EUS-guided radiofrequency ablation plus chemotherapy versus chemotherapy alone for pancreatic cancer (ERAP): An observational open-label pilot study.

Background: No study has compared EUS-guided radiofrequency ablation (EUS-RFA) plus systemic chemotherapy (CMT) with CMT alone for unresectable pancreatic ductal adenocarcinoma. Methods: This study compared the results of treatment in patients receiving EUS-RFA plus concomitant CMT (group A; n = 14) with those receiving CMT (group B; n = 14) as a pilot study. Results: From July 2017 to August 2018, 4 and 2 patients from groups A and B, respectively, withdrew from the study because of progression of the disease. In total, 10 and 12 patients from groups A and B, respectively, completed the study. All 30 EUS-RFA procedures were successful. Mean maximal tumor diameter before treatment of group A (n = 10) versus B (n = 12) was 62.2 ± 21.0 versus 50.5 ± 22.0 mm, respectively (P = not significant). After treatment, no statistically significant difference in mean maximal tumor diameter was found between both groups. However, in group B, mean maximal tumor diameter was significantly increased from 50.5 ± 22.0 to 56.3 ± 18.7 mm, respectively (P = 0.017). Tumor necrosis occurred in group A versus B at 10 of 10 (100%) versus 6 of 12 (50%) patients, respectively (P = 0.014). After treatment, group A patients could reduce the mean narcotic pain drug dosage at 26.5 mg of morphine equivalent per day (from 63.6 to 37.1 mg, P = 0.022), whereas group B patients could not reduce the dosage of pain-controlled medication. No statistically significant difference in 6-month mortality rate was found. In group A, 1 procedure-related nonsevere adverse event (n = 1 of 30 [3.3%]) occurred in 1 patient (n = 1 of 14 [7.1%]). Conclusions: In this study, the mean tumor diameter of group B was significantly increased after the treatment. Group A had a significantly higher rate of necrosis of tumor and required less narcotic.

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.).

Drainage of Complex Walled-Off Pancreatic Fluid Collections in LAMS Era: A Multicenter Study.

Background: The lumen-apposing metal stent (LAMS) has been increasingly used for EUS-guided drainage of symptomatic walled-off pancreatic fluid collection (WOPFC) in recent years. Nevertheless, some WOPFCs may require additional drainage methods including another LAMS as a result of complexity of the lesions. This current study aimed to compare clinical parameters of patients with complex WOPFC requiring LAMS with additional methods (complex WOPFC: group A) versus single LAMS alone (noncomplex WOPFC; group B). Method: Medical records of patients with complex (group A) versus noncomplex WOPFCs (group B) were reviewed and compared in three centers in Thailand and Malaysia, between January 2016 to December 2020. Result: 31 patients with WOPFCs were recruited. 6 of 31 (19%) patients were in group A. Multivariate analysis showed that the maximal diameter of WOPFCs in group A was significantly larger than that of group B (18 ± 6 versus 13 ± 3 cm in diameter, respectively, p = 0.021). Solid component proportion was higher in group A versus B (35.8% versus 17.8%, respectively, p = 0.025). The prevalence of pancreatic duct leakage was significantly higher in group A (67% versus 20%, p = 0.23). The need of direct endoscopic necrosectomy (DEN) and the number of DEN sessions were higher in group A versus B (100% vs. 48%, p = 0.020 and 3.5 vs 0 p = 0.031, respectively). Conclusions: Complex WOPFC had larger diameter of lesions, higher proportion of solid component, higher prevalence of pancreatic duct leakage, and higher number of DEN is required than group noncomplex lesions. Trial Registration. This trial is registered with TCTR20180223004.

Ultimate outcomes of three modalities for non-surgical gallbladder drainage in acute cholecystitis with or without concomitant common bile duct stones.

BACKGROUNDS/AIMS: In moderate and high-surgical risk patients with acute cholecystitis, studies comparing percutaneous cholecystostomy (PC) vs. endoscopic transpapillary gallbladder stenting (ETGS) vs. endoscopic ultrasound-guided transmural gallbladder stenting (EUGS) are limited. Thus, the aim of this study was to compare efficacy and recurrence of cholecystitis after PC, ETGS, or EUGS during follow-up. METHODS: We reviewed 143 moderate and high-surgical risk patients with acute cholecystitis with or without concomitant common bile duct stones who underwent PC, ETGS, or EUGS at our hospital. Technical success rate (TSR), clinical success rate (CSR), and recurrence were compared. RESULTS: TSR in PC or EUGS group was higher than that in the ETGS group for those with concomitant common bile duct stones (100% vs. 100% vs. 73.2%; p = 0.07) and for those without concomitant common bile duct stones (100% vs. 100% vs. 77.3%; p < 0.001). CSR in ETGS or EUGS group was higher than that in the PC group for those with concomitant common bile duct stones (96.2% vs. 100% vs. 87.5%; p = 0.41) and for those without concomitant common bile duct stones (94.1% vs. 100% vs. 63.0%; p = 0.006). Using Kaplan-Meier analysis, the overall recurrent risk was the highest in the PC group (p = 0.004). CONCLUSIONS: In moderate and high-surgical risk patients with acute cholecystitis, EUGS provides significantly higher CSR with comparable TSR to PC. Thus, ETGS should be the first choice in those with concomitant common bile duct stones. Among the three patient groups, those who received PC had the highest rate of recurrence.

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.

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.

Bimodal Chromoendoscopy with Confocal Laser Endomicroscopy for the Detection of Early Esophageal Squamous Cell Neoplasms.

BACKGROUND/AIMS: This study aimed to evaluate the diagnostic accuracy of dual-focus narrow-band imaging (dNBI) and Lugol'schromoendoscopy (LCE) combined with probe-based confocal laser endomicroscopy (pCLE) to screen for esophageal squamous cell neoplasms (ESCNs) in patients with a history of head and neck cancer. METHODS: From March to August 2016, dNBI was performed. Next, LCE was performed, followed by pCLE and biopsy. Histology has historically been the gold standard to diagnose ESCN. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of dNBI and LCE adjunct with pCLE were determined. RESULTS: Twenty-four patients were included. Ten ESCNs were found in 8 patients (33%). Forty percent of high-graded intraepithelial neoplasias and all low-grade intraepithelial neoplasias were overlooked by dNBI. The sensitivity, specificity, PPV, NPV, and accuracy of dNBI vs. LCE combined with pCLE were 50% vs. 80%, 62% vs. 67%, 36% vs. 44%, 75% vs. 91%, and 83% vs. 70%, respectively. CONCLUSION: The use of dNBI to detect ESCN was suboptimal. LCE with pCLE following dNBI had additional value for detecting esophageal dysplasia not detected by dNBI. The use of pCLE to detect dNBI-missed lesions yielded a high NPV, while pCLE-guided biopsy could reduce the number of unnecessary biopsies.

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.