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).

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.

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.

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.

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.).

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.

Successful hemostasis by percutaneous transhepatic cyanoacrylate injection for hepatic artery pseudoaneurysm causing hemobilia.

A 73-year-old man, post-liver transplantation, was scheduled for ERCP to evaluate anastomotic biliary stricture. The patient developed massive bleeding from hepatic artery pseudoaneurysm. Angiography via femoral artery could not identified feeding artery of the pseudoaneurysm. Thus, trans-abdominal ultrasonography was performed and percutaneous transhepatic glue embolization successfully.

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.

Diagnostic performance of digital and video cholangioscopes in patients with suspected malignant biliary strictures: a systematic review and meta-analysis.

BACKGROUND: Per-oral cholangioscopy (POC) has evolved over the past decade from fiberoptic to digital and video imaging systems. Nowadays, only direct per-oral cholangioscopy (DPOC) and digital single-operator cholangioscopy (DS) are performed in daily practice. With better image resolution, POC is increasingly used as diagnostic tools in patients with suspected malignant biliary stricture (MBS). We aimed to evaluate the diagnostic yield of digital/video cholangioscopes for the diagnosis of MBS. METHODS: A systematic search was performed in MEDLINE, Embase, and ISI Web of Knowledge databases until April 2020, to identify randomized controlled trials and prospective studies using digital or video POC. The meta-analysis of diagnostic accuracy study was performed to calculate summary estimates of the primary outcomes, including pooled sensitivity, and specificity of POC to diagnose MBS using bivariate random-effects models. Tissue histopathology was used as the reference standard for MBS diagnosis. For benign stricture, negative tissue histopathology and at least 6 months clinical follow-up were required. RESULTS: Thirteen original articles with 876 patients were identified. The overall pooled sensitivity and specificity were 88 (95% CI 83-91) and 95 (95% CI 89-98), respectively. The area under the curve (AUROC) was 0.94 (95% CI 0.92-0.96). Subgroup analysis showed that cholangioscopic image impression provided significantly higher sensitivity (93% (95% CI 88-96) vs 82% (95% CI 76-87); p = 0.007), but lower specificity 86% (95% CI 75-92) vs 98 (95% CI 95-99); p < 0.001) than the tissue diagnosis from cholangioscopic-guided biopsy. In addition, biopsy obtained from DPOC had significantly higher sensitivity than that of DS (92% (95% CI 81-97) vs 79% (95% CI 72-84); p = 0.004). Diagnostic performance under image-enhanced endoscopy was not significantly better from white light endoscopy. CONCLUSIONS: Digital/video POC has very high diagnostic performance to diagnose MBS. While image diagnosis provides higher sensitivity than biopsy, its specificity drops as a trade-off.

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.).

Sleep Quality of Hospitalized Patients, Contributing Factors, and Prevalence of Associated Disorders.

BACKGROUND: Data in the literature has shown poor sleep quality to be frequently observed in hospitalized patients and known to be associated with poor treatment outcome. Many factors may impact poor sleep quality, and there is currently limited available data. We aim to determine the prevalence of poor sleep quality and associated factors in patients admitted to internal medicine wards as well as the change of sleep quality over time after admission. METHODS: An analytic observational study was conducted at the internal medicine wards at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Patients were personally interviewed to evaluate the history of sleep quality at home, sleep quality after the first and the third days of admission, and potential associated factors. The Pittsburgh Sleep Quality Index and screening questionnaires for the common diseases associated with poor sleep quality were also utilized. The logistic regression analysis was used to determine the independent factors which led to poor sleep quality. RESULTS: Data were collected from 96 patients during the period of June 2015 to February 2016. The mean age of the patients was 50.8 ± 16.7 years, and 51% were male. Infectious disease was the most common principal diagnosis accounted for 29.2%. The results show high prevalence of poor sleep quality after the first night of admission compared to baseline sleep quality at home (50% vs. 18.8%; p < 0.001). After 3 days of admission, the prevalence of poor sleep quality was reduced to the level close to baseline sleep quality at home (28.1% vs. 18.8%; p = 0.13). Multivariate analysis demonstrated that light exposure and pain were the main independent factors for poor sleep quality on the first day (odds ratio 6.68; 95% CI 2.25-19.84) and on the third day (odds ratio 3.47; 95% CI 1.24-9.71), respectively. CONCLUSIONS: This is the first study conducted on the sleep quality of hospitalized patients that included the follow-up period during hospital admission. Our study demonstrated high prevalence of poor sleep quality in hospitalized patients on the first day. Interestingly, the sleep quality was partly improved during hospitalization. Light exposure and pain were demonstrated to be the factors associated with poor sleep quality.

Diagnostic performance of different cholangioscopes in patients with biliary strictures: a systematic review.

BACKGROUND: Cholangioscopy provides direct intraductual imaging, which can enhance diagnostic efficacy during endoscopic retrograde cholangiopancreatography in patients with biliary strictures. This study aimed to review the diagnostic yield of different cholangioscopes for the diagnosis of malignant biliary stricture (MBS). METHODS: A comprehensive literature review was performed. Full papers of prospective studies using any type of peroral cholangioscope (POC) were included without language restriction. The primary outcomes were sensitivity, specificity, and accuracy of various POCs to diagnose MBS. RESULTS: Data from 20 published articles, involving 1141 patients, were extracted. Overall sensitivities of POCs for diagnosing MBS were higher for the diagnosis made under visual impression compared with those from cholangioscopy-guided biopsy (67 % - 100 % vs. 38 % - 100 %), whereas the overall specificities were generally high and comparable (73 % - 100 % vs. 75 % - 100 %). Newer video cholangioscopes (digital single-operator POC [digital SOC], direct POC) with the exception of video dual-operator mother - baby POC (video DOC), provided better sensitivity of cholangioscopy-guided biopsy compared with fiberoptic scopes (digital SOC 80 % - 85 %, direct POC 80 % - 100 %, video DOC 38 % - 100 %, and fiberoptic SOC 49 % - 100 %, respectively). Among these video cholangioscopes, the digital SOC provided the highest technical success rate, at 100 %. CONCLUSIONS: POCs enhanced the diagnostic yield for diagnosis of MBS. Compared with fiberoptic POCs that only provide good image impression, the digital SOC and direct POC were good at both image impression and cholangioscopy-guided biopsy to diagnose MBS. To ensure high technical success for MBS diagnosis, the digital SOC is a good option.

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.

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.