Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial.

BACKGROUND & AIMS: Endoscopic transpapillary gallbladder stenting (ETGS) has been proposed as one of the adjunctive treatments, apart from antibiotics, before surgery in patients with acute cholecystitis whose cholecystectomy could not be performed or was deferred. Currently, there are no comparative data on the outcomes of ETGS in those who receive and do not receive ETGS. We aimed to compare the rates of recurrent cholecystitis at 3 and 6 months in these 2 groups. METHODS: Between 2020 and 2023, eligible acute calculous cholecystitis patients with a high probability of common bile duct stone, who were surgical candidates but could not have an early cholecystectomy during COVID-19 surgical lockdown, were randomized into groups A (received ETGS) and B (did not receive ETGS). A definitive cholecystectomy was performed at 3 months or later in both groups. RESULTS: A total of 120 eligible patients were randomized into group A (n = 60) and group B (n = 60). In group A, technical and clinical success rates were 90% (54 of 60) and 100% (54 of 54), respectively. Based on intention-to-treat analysis, group A had a significantly lower rate of recurrence than group B at 3 months (0% [0 of 60] vs 18.3% [11 of 60]; P = .001). At 3-6 months, group A showed a nonsignificantly lower rate of recurrent cholecystitis compared to group B (0% [0 of 32] vs 10% [3 of 30]; P = .11). CONCLUSIONS: ETGS could prevent recurrent cholecystitis in acute cholecystitis patients with common bile duct stone whose cholecystectomy was deferred for 3 months. In those who did not receive ETGS, the majority of recurrences occurred within 3 months. (Thaiclinicaltrials.org, Number TCTR20200913001).

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.

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.

Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis.

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS: This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS: Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION: MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

Intermediate- to long-term outcomes of endoscopic transpapillary gallbladder stenting in patients with gallstone-related disease: a 10-year single-center experience.

BACKGROUND: Endoscopic transpapillary gallbladder stenting (ETGS) can be a bridging therapy to elective cholecystectomy or a permanent gallbladder drainage method in patients with symptomatic gallbladder disease who are awaiting cholecystectomy or are unfit for surgery, respectively. We evaluated the intermediate- to long-term outcomes of ETGS in these groups. METHODS: We retrospectively reviewed 234 patients (acute cholecystitis = 147), who were unfit for surgery (n = 50) or had deferred cholecystectomy (n = 184) and who underwent ETGS between 2012 and 2021. A 7-Fr, 15-cm, double-pigtail plastic stent was placed for ETGS without scheduled stent exchange. Biliary event-free rates (i. e. cholecystitis and cholangitis) were determined at 6 months, 1 year, and ≥ 2 years. RESULTS: Technical and clinical success rates were 84.6 % (198/234) and 97.4 % (193/198), respectively. Kaplan-Meier analysis (n = 193) showed a biliary event-free rate of 99 % (95 %CI 0.95-1.00) at 6 months, 92 % (95 %CI 0.87-0.97) at 1 year, and 76 % (95 %CI 0.65-0.93) at ≥ 2 years, during a median follow-up period of 564 days (range 200-3001 days). CONCLUSIONS: ETGS is an effective biliary drainage method that should be considered in selected cases with common bile duct stone where cholecystectomy could not be performed or was deferred. The biliary event-free rates of ≥ 76 % up to ≥ 2 years further support the use of ETGS in these patient groups.

Morphology of the major duodenal papilla for the selection of advanced cannulation techniques in difficult biliary cannulation.

BACKGROUND: Morphology of the major duodenal papilla (MDP) influences the outcome of standard biliary cannulation. However, those data on advanced cannulation techniques are scarce. We aimed to study the impact of MDP morphology on the outcome of both standard and advanced cannulation methods. METHODS: Images of naïve papilla were retrospectively reviewed and independently classified into 4 types (1: classic appearance, 2: small, 3: bulging, and 4: ridged papillae). All cannulation was started with guidewire cannulation. After failure, advanced cannulation including double guidewire (DG) and/or precut sphincterotomy (PS) was performed. Outcomes including success rate and complications were analyzed. RESULTS: A total 805 naïve papilla were included. The overall advanced cannulation rate was 23.2%. The MPD type 2 (OR 1.8, 95% CI 1.8-2.9) and type 4 (OR 2.1, 95% CI 1.1-3.8) required advanced cannulation technique at a higher rate than type 1. Type 3 significantly needed a higher proportion of PS when compared with type 1 (59.09% vs 27.03%, OR 3.90, 95% CI 1.51-10.06). Overall post-ERCP pancreatitis (PEP) was 8% and was not different among MDP types. PEP was significantly increased in difficult cannulation group (15.38% vs 5.71%, p-value < 0.001). Multivariate analysis demonstrated that DG independently increased risk of PEP (OR 3.6, 95% CI 2.0-6.6). CONCLUSIONS: MDP type 2 and type 4 were related to difficult cannulation. Although DG and PS can be used as advanced cannulation in all types, DG carries risk of PEP and PS may be preferred over DG in MDP type 3.

Accuracy and agreement of a large panel of endosonographers for endomicroscopy-guided virtual biopsy of pancreatic cystic lesions.

BACKGROUND: Although emerging data evidences that EUS-guided needle-based confocal laser endomicroscopy (nCLE) accurately diagnoses pancreatic cystic lesions (PCLs), there are a lack of interobserver agreement (IOA) studies utilizing reference histopathological diagnosis and for specific PCL subtypes. Hence, we sought to assess the IOA, intra-observer reliability (IOR), and diagnostic performance of EUS-nCLE using a large cohort of patients with histopathological diagnosis amongst a broad panel of international observers. METHODS: EUS-nCLE videos (n = 76) of subjects with PCLs [intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystadenoma (SCA), pseudocyst, and cystic-neuroendocrine tumors/solid pseudopapillary neoplasm (cystic-NET/SPN)], simulating clinical prevalence rates were obtained from 3 prospective studies. An international panel of 13 endosonographers with nCLE experience, blinded to all PCL data, evaluated the video library twice with a two-week washout for PCL differentiation (mucinous vs. non-mucinous) and subtype diagnosis. RESULTS: The IOA (κ = 0.82, 95% CI 0.77-0.87) and IOR (κ = 0.82, 95% CI 0.78-0.85) were "almost perfect" to differentiate mucinous vs. non-mucinous PCLs. For PCL subtype, IOA was highest for SCA (almost perfect; κ = 0.85), followed by IPMN (substantial, κ = 0.72), and cystic-NET/SPN (substantial, κ = 0.73). The IOA was moderate for MCN (κ = 0.47), and pseudocyst (κ = 0.57). Compared to histopathology, observers differentiated mucinous vs. non-mucinous PCLs with high accuracy (94.8%, 95% CI 93.3-96.1). For detecting specific PCLs subtypes, EUS-nCLE was highly accurate in diagnosing non-mucinous cysts (SCA: 98%; cystic-NET/SPN: 96%; pseudocyst: 96%) and slightly less accurate for mucinous lesions (IPMN: 86%; MCN: 84%). CONCLUSION: Diagnosis of PCLs by EUS-nCLE guided virtual biopsy is very accurate and reliable for the most prevalent pancreatic cysts in clinical practice.

Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared with duodenoscopes with fixed distal caps: a randomized trial.

BACKGROUND AND AIMS: Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD). METHODS: Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing. RESULTS: After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively). CONCLUSIONS: After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

A comparison of the antegrade core trap and reverse bevel needles for EUS-guided fine-needle biopsy sampling of liver mass: a prospective randomized cross over study.

BACKGROUND: Data on the use of EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) for pathology is limited. METHODS: To prove superiority of the diagnostic rate of the newly designed modified Menghini-type needle with a beveled side-slot near the needle tip with slot cutting edge directed 20-gauge antegrade bevel (group A) over the original 22-gauge reverse bevel (group B) for EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) in a prospective crossover randomized controlled trial. RESULTS: The overall diagnostic accuracy rate of the 52 passes was 86.5% (45/52) and of group A versus B were 88.5% (23/26) versus 84.6% (22/26), respectively, p = 0.858. Tissue adequacy levels of both groups were not significantly different (grade A: B: C = 18:6:2 versus 16:7:3), p = 0.839). Grading of blood contamination of both groups was not significantly different. However, it was found that the group-A needles could biopsy tissue of significantly longer length than that of the group B; 1.3 cm (SD = 0.76) versus 0.8 cm (SD = 0.54); p = 0.007. CONCLUSION: The use of EUS-FNB of SLM is highly effective with similar levels of efficacy and number of adverse events between both types of needles. THE TRIAL REGISTRATION NUMBER: Thai Clinical Trial Registration No. TCTR2018081002.

Consensus guidelines on the role of cholangioscopy to diagnose indeterminate biliary stricture.

BACKGROUND: Indeterminate strictures pose a therapeutic dilemma. In recent years, cholangioscopy has evolved and the availability of cholangioscopy has increased. However, the position of cholangioscopy in the diagnostic algorithm to diagnose malignancy have not been well established. We aim to develop a consensus statement regarding the clinical role of cholangioscopy in the diagnosis of indeterminate biliary strictures. METHODS: The international experts reviewed the evidence and modified the statements using a three-step modified Delphi method. Each statement achieves consensus when it has at least 80% agreement. RESULTS: Nine final statements were formulated. An indeterminate biliary stricture is defined as that of uncertain etiology under imaging or tissue diagnosis. When available, cholangioscopic assessment and guided biopsy during the first round of ERCP may reduce the need to perform multiple procedures. Cholangioscopy are helpful in diagnosing malignant biliary strictures by both direct visualization and targeted biopsy. The absence of disease progression for at least 6 months is supportive of non-malignant etiology. Direct per-oral cholangioscopy provides the largest accessory channel, better image definition, with image enhancement but is technically demanding. Image enhancement during cholangioscopy may increase the diagnostic sensitivity of visual impression of malignant biliary strictures. Cholangioscopic imaging characteristics including tumor vessels, papillary projection, nodular or polypoid mass, and infiltrative lesions are highly suggestive for neoplastic/malignant biliary disease. The risk of cholangioscopy related cholangitis is higher than in standard ERCP, necessitating prophylactic antibiotics and ensuring adequate biliary drainage. Per-oral cholangioscopy may not be the modality of choice in the evaluation of distal biliary strictures due to inherent technical difficulties. CONCLUSION: Evidence supports that cholangioscopy has an adjunct role to abdominal imaging and ERCP tissue acquisition in order to evaluate and diagnose indeterminate biliary strictures.

ERCP plus endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage for malignant hilar biliary obstruction: a multicenter observational open-label study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) may not provide complete biliary drainage in patients with Bismuth III/IV malignant hilar biliary obstruction (MHBO). Complete biliary drainage is accomplished by adding percutaneous transhepatic biliary drainage (PTBD). We prospectively compared recurrent biliary obstruction (RBO) rates between combined ERCP and endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. bilateral PTBD. METHODS: Patients with MHBO undergoing endoscopic procedures (group A) were compared with those undergoing bilateral PTBD (group B). The primary outcome was the 3-month RBO rate. RESULTS: 36 patients were recruited into groups A (n = 19) and B (n = 17). Rates of technical and clinical success, and complications of group A vs. B were 84.2 % (16/19) vs. 100 % (17/17; P = 0.23), 78.9 % (15/19) vs. 76.5 % (13/17; P > 0.99), and 26.3 % (5/19) vs. 35.3 % (6/17; P = 0.56), respectively. Within 3 and 6 months, RBO rates of group A vs. group B were 26.7 % (4/15) vs. 88.2 % (15/17; P  = 0.001) and 22.2 % (2/9) vs. 100 % (9/9; P = 0.002), respectively. At 3 months, median number of biliary reinterventions in group A was significantly lower than in group B (0 [interquartile range] 0-1 vs. 1 [1-2.5]), respectively (P < 0.001). Median time to development of RBO was longer in group A than in group B (92 [56-217] vs. 40 [13.5-57.8] days, respectively; P  =  0.06). CONCLUSIONS: Combined ERCP and EUS procedures provided significantly lower RBO rates at 3 and 6 months vs. bilateral PTBD, with similar complication rates and no significant mortality difference.

Endoscopic ultrasound guided fine needle biopsy (EUS-FNB) from peritoneal lesions: a prospective cohort pilot study.

BACKGROUND: Diagnostic laparoscopy is often a necessary, albeit invasive, procedure to help resolve undiagnosed peritoneal diseases. Previous retrospective studies reported that EUS-FNA is feasible on peritoneal and omental lesions, however, EUS-FNA provided a limited amount of tissue for immunohistochemistry stain (IHC). AIM: This pilot study aims to prospectively determine the effectiveness of EUS-FNB regarding adequacy of tissue for IHC staining, diagnostic rate and the avoidance rate of diagnostic laparoscopy or percutaneous biopsy in patients with these lesions. METHODS: From March 2017 to June 2018, patients with peritoneal or omental lesions identified by CT or MRI at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand were prospectively enrolled in the study. All Patients underwent EUS-FNB. For those with negative pathological results of EUS-FNB, percutaneous biopsy or diagnostic laparoscopy was planned. Analysis uses percentages only due to small sample sizes. RESULTS: A total of 30 EUS-FNB passes were completed, with a median of 3 passes (range 2-3 passes) per case. For EUS-FNB, the sensitivity, specificity, PPV, NPV and accuracy of EUS-FNB from peritoneal lesions were 63.6%, 100%, 100%, 20% and 66.7% respectively. Adequate tissue for IHC stain was found in 25/30 passes (80%). The tissues from EUS results were found malignant in 7/12 patients (58.3%). IHC could be done in 10/12 patients (83.3%). Among the five patients with negative EUS results, two underwent either liver biopsy of mass or abdominal paracentesis, showing gallbladder cancer and adenocarcinoma. Two patients refused laparoscopy due to advanced pancreatic cancer and worsening ovarian cancer. The fifth patient had post-surgical inflammation only with spontaneous resolution. The avoidance rate of laparoscopic diagnosis was 58.3%. No major adverse event was observed. CONCLUSIONS: EUS-FNB from peritoneal lesions provided sufficient core tissue for diagnosis and IHC. Diagnostic laparoscopy can often be avoided in patients with peritoneal lesions.

Low rate of recurrent bleeding after double-balloon endoscopy-guided therapy in patients with overt obscure gastrointestinal bleeding.

BACKGROUND: Double-balloon endoscopy (DBE) provides both diagnosis and treatment in overt obscure gastrointestinal bleeding (OGIB). The aim of this study was to evaluate the rebleeding rate after DBE. METHODS: This retrospective review was conducted between January 2006 and July 2018, 166 patients with overt OGIB who underwent DBE were enrolled. Therapeutic intervention was defined as endoscopic treatment, embolization, or surgery. Primary outcome was rebleeding rate after DBE. The patients were divided into 3 groups based on their DBE; (1) positive DBE requiring therapeutic intervention (G1), (2) positive DBE without therapeutic intervention required (G2) and (3) negative DBE (G3). Cumulative incidence of rebleeding was estimated using the Kaplan-Meier method. Cox regression was used to assess the association of DBE with rebleeding risk. This study was approved by our Institutional Review Board. RESULTS: Sixty-eight patients (41%) were categorized in G1, 34 patients (20%) in G2 and 64 patients (39%) in G3. Overall rebleeding occurred in 24 patients (15%). The cumulative incidence of rebleeding for G1 was the lowest. The 1-year and 2-year cumulative probability of developing rebleeding after DBE in G1 were 3.5% and 3.5%, 8.2% and 14.0% in G2, and 18.2% and 20.6% in G3, respectively (p = 0.02). After adjusting for bleeding severity and comorbidities, patients with positive DBE requiring therapeutic intervention had a significantly lower rate of rebleeding when compared with patients who did not receive intervention (hazard ratio 0.17; 95% CI 0.03-0.90). CONCLUSION: DBE-guided therapeutic intervention was associated with a lower risk of rebleeding when compared with those with negative and positive DBE without therapeutic intervention. One-fifth of patients with overt OGIB had false negative after DBE.

Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial.

BACKGROUND: Long-term placement of lumen apposing metal stents (LAMS) with high lumen apposing force may result in adverse events. The aim of the current study was to assess the long-term efficacy and safety of a self-approximating LAMS with lower lumen apposing force for endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and -gallbladder drainage (EUS-GBD). METHODS: Five Asian institutions participated in this study. Consecutive patients suffering from obstructive jaundice with failed ERCP or acute cholecystitis that were at high risk for cholecystectomy were recruited. We evaluated the technical and clinical success rates, adverse events rates, types of interventions through the stent and the patency profile. RESULTS: From June 2017 to Oct 2018, a total of 53 patients received EUS-CDS (26) and EUS-GBD (27). The technical and clinical success rates were similar between the two groups (88.5% vs 88.9%, P = 1 and 88.5% vs 88.9%, P = 1 respectively). The differences in 30-day mortality rates [2 (7.7%) vs 2 (7.7%), P = 1] and adverse events [3 (11.5%) vs 3 (11.5%), P = 1] did not reach significance. Regarding long-term outcomes, two patients in each group suffered from adverse events (P = 1). One patient in the EUS-GBD group who was on direct oral anticoagulant suffered from stent induced bleeding. CONCLUSION: The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term. The ClinicalTrials.gov Identifier was NCT03002051.

Single-operator peroral cholangioscopy cystic duct cannulation for transpapillary gallbladder stent placement in patients with acute cholecystitis at moderate to high surgical risk (with videos).

BACKGROUND AND AIMS: One of the main reasons for failed endoscopic transpapillary gallbladder stenting (ETGS) under fluoroscopic guidance is the inability to cannulate the cystic duct. Single-operator peroral cholangioscopy (SOC)-assisted ETGS is an adjunct technique to facilitate ETGS. We aimed to demonstrate its efficacy. METHODS: Between 2015 and 2019, 104 patients with acute cholecystitis at moderate to high surgical risk underwent ETGS, which involved 3 steps: (1) cystic duct cannulation under fluoroscopic guidance with or without additional SOC guidance; (2) guidewire placement; and (3) stent placement in the gallbladder. The technical success rate was determined when stent placement was confirmed endoscopically and radiographically. RESULTS: Of 104 patients, 55 (53%) patients had successful ETGS under fluoroscopic guidance. Of 49 patients who had failed fluoroscopy-guided ETGS, 41 patients underwent additional SOC-assisted ETGS and 5 patients proceeded to other interventions. Of patients who underwent SOC-assisted ETGS (n = 41), 23 (56%) cystic cannulation followed by stent placement were successful; cystic duct cannulations, guidewire, and stent placement failed in 8, 9, and 1 patients, respectively. The overall technical success rate of ETGS increased from 53% (55 of 104) to 75% (78 of 104) after additional SOC assistance. Adverse events and recurrence were not different between patients who underwent ETGS under fluoroscopic guidance and those who underwent SOC-assisted ETGS. CONCLUSIONS: In patients with acute cholecystitis who are not surgical candidates, SOC-assisted ETGS can increase the technical success rate after failed fluoroscopic guidance. SOC can help for the cystic duct cannulation and guidewire placement steps but not for the stent placement step.

EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video).

BACKGROUND AND AIMS: Previous studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of intraductal papillary mucinous neoplasms (IPMNs). We sought to derive EUS-guided nCLE criteria for differentiating IPMNs with high-grade dysplasia/adenocarcinoma (HGD-Ca) from those with low/intermediate-grade dysplasia (LGD). METHODS: We performed a post hoc analysis of consecutive IPMNs with a definitive diagnosis from a prospective study evaluating EUS-guided nCLE in the diagnosis of pancreatic cysts. Three internal endosonographers reviewed all nCLE videos for the patients and identified potential discriminatory EUS-guided nCLE variables to differentiate HGD-Ca from LGD IPMNs (phase 1). Next, an interobserver agreement (IOA) analysis of variables from phase 1 was performed among 6 blinded external nCLE experts (phase 2). Last, 7 blinded nCLE-naïve observers underwent training and quantified variables with the highest IOA from phase 2 using dedicated software (phase 3). RESULTS: Among 26 IPMNs (HGD-Ca in 16), the reference standard was surgical histopathology in 24 and cytology confirmation of metastatic liver lesions in 2 patients. EUS-guided nCLE characteristics of increased papillary epithelial "width" and "darkness" were the most sensitive variables (90%; 95% confidence interval [CI], 84%-94% and 91%; 95% CI, 85%-95%, respectively) and accurate (85%; 95% CI, 78%-90% and 84%; 95% CI, 77%-89%, respectively) with substantial (κ = 0.61; 95% CI, 0.51-0.71) and moderate (κ = 0.55; 95% CI, 0.45-0.65) IOAs for detecting HGD-Ca, respectively (phase 2). Logistic regression models were fit for the outcome of HGD-Ca as predictor variables (phase 3). For papillary width (cut-off ≥50 µm), the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.95, respectively. For papillary darkness (cut-off ≤90 pixel intensity), the sensitivity, specificity, and AUC for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.90, respectively. CONCLUSIONS: In this derivation study, quantification of papillary epithelial width and darkness identified HGD-Ca in IPMNs with high accuracy. These quantifiable variables can be used in multicenter studies for risk stratification of IPMNs. (Clinical trial registration number: NCT02516488.).

A newly designed duodenoscope with detachable distal cap significantly reduces organic residue contamination after reprocessing.

BACKGROUND: A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high-level disinfection (HLD). METHODS: During December 2018-April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n = 54), the distal cap of the duodenoscope was detached before manual cleaning. In group B (n = 54), the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs). RESULTS: After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 % vs. 75.9 %; P  < 0.001; relative risk 0.49, 95 % confidence interval 0.33-0.71), and also confirmed by median ATP values (45.2 vs. 141.0 RLU; P  < 0.001). In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group. CONCLUSIONS: The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.

Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy.

BACKGROUND: A novel self-approximating lumen-apposing metallic stent (LAMS; Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea) has recently become available. The aim of the present study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC). METHODS: This was a prospective international multicentered study conducted in six high-volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled-off pancreatic necrosis (WOPN) requiring endoscopic ultrasonography-guided drainage were recruited. Outcomes included technical and clinical success, adverse events, procedural events, interventions through the stent and recurrence rates. RESULTS: Between August 2016 and November 2017, 59 patients were recruited to this study. Thirty-nine patients (66.1%) had WOPN and mean (SD) size of PFC was 11.5 (5.1) cm. Technical and clinical success rates were 100%. Mean (SD) procedural time was 35.0 (17.2) minutes. Sixteen-millimeter stents were used in 66.1% of the patients. Fifty-four sessions of necrosectomy were carried out with the stent in situ in 17 patients. Stent-related adverse event (AE) rate was 6.8%. Three patients (5.1%) suffered from bleeding after stenting and one required angiographic embolization. Two patients (3.4%) suffered from recurrence during a mean (SD) follow-up time of 325.6 (355.5) days. There were no differences in outcomes between those with pseudocysts or WOPN except for the duration of hospital stay (P = 0.012). CONCLUSION: Use of a self-approximating LAMS for drainage of PFC was safe and effective. Endoscopic necrosectomy could be carried out through the stent with ease. The device was associated with a low rate of stent-related AE.

Digital cholangioscopy-guided laser versus mechanical lithotripsy for large bile duct stone removal after failed papillary large-balloon dilation: a randomized study.

BACKGROUND: Endoscopic papillary large-balloon dilation (EPLBD) allows for the complete removal of large common bile duct (CBD) stones without fragmentation; however, a significant proportion of very large stones and stones floating above a tapering CBD require lithotripsy. Mechanical lithotripsy and cholangioscopy-guided laser lithotripsy are both effective for stone fragmentation. This study aimed to directly compare, for the first time, the efficacy of these two techniques in terms of stone clearance rate, procedure duration, patient radiation exposure, and safety. METHODS: 32 patients with very large CBD stones or with stones floating above a tapering CBD, and in whom extraction after standard sphincterotomy and/or EPLBD had failed, were randomly assigned to mechanical lithotripsy or cholangioscopy-guided laser lithotripsy at two tertiary referral centers. Crossover was allowed as a rescue treatment if the assigned technique failed. RESULTS: Patients' demographic data were not different between the two groups. Mechanical lithotripsy had a significantly lower stone clearance rate in the first session compared with laser lithotripsy (63% vs. 100%; P < 0.01). Laser lithotripsy rescued 60% of patients with failed mechanical lithotripsy by achieving complete stone clearance within the same session. Radiation exposure of patients was significantly higher in the mechanical lithotripsy group than in the laser lithotripsy group (40 745 vs. 20 989 mGycm2; P  = 0.04). Adverse events (13% vs. 6%; P  = 0.76) and length of hospital stay (1 vs. 1 day; P  = 0.27) were not different. CONCLUSIONS: Although mechanical lithotripsy is the standard of care for a very large CBD stone after failed EPLBD, where available, cholangioscopy-guided laser lithotripsy is considered the better option for the treatment of this entity as it provides a higher success rate and lower radiation exposure.