Impact of fellow participation on colon adenoma detection rates: a multicenter randomized trial.

BACKGROUND AND AIMS: There are limited and conflicting data on the impact of fellow participation in improving the colon adenoma detection rate. We performed a multicenter randomized controlled trial to evaluate whether fellow involvement might have a beneficial effect on adenoma detection rate. METHODS: The trial was conducted at 4 tertiary hospitals between April and December 2019. Eight hundred twelve patients were randomized to undergo colonoscopy performed by a fellow under the supervision of a staff endoscopist or by an attending physician alone. RESULTS: No significant differences in demographic or adenoma risk factors were detected between the 2 groups. The adenoma detection rate in the intervention group was 44.8% versus 37.1% in the control arm (P = .02). The mean number of adenomas per colonoscopy was significantly higher in the intervention group (0.65 ± 0.3 vs 0.53 ± 0.2 in the control arm, P < .001). The polyp detection rate was 69.7% in the intervention group and 62.5% in the control arm (P = .03), whereas rates of advanced and sessile/serrated adenoma detection were not different between the trial arms (P = .50 and .42, respectively). In the subgroup of more experienced fellows, the adenoma detection rate and polyp detection rate were 49.5% and 75.7%, respectively. No difference was observed between less-experienced fellows and attending physicians alone (P = .53 and 0.86, respectively). The level of bowel preparation and fellow involvement were significant predictors of increased adenoma detection rate in a multivariate analysis. CONCLUSIONS: Our multicenter trial represents the first prospective validation of the beneficial role of fellow involvement in colonoscopy procedures. (Clinical trial registration number: NCT03908229.).

Echoendoscopic ethanol ablation of tumor combined with celiac plexus neurolysis in patients with pancreatic adenocarcinoma.

BACKGROUND AND AIM: Endoscopic ultrasonography guided-celiac plexus neurolysis relieves pain in patients with pancreatic cancer but with often suboptimal and transient results. The study aims to compare the efficacy and safety of endoscopic ultrasound-guided tumor ethanol ablation combined with celiac plexus neurolysis with respect to celiac plexus neurolysis alone for pain management in patients with pancreatic cancer. METHODS: Among 123 patients with unresectable pancreatic cancer referred to our Institution between 2006 and 2014, 58 treated with endoscopic ultrasound-guided celiac plexus neurolysis (Group 1) and 65 with the combined approach (Group 2) were compared. Logistic regression models were applied to identify predictors of pain relief. RESULTS: The two groups presented similar baseline clinical and tumoral parameters. Pre-procedural visual analog scale score was 7 in both groups (P = 0.8), and tumor max diameter was 38 mm (range 25-59) in Group 1 and 43 mm (22-59) in Group 2 (P = 0.4). The combined treatment increased pain relief and complete pain response rate (P = 0.005 and 0.003, respectively). Median duration of pain relief was 10 (7-14) and 18 (13-20) weeks in the two groups, respectively (P = 0.004). At multivariate regression, initial visual analog scale score and endoscopic technique adopted resulted significantly associated with pain relief. No severe treatment-related adverse events were reported. Median overall survival was 6.5 months (5.1-8.6) in Group 1 and 8.3 months (6-11.4) in Group 2 (P = 0.05). CONCLUSIONS: Endoscopic ultrasound-guided tumor ablation combined with celiac plexus neurolysis appears to be superior to celiac plexus neurolysis alone in terms of pain control and overall survival.

Factors Associated With Recurrence of Advanced Colorectal Adenoma After Endoscopic Resection.

BACKGROUND & AIMS: Studies have identified risk factors for recurrence of advanced colorectal adenoma (ACA) after polypectomy, but the relative importance and interaction of these risk factors, and their potential impact on surveillance recommendations, are unclear. We aimed to develop a model to identify ACA features associated with risk of recurrence after polypectomy. METHODS: In a retrospective study, we collected data from 3360 patients who underwent colonoscopy with polypectomy at University of Foggia from 2004 through 2008 and identified 746 patients with 1017 ACAs. We performed recursive partitioning analysis to identify factors associated with recurrence of ACA within 3 years after polypectomy. RESULTS: Median ACA size was 16 mm (range, 8-34 mm) and median number was 1.5 (range, 1-2). Pedunculated, sessile, and nonpolypoid lesions accounted for 41.3%, 39.4%, and 19.3% of ACAs detected, respectively. Factors independently associated with local recurrence of ACA and metachronous distant polyps within 3 years after polypectomy included size and number of ACAs and grade of dysplasia. The recurrence rate was 4.2% in patients with a single ACA ≤15 mm without high-grade dysplasia (HGD), 21.3% in patients with HGD ≤15 mm, ACA without HGD >15 mm, or multiple ACAs without HGD ≤15 mm, and 57.9% in patients with HGD >15 mm. CONCLUSIONS: In this retrospective analysis of 746 patients with ACA who underwent polypectomy and surveillance colonoscopy within 3 years, the recurrence rate was highest in those with HGD ≥15 mm. These patients might benefit from more intensive surveillance, whereas patients with a single ACA without HGD ≤15 mm are at lower risk for and could be considered for longer follow-up intervals.

Microwave ablation versus radiofrequency ablation for the treatment of hepatocellular carcinoma: A systematic review and meta-analysis.

PURPOSE: Radiofrequency ablation (RFA) and microwave ablation (MWA) are the two main percutaneous techniques for the treatment of unresectable hepatocellular carcinoma (HCC). However, to date, studies comparing the two therapies have provided discordant results. The aim of this meta-analysis is to evaluate the efficacy and safety of the two treatments for HCC patients. MATERIALS AND METHODS: A computerised bibliographic search was performed on PubMed/MEDLINE, Embase, Google Scholar and Cochrane library databases. The rates of complete response (CR), local recurrence (LRR), 3-year survival (SR) and major complications were compared between the two treatment groups by using the Mantel-Haenszel test in cases of low heterogeneity or the DerSimonian and Laird test in cases of high heterogeneity. Sources of heterogeneity were investigated using subgroup analyses. In order to confirm our finding, sensitivity analysis was performed restricting the analysis to high-quality studies. RESULTS: One randomised controlled trial (RCT) and six retrospective studies with 774 patients were included in the meta-analysis. A non-significant trend of higher CR rates in the patients treated with MWA was found (odds ratio (OR) = 1.12, 95% confidence interval (CI) 0.67-1.88, p = 0.67]. Overall LRR was similar between the two treatment groups (OR 1.01, 95% CI 0.53-1.87, p = 0.98) but MWA outperformed RFA in cases of larger nodules (OR 0.46, 95% CI 0.24-0.89, p = 0.02). 3-year SR was higher after RFA without statistically significant difference (OR 0.95, 95% CI 0.58-1.57, p = 0.85). Major complications were more frequent, although not significantly, in MWA patients (OR 1.63, 95% CI 0.88-3.03, p = 0.12). CONCLUSIONS: Our results indicate a similar efficacy between the two percutaneous techniques with an apparent superiority of MWA in larger neoplasms.

Polidocanol injection decreases the bleeding rate after colon polypectomy: a propensity score analysis.

BACKGROUND: EMR is the standard of care for the resection of large polyps. OBJECTIVE: To compare the efficacy and safety profile of submucosal polidocanol injection with epinephrine-saline solution injection for colon polypectomy with a diathermic snare. DESIGN: After 1-to-1 propensity score caliper matching, comparison of submucosal epinephrine injection was performed with polidocanol injection. SETTING: Endoscopic suite at the University of Foggia between 2005 and 2014. PATIENTS: Of 711 patients who underwent endoscopic resection of colon sessile polyps 20 mm or larger, 612 were analyzed after matching. INTERVENTIONS: Submucosal epinephrine injection in 306 patients and polidocanol injection in 306 patients. MAIN OUTCOME MEASUREMENTS: Univariate and multivariate logistic regression models aimed at identifying independent predictors of postpolypectomy bleeding (PPB). RESULTS: The 2 groups presented similar baseline clinical parameters and lesion characteristics. All patients had a single polyp 20 mm or larger; the median size was 32 mm (interquartile range [IQR], 25-38) in the polidocanol group and 32 (IQR, 24-38) in the epinephrine group (P=.7). Polidocanol was more effective in preventing both immediate and delayed PPB (P<.001 and P=.003, respectively), and its efficacy was confirmed in almost all of the subgroups, regardless of polyp size and histology. Postprocedure perforation was observed in 2 patients (0.3%), both in the epinephrine group (P=.49). The 2 groups did not differ in the number of snare resections of lesions or the procedure duration (P=.24 and .6, respectively). LIMITATIONS: Absence of randomization. CONCLUSION: The submucosal injection of polidocanol for colon EMR is effective and significantly lowers the PPB rate.

Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: A meta-analysis.

BACKGROUND: Robust data in favour of a clear superiority of 22 versus 25 Gauge needles for endoscopic ultrasound-guided fine needle aspiration are still lacking. OBJECTIVE: We aimed to compare the diagnostic sensitivity, specificity and safety of these two needles for endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions. METHODS: A computerized bibliographic search was restricted to randomized controlled trials only. Pooled effects were calculated using a random-effects model and expressed in terms of risk ratio and 95% confidence interval. RESULTS: We analysed seven trials with 689 patients and 732 lesions (295 sampled with 22 Gauge needle, 309 with 25 Gauge needle, and 128 with both needles). A non-significant superiority of 25 Gauge in terms of pooled sensitivity (risk ratio: 0.93, 0.91-0.95 versus 0.89, 0.85-0.94 of 22 Gauge needle; p = 0.13) and no difference in terms of specificity (1.00, 0.98-1.00 in both groups; p = 0.85) were observed. Sample adequacy was similar between the two devices (risk ratio: 1.03, 0.99-1.06; p = 0.15). Very few adverse events were observed and did not impact on patient outcomes. CONCLUSION: Our meta-analysis reveals non-superiority of 25 Gauge over 22 Gauge; hence no definitive recommendations over the use of one particular device can be made.

Drug-eluting beads versus conventional chemoembolization for the treatment of unresectable hepatocellular carcinoma: A meta-analysis.

BACKGROUND: Despite the promising results of earlier studies, a clear superiority of drug-eluting beads transarterial chemoembolization over conventional chemoembolization in unresectable hepatocellular carcinoma patients has not been established yet. AIMS: To evaluate the efficacy and safety of the two treatments in unresectable hepatocellular carcinoma patients. METHODS: Computerized bibliographic search on the main databases was performed. One-year, two-year, three-year survival rates were analyzed. Hazard ratios from Kaplan-Meier curves were extracted in order to perform an unbiased comparison of survival estimates. Objective response and severe adverse event rate were analyzed too. RESULTS: Four randomized-controlled trials and 8 observational studies with 1449 patients were included in the meta-analysis. Non-significant trends in favor of drug-eluting beads chemoembolization were observed as for 1-year (odds ratio: 0.76, 0.48-1.21, p=0.25), 2-year (odds ratio: 0.68, 0.42-1.12, p=0.13) and 3-year survival (odds ratio: 0.57, 0.32-1.01, p=0.06). Meta-analysis of plotted hazard ratios confirmed this trend (hazard ratio: 0.86, 0.71-1.03, p=0.10). Pooled data of objective response showed no significant difference between the two treatments (odds ratio: 1.21, 0.69-2.12, p=0.51). No statistically significant difference in adverse events was registered (odds ratio: 0.85, 0.60-1.20, p=0.36). CONCLUSIONS: Our results stand for a non-superiority of drug-eluting beads chemoembolization with respect to conventional chemoembolization in hepatocarcinoma patients.

Development and validation of a risk score for advanced colorectal adenoma recurrence after endoscopic resection.

AIM: To develop and validate a risk score for advanced colorectal adenoma (ACA) recurrence after endoscopic polypectomy. METHODS: Out of 3360 patients who underwent colon polypectomy at University of Foggia between 2004 and 2008, data of 843 patients with 1155 ACAs was retrospectively reviewed. Surveillance intervals were scheduled by guidelines at 3 years and primary endpoint was considered 3-year ACA recurrence. Baseline clinical parameters and the main features of ACAs were entered into a Cox regression analysis and variables with P < 0.05 in the univariate analysis were then tested as candidate variables into a stepwise Cox regression model (conditional backward selection). The regression coefficients of the Cox regression model were multiplied by 2 and rounded in order to obtain easy to use point numbers facilitating the calculation of the score. To avoid overoptimistic results due to model fitting and evaluation in the same dataset, we performed an internal 10-fold cross-validation by means of bootstrap sampling. RESULTS: Median lesion size was 16 mm (12-23) while median number of adenomas was 2.5 (1-3), whereof the number of ACAs was 1.5 (1-2). At 3 years after polypectomy, recurrence was observed in 229 ACAs (19.8%), of which 157 (13.5%) were metachronous neoplasms and 72 (6.2%) local recurrences. Multivariate analysis, after exclusion of the variable "type of resection" due to its collinearity with other predictive factors, confirmed lesion size, number of ACAs and grade of dysplasia as significantly associated to the primary outcome. The score was then built by multiplying the regression coefficients times 2 and the cut-off point 5 was selected by means of a Receiver Operating Characteristic curve analysis. In particular, 248 patients with 365 ACAs fell in the higher-risk group (score ≥ 5) where 3-year recurrence was detected in 174 ACAs (47.6%) whereas the remaining 595 patients with 690 ACAs were included in the low-risk group (score < 5) where 3-year recurrence rate was 7.9% (55/690 ACAs). Area under the curve of the model was 0.81 (0.72-0.86) with an overall classification error rate of 0.09. The model was finally validated by means of 10-fold cross validation. CONCLUSION: Our study provides support for the use of a novel risk score as a clinical predictor of ACA recurrence after colon polypectomy.

Non-polypoid colorectal neoplasms: Classification, therapy and follow-up.

In the last years, an increasing interest has been raised on non-polypoid colorectal tumors (NPT) and in particular on large flat neoplastic lesions beyond 10 mm tending to grow laterally, called laterally spreading tumors (LST). LSTs and large sessile polyps have a greater frequency of high-grade dysplasia and local invasiveness as compared to pedunculated lesions of the same size and usually represent a technical challenge for the endoscopist in terms of either diagnosis and resection. According to the Paris classification, NPTs are distinguished in slightly elevated (0-IIa, less than 2.5 mm), flat (0-IIb) or slightly depressed (0-IIc). NPTs are usually flat or slightly elevated and tend to spread laterally while in case of depressed lesions, cell proliferation growth progresses in depth in the colonic wall, thus leading to an increased risk of submucosal invasion (SMI) even for smaller neoplasms. NPTs may be frequently missed by inexperienced endoscopists, thus a careful training and precise assessment of all suspected mucosal areas should be performed. Chromoendoscopy or, if possible, narrow-band imaging technique should be considered for the estimation of SMI risk of NPTs, and the characterization of pit pattern and vascular pattern may be useful to predict the risk of SMI and, therefore, to guide the therapeutic decision. Lesions suitable to endoscopic resection are those confined to the mucosa (or superficial layer of submucosa in selected cases) whereas deeper invasion makes endoscopic therapy infeasible. Endoscopic mucosal resection (EMR, piecemeal for LSTs > 20 mm, en bloc for smaller neoplasms) remains the first-line therapy for NPTs, whereas endoscopic submucosal dissection in high-volume centers or surgery should be considered for large LSTs for which en bloc resection is mandatory and cannot be achieved by means of EMR. After piecemeal EMR, follow-up colonoscopy should be performed at 3 mo to assess resection completeness. In case of en bloc resection, surveillance colonoscopy should be scheduled at 3 years for adenomatous lesions ≥ 1 cm, or in presence of villous features or high-grade dysplasia patients (regardless of the size), while less intensive surveillance (colonoscopy at 5-10 years) is needed in case of single (or two) NPT < 1 cm presenting tubular features or low-grade dysplasia at histology.

Endoscopic submucosal dissection vs endoscopic mucosal resection for early gastric cancer: A meta-analysis.

AIM: To compare endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) for early gastric cancer (EGC). METHODS: Computerized bibliographic search was performed on PubMed/Medline, Embase, Google Scholar and Cochrane library databases. Quality of each included study was assessed according to current Cochrane guidelines. Primary endpoints were en bloc resection rate and histologically complete resection rate. Secondary endpoints were length of procedure, post-treatment bleeding, post-procedural perforation and recurrence rate. Comparisons between the two treatment groups across all the included studies were performed by using Mantel-Haenszel test for fixed-effects models (in case of low heterogeneity) or DerSimonian and Laird test for random-effects models (in case of high heterogeneity). RESULTS: Ten retrospective studies (8 full text and 2 abstracts) were included in the meta-analysis. Overall data on 4328 lesions, 1916 in the ESD and 2412 in the EMR group were pooled and analyzed. The mean operation time was longer for ESD than for EMR (standardized mean difference 1.73, 95%CI: 0.52-2.95, P = 0.005) and the "en bloc" and histological complete resection rates were significantly higher in the ESD group [OR = 9.69 (95%CI: 7.74-12.13), P < 0.001 and OR = 5.66, (95%CI: 2.92-10.96), P < 0.001, respectively]. As a consequence of its greater radicality, ESD provided lower recurrence rate [OR = 0.09, (95%CI: 0.05-0.17), P < 0.001]. Among complications, perforation rate was significantly higher after ESD [OR = 4.67, (95%CI, 2.77-7.87), P < 0.001] whereas the bleeding incidences did not differ between the two techniques [OR = 1.49 (0.6-3.71), P = 0.39]. CONCLUSION: In the endoscopic therapy of EGC, ESD showed a superior efficacy but higher complication rate with respect to EMR.