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).

Improvement of adenoma detection rate by two computer-aided colonic polyp detection systems in high adenoma detectors: a randomized multicenter trial.

BACKGROUND: This study aimed to evaluate the benefits of a self-developed computer-aided polyp detection system (SD-CADe) and a commercial system (CM-CADe) for high adenoma detectors compared with white-light endoscopy (WLE) as a control. METHODS: Average-risk 50-75-year-old individuals who underwent screening colonoscopy at five referral centers were randomized to SD-CADe, CM-CADe, or WLE groups (1:1:1 ratio). Trainees and staff with an adenoma detection rate (ADR) of ≥35% were recruited. The primary outcome was ADR. Secondary outcomes were the proximal adenoma detection rate (pADR), advanced adenoma detection rate (AADR), and the number of adenomas, proximal adenomas, and advanced adenomas per colonoscopy (APC, pAPC, and AAPC, respectively). RESULTS: The study enrolled 1200 participants. The ADR in the control, CM-CADe, and SD-CADe groups was 38.3%, 50.0%, and 54.8%, respectively. The pADR was 23.0%, 32.3%, and 38.8%, respectively. AADR was 6.0%, 10.3%, and 9.5%, respectively. After adjustment, the ADR and pADR in both intervention groups were significantly higher than in controls (all P<0.05). The APC in the control, CM-CADe, and SD-CADe groups was 0.66, 1.04, and 1.16, respectively. The pAPC was 0.33, 0.53, and 0.64, respectively, and the AAPC was 0.07, 0.12, and 0.10, respectively. Both CADe systems showed significantly higher APC and pAPC than WLE. AADR and AAPC were improved in both CADe groups versus control, although the differences were not statistically significant. CONCLUSION: Even in high adenoma detectors, CADe significantly improved ADR and APC. The AADR tended to be higher with both systems, and this may enhance colorectal cancer prevention.

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.

Computer-aided detection, mucosal exposure device, their combination, and standard colonoscopy for adenoma detection: a randomized controlled trial.

BACKGROUND AND AIMS: Computer-aided detection (CADe) and a mucosal exposure device can improve adenoma detection rate (ADR). Potential benefits of combining the 2 modalities have never been studied. This study aimed to compare ADR differences among CADe alone, endocuff-assisted colonoscopy (EAC) alone, and the combination of CADe and EAC (CADe+EAC) with standard colonoscopy. METHODS: This prospective randomized controlled study included 1245 participants who underwent screening colonoscopy. Participants were randomized to CADe, EAC, CADe+EAC, and standard colonoscopy as a control. The primary outcome was ADR. Secondary outcomes were proximal ADR (pADR), advanced ADR (AADR), and the number of adenomas per colonoscopy (APCs). RESULTS: ADRs from the control, CADe, EAC, and CADe+EAC groups were 41.9%, 52.2%, 54.0%, and 58.8%, respectively; pADRs were 25.2%, 33.3%, 34.9%, and 37.0%, respectively; AADRs were 7.7%, 8.3%, 8.3%, and 13.6%, respectively; and APCs were .76, 1.11, 1.18, and 1.31, respectively. Significant increases in ADR and pADR were observed between the intervention and control groups (P < .05 in all comparisons). The AADR was significantly higher only in the CADe+EAC group than in the control group (P = .02). The adjusted incidence rate ratios of APCs were significantly higher in the intervention groups versus the control group (P < .01 in all comparisons). CONCLUSIONS: CADe+EAC significantly improve ADR and AADR over standard colonoscopy. However, although CADe or EAC alone can substantially increase the detection of adenomas, they do not lead to increased detection of advanced adenomas unless used in combination. (Clinical trial registration number: TCTR20200929003.).

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.

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.

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.

Linked color imaging, mucosal exposure device, their combination, and standard colonoscopy for adenoma detection: a randomized trial.

BACKGROUND AND AIMS: By different mechanisms, image-enhancement techniques (linked color imaging [LCI]) and mucosal exposure devices (Endocuff-assisted colonoscopy [EAC]) can improve the adenoma detection rate (ADR) during screening colonoscopy. The impact of the combination of the 2 techniques has never been studied. This study aimed to compare the ADR between the combination of LCI and EAC (LCI+EAC), LCI alone, EAC alone, and standard high-definition (HD) colonoscopy. METHODS: This prospective randomized controlled trial included participants who underwent screening colonoscopy. Participants were randomized to LCI+EAC, LCI, EAC, and standard HD colonoscopy. All colonoscopies were performed by endoscopists with a recorded ADR ≥35%. The primary outcome was the ADR. Secondary outcomes were proximal ADR (pADR) and the mean number of adenomas per colonoscopy (APC). RESULTS: One thousand participants were included in the study. The LCI+EAC group provided the highest ADR and pADR. The ADRs in the LCI+EAC, LCI, EAC, and standard HD colonoscopy groups were 57.2%, 52.8%, 51.6%, and 47.6%, respectively, with pADRs of 38.4%, 34.8%, 33.6%, and 28.0%, respectively. The mean numbers of APC were 1.28, 1.20, 1.16, and .89, respectively. After a multiple comparison adjustment, a significant difference in pADR was only observed between the LCI+EAC and standard HD colonoscopy groups (difference, 10.3 percentage points; 95% confidence interval, .02%-17.4%; P = .05). The incidence rate ratios of the adenoma numbers were significantly higher in the LCI+EAC (1.43), LCI (1.34), and EAC (1.30) groups relative to the standard HD colonoscopy group (.89) (P < .009 for all comparisons). CONCLUSIONS: The combination of LCI and EAC can significantly improve the detection of pADR and APC but not ADR by high-ADR performers. (Clinical trial registration number: TCTR20190319001.).

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.

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.

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.

Predictors of advanced fibrosis in elderly patients with biopsy-confirmed nonalcoholic fatty liver disease: the GOASIA study.

BACKGROUND: The Gut and Obesity in Asia (GOASIA) Workgroup was formed to study obesity and gastrointestinal diseases in the Asia Pacific region. We aimed to 1) compare the characteristics of elderly (i.e. age ≥ 60) vs. non-elderly patients with biopsy-proven nonalcoholic fatty liver disease (NAFLD); 2) identify predictors of advanced fibrosis in elderly patients with NAFLD; and 3) assess the performance of non-invasive fibrosis scores in the prediction of advance fibrosis in the elderly population. METHODS: We abstracted the data of 1008 patients with NAFLD from nine centers across eight countries. Characteristics of elderly and non-elderly patients with NAFLD were compared using 1:3 sex-matched analysis. RESULTS: Of the 1008 patients, 175 were elderly [age 64 (62-67) years], who were matched with 525 non-elderly patients [46 (36-54) years]. Elderly patients were more likely to have advanced fibrosis (35.4% vs. 13.3%; p < 0.001). By multivariable analysis, factors associated with advanced fibrosis in elderly patients included female sex [odds ratio (OR) 3.21; 95% confidence interval (CI) 1.37-7.54] and hypertension (OR 3.68; 95%CI 1.11-12.23). The area under receiver-operating characteristics curve (95% CI) of aspartate aminotransferase-to-platelet ratio index, NAFLD fibrosis score and Fibrosis-4 index for predicting advanced fibrosis in elderly patients were 0.62 (0.52-0.72), 0.65 (0.55-0.75) and 0.64 (0.54-0.74) respectively. CONCLUSIONS: Elderly patients with NAFLD had a higher prevalence of advanced fibrosis than non-elderly patients. Female and hypertension were predicting factors for advanced fibrosis in the elderly. Non-invasive fibrosis scores had a lower specificity in elderly.

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.

Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial.

BACKGROUND AND AIM: Long-term use of dual antiplatelets is increasing, and most patients need primary peptic ulcer prophylaxis. The long-term use of proton pump inhibitors (PPIs) is associated with adverse events. We evaluated the efficacy of rebamipide for peptic ulcer prevention. METHODS: This randomized controlled trial was conducted between July 2014 and November 2017. Patients receiving dual antiplatelets for ≥ 1 year with no history of peptic ulcer bleeding or perforation were recruited and randomly assigned to the rebamipide (300 mg/day) group or the placebo group. Patients who used proton pump inhibitors were excluded. The primary endpoint was a new mucosal break on esophagogastroduodenoscopy at 3 or 12 months after treatment initiation. The secondary endpoints were hematocrit changes from the baseline, gastrointestinal bleeding, and chest pain. Antiplatelet function was assessed. RESULTS: In total, 95 eligible patients were identified; 12 were excluded, and 83 patients were randomized, with 66 (79.5%) and 59 (71.1%) patients eligible at the 3- and 12-month follow ups, respectively. The baseline characteristics were equivalent between the groups. During the 12 months of follow up, 13 patients (43.3%) taking rebamipide and 19 (65.5%) taking the placebo experienced mucosal injury (P = 0.07). Two patients (6.7%) taking rebamipide and eight (27.6%) taking the placebo had peptic ulcers ≥ 5 mm or < 5 mm with pigmented spots (P = 0.03). The changes in hematocrit were not different between the two groups. Neither bleeding ulcers nor chest pain was observed. CONCLUSION: Rebamipide is safe and may prevent peptic ulcers ≥ 5 mm in diameter or those with pigmented spots in patients receiving dual antiplatelets for 1 year (NCT02166008).

The impact of empiric endoscopic biliary sphincterotomy on future gallstone-related complications in patients with non-severe acute biliary pancreatitis whose cholecystectomy was deferred or not performed.

BACKGROUND: Early cholecystectomy (EC) is recommended in patients with acute biliary pancreatitis (ABP). In real-life practice, cholecystectomy is frequently deferred due to various reasons and delayed cholecystectomy (DC) is performed instead. Endoscopic sphincterotomy (ES) is an alternative to prevent recurrent pancreatitis, however other gallstone-related complications (GCs) may still develop. We aimed to determine the impact of ES on future GCs in patients with non-severe acute biliary pancreatitis whose cholecystectomy was deferred or not performed. METHODS: During 2006-2016, we included patients with non-severe ABP while those with severe pancreatitis and concurrent cholangitis were excluded. GC events were compared between those who had DC with ES and those who had DC without ES. A similar comparison was made in patients with and without ES who did not receive cholecystectomy. RESULTS: Of 266 patients with ABP, non-severe ABP was identified in 146. Only 16 (11%) had EC. Of patients with non-severe ABP who underwent DC (n = 88), recurrent ABP in the ES group was lower than those from the non-ES group (2% vs. 17%; p = 0.01). Acute cholecystitis was found in 0%, 6% and 10% of patients with EC, DC and those without cholecystectomy (p = 0.39). Of those who did not undergo cholecystectomy (n = 42), recurrent ABP in the ES group was still lower than the non-ES group (4% vs. 36%; p = 0.006). ES related complications were mild pancreatitis (4%) and post sphincterotomy bleeding (5%). CONCLUSIONS: In patient with non-severe ABP, ES is an alternative to reduce recurrent ABP, however without EC, future cholecystitis may still develop.

Uncomplicated common bile duct stone removal guided by cholangioscopy versus conventional endoscopic retrograde cholangiopancreatography.

BACKGROUND: Although previous studies have reported the possibility of therapeutic ERCP without fluoroscopy, more robust documentation of fluoroscopy-free common bile duct stone (CBDS) clearance is needed. Technically, "digital cholangioscopy" (DCS) may be used to confirm CBDS clearance. We aimed to compare the feasibility, safety, and radiation exposure between patients with CBDS undergoing stone removal by DCS and conventional ERCP (cERCP). METHODS: Fifty (50) consecutive patients with a CBDS size < 15 mm underwent DCS (SpyGlass DS Direct Visualization System, Boston Scientific, Marlboro, MA, USA) between December 2015 and October 2016. Of 202 consecutive patients undergoing cERCP during the same time frame, 50 matched pairs were created using propensity score matching analysis. In the DCS group, patients underwent biliary cannulation and CBDS removal without fluoroscopy followed by DCS to confirm complete CBDS clearance. A final occlusion cholangiogram was performed as the current standard of care to confirm CBDS clearance. RESULTS: Cannulation success rates were similar between the DCS and cERCP groups (98 vs. 98%). By intention-to-treat analysis, CBDS clearance in the DCS and cERCP groups was not different (90 vs. 98%; p = 0.20, respectively). DCS had successful CBDS removal in 45 cases, whereas 5 (10%) failed for clearance by DCS due to technical limitations. Adverse events were not different between both groups. CONCLUSIONS: In the management of uncomplicated CBDS, our data confirmed the feasibility of DCS for CBDS clearance as it showed efficacy and safety comparable to those of cERCP. Although certain conditions may limit its effectiveness, DCS offers the ability to perform CBDS clearance without the need for fluoroscopy unit and can avoid radiation exposure while ERCP under fluoroscopy remains the current standard of care in patients with CBDS.