. Unsedated or minimally sedated patients who do not require recovery or require a shorter one allow rapid turnaround. The practice obviates the need for assistance with deep sedation from anesthesiologists, who may be in short supply. Trainee education in water-aided colonoscopy has been demonstrated to confer benefits. This review provides some insights into the impact of Covid-19 on endoscopy services, challenges ahead, and possible solutions to help recovery of colonoscopy work and training.

Effectiveness of combination endoscopic therapy for colonic anastomotic leaks.

BACKGROUND: Colonic anastomotic leaks are associated with significant morbidity and mortality. Whereas small case series suggest that fully covered self-expandable metal stents (FCSEMS) are effective, no larger studies have examined the impact of combination endoscopic therapy on colonic anastomotic leaks. METHODS: Our retrospective cohort study reviewed 51 patients undergoing endoscopic therapy for colonic anastomotic leaks between 2011 and 2018. Patients receiving combination therapy involving FCSEMS plus local closure (n = 24) were compared with patients receiving FCSEMS alone (n = 18) or endoscopic suturing alone (n = 9). The primary outcomes were technical and clinical success (resolution of leak, removal of percutaneous drains, avoidance of surgical reoperation, and reversal of temporary diversion). RESULTS: Clinical success was achieved in 55 % of patients. Clinical success was achieved in 18/24 patients (75 %) with combination therapy compared with 6/18 patients receiving FCSEMS alone (33 %, adjusted risk ratio [RR] 2.16, 95 % confidence interval [CI] 1.10 - 4.24; P = 0.02) and 4 /9 patients undergoing endoscopic suturing alone (44 %, RR 1.91, 95 %CI 0.84 - 4.31; P = 0.10). Stent migration occurred in 40 % of patients. CONCLUSIONS: This large series demonstrates that combination therapy was associated with a higher rate of clinical success, and future prospective studies are warranted.