Total and individual PBC-40 scores are reliable for the assessment of health-related quality of life in Greek patients with primary biliary cholangitis.

Background: Primary biliary cholangitis (PBC) has been long associated with impairment of various aspects of health-related quality of life (HRQoL) with substantial differences among populations. This study evaluated for the first-time the HRQoL in Greek PBC patients in conjunction with clinical and laboratory parameters of patients. Methods: We analyzed prospectively collected data regarding the HRQoL by using the PBC-40 and SF-36 questionnaires in 374 Greek PBC patients and 131 age- and sex-matched non-PBC controls. Results: The PBC-40 questionnaire is a reliable tool for HRQoL assessment in Greek PBC patients (Cronbach's α > 0.7 for all domains). Implementation of PBC-40 and SF-36 demonstrated significant impairment of HRQoL in Greek PBC patients compared to controls (P < 0.001 for all comparisons). Emotional dysfunction, social impairment, and fatigue (100%, 80.5% and 78%, respectively) were amongst those with the highest, while cognitive dysfunction (32%) with the least impact on quality of life. Fatigue was associated with female sex (P = 0.02), longer disease duration (P = 0.01), presence of cirrhosis (P = 0.02) and positivity for PBC-specific ANA (P < 0.05), while social dysfunction with increased age (P < 0.001), longer disease duration (P < 0.001) and presence of cirrhosis (P = 0.004). Living in urban areas was linked to impaired social function (P = 0.04), cognition (P = 0.02), fatigue (P = 0.04) and increased total PBC-40 score (P = 0.01). Conclusions: Implementation of PBC-40 and SF-36 revealed impaired HRQoL in Greek PBC patients with fatigue, social and emotional dysfunction exerting the highest impact. However, total, and individual PBC-40 scores were lower than that reported in studies from Northern/Central Europe and Canada. Deranged HRQoL was associated with severity of liver disease and presence of PBC-specific ANA.

Endoscopic full-thickness resection of colorectal lesions with the full-thickness resection device: clinical experience from two referral centers in Greece.

BACKGROUND: Endoscopic full-thickness resection (EFTR) using the full-thickness resection device (FTRD®) is an invasive treatment for colorectal lesions not resectable by conventional endoscopic techniques. This study presents the first Greek experience of the FTRD® procedure, assessing the efficacy and safety of EFTR. METHODS: We conducted a retrospective analysis of 17 consecutive patients treated with the FTRD® at 2 referral centers from October 2015 through December 2018. The indications included difficult adenomas (non-lifting and/or at difficult locations), early adenocarcinomas and subepithelial tumors. Primary endpoints were technical success and R0 resection. RESULTS: Technical success and R0 resection were achieved in 82.3% procedures (14/17) and in 87.5% of those with difficult adenomas (8 patients). In the subgroup with carcinomas (n=3), the rate of technical success and R0 resection was 66.6%, while in the subgroup with subepithelial tumors (n=6) the rate was 83.3%. Technical success and R0 resection were significantly lower for lesions >20 mm vs. ≤20 mm (P=0.0429). In the 17 patients a total of 3 adverse events occurred (17.6%) and one of the patients underwent laparoscopic appendectomy because of EFTR around the appendix. CONCLUSIONS: Our study showed favorable results concerning EFTR feasibility, efficacy and safety, especially for lesions ≤20 mm, non-lifting adenomas, and subepithelial tumors. Technical success, R0 resection, and adverse events rates were comparable with previously published data. Larger randomized studies are needed to better define the clinical benefit and long-term outcomes of EFTR in selected patients.

Prevalence of Clostridium difficile infection among hospitalized inflammatory bowel disease patients in Greece.

BACKGROUND: Inflammatory bowel disease (IBD) is an independent risk factor for Clostridium difficile infection (CDI), which is associated significantly with disease severity. We aimed to determine the rates of CDI among hospitalized IBD patients in major tertiary referral hospitals in Greece. PATIENTS AND METHODS: A retrospective analysis was carried out of stool cultures from hospitalized patients investigated for diarrhea, during 2016, tested for CDI with glutamate dehydrogenase (GDH) and toxins A and B. RESULTS: In total, 6932 patients were tested for CDI; 894 were positive for GDH (12.89%) and 339 were also positive for C. difficile toxin (4.89%). The prevalence of CDI among all hospitalized patients was 1.6/1000 patient-days. Among these, there were 401 IBD patients, and 62 were positive for GDH (15.46%) and 30 were also positive for C. difficile toxin (7.48%). The prevalence of CDI in IBD patients was 2.5/1000 patient-days, significantly higher than in non-IBD hospitalized patients (30/401 vs. 309/6531, P=0.013). Among the 30 IBD patients (ulcerative colitis=18, Crohn's disease=12) with CDI, six were receiving biologics, three were on corticosteroids [one combined with azathioprine (AZA) and one combined with 5-ASA], nine were on AZA monotherapy and 12 were on 5-ASA monotherapy. The prevalence of CDI among patients receiving AZA monotherapy was significantly higher than in patients receiving other medications (9/68 vs. 21/333, P=0.047). Mild CDI (n=28) was treated with metronidazole and/or vancomycin, whereas severe CDI (n=2) was treated with vancomycin. CONCLUSION: The prevalence of CDI is higher in hospitalized IBD patients than those without IBD and AZA monotherapy increases the risk of CDI.

Complete endoscopic mucosal resection of malignant colonic sessile polyps and clinical outcome of 51 cases.

BACKGROUND: Meta-analyses and guidelines recommend that deep submucosal invasion (>1 mm) of malignant sessile colonic polyps is an important risk factor for lymph node metastasis. However, existing data are based on small retrospective studies with marked heterogeneity. We herein aimed to investigate the long-term outcomes of patients who underwent complete endoscopic mucosal resection (EMR) of malignant colonic sessile polyps invading the submucosal layer. METHODS: Endoscopy records for the period 2000-2016 were reviewed retrospectively. All enrolled patients exhibited an endoscopically resected malignant colonic sessile polyp. All patients were advised to undergo surgery, but some opted for conservative treatment and endoscopic follow up. RESULTS: Fifty-one patients with confirmed infiltrative submucosal adenocarcinoma in sessile colonic polyps that had undergone complete EMR were detected. A total of 32 (62.7%) patients opted for surgery after EMR and 19 (37.3%) chose endoscopic follow up. In 44 (86.3%) patients the submucosal invasion was >1 mm. Residual malignant disease was identified in the surgical pathological specimen of only 1 patient. During a median follow up of 23.41 months (interquartile range 33.45, range 1.84-144.92), no local recurrences or lymph node metastasis were identified. Forty-nine patients are alive without evidence of disease and 2 died of other causes (without evidence of local or metastatic disease at last follow up). CONCLUSION: Our data suggest that complete EMR of cancerous colonic sessile polyps, even in cases of submucosal invasion >1 mm carries a low risk of recurrence and therefore may need further evaluation as an alternative strategy to surgical resection.

Comparison of digital versus fiberoptic cholangioscopy in patients requiring evaluation of bile duct disease or treatment of biliary stones.

BACKGROUND: Recently, the introduction of the novel digital SpyGlass™ DS Direct Visualization system (Boston Scientific Corp., Natick, MA, USA) has signaled the transition into the era of digital single-operator cholangioscopy (D-SOC). We sought to compare the clinical utility between fiberoptic single-operator cholangioscopy (F-SOC) and D-SOC in a tertiary-care referral center in Greece. METHODS: This was a retrospective analysis of a prospective database of single-operator cholangioscopy (SOC) procedures performed over an 8-year period (2009-2017) at a single tertiary-care referral center. The study population consisted of consecutive adults referred for cholangioscopy for a variety of clinical indications, including biliary strictures, difficult biliary stones and migrated or occluded pancreatic or biliary stents. RESULTS: A total of 2763 endoscopic retrograde cholangiopancreatography procedures were performed during the study period. Overall, SOC was performed in 68 (2.46%) procedures (F-SOC=39, D-SOC=29), showing a significant increase in the utilization of cholangioscopy during the D-SOC (29/599; 4.84%) compared with the F-SOC (39/2124; 1.83%) period (P=0.0001). The overall technical success of diagnostic SOC was 69.1% (38/55), being marginally higher for D-SOC (83.3%) than for F-SOC (58.1%), although not reaching statistical significance (P=0.07). CONCLUSIONS: D-SOC was utilized more frequently in our tertiary-care non-academic referral center, demonstrating a favorable safety profile and a trend towards a marginally higher technical success rate for the diagnosis of biliary strictures compared with F-SOC.

Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial.

BACKGROUND AND STUDY AIMS: Cold snare polypectomy is an established method for the resection of small colorectal polyps; however, significant incomplete resection rates still leave room for improvement. We aimed to assess the efficacy of cold snare endoscopic mucosal resection (CS-EMR), compared with hot snare endoscopic mucosal resection (HS-EMR), for nonpedunculated polyps sized 6 - 10 mm. PATIENTS AND METHODS: This study was a dual-center, randomized, noninferiority trial. Consecutive adult patients with at least one nonpedunculated polyp sized 6 - 10 mm were enrolled. Eligible polyps were randomized (1:1) to be treated with either CS-EMR or HS-EMR. Both methods involved submucosal injection of a methylene blue-tinted normal saline solution. The primary noninferiority end point was histological eradication evaluated by postpolypectomy biopsies (noninferiority margin - 10 %). Secondary outcomes included occurrence of intraprocedural bleeding, clinically significant postprocedural bleeding, and perforation. RESULTS: Among 689 patients screened, 155 patients with 164 eligible polyps were included (CS-EMR n = 83, HS-EMR n = 81). The overall rate of histological complete resection was 92.8 % in the CS-EMR group and 96.3 % in the HS-EMR group (difference 3.5 %; 95 % confidence interval [CI] - 4.15 to 11.56), showing noninferiority of CS-EMR compared with HS-EMR. CS-EMR was shown to be noninferior both for polyps measuring 6 - 7 mm (CS-EMR 93.3 %; HS-EMR 100 %; 95 %CI - 7.95 to 21.3) and those of 8 - 10 mm (92.5 % vs. 94.7 %, respectively; 95 %CI - 7.91 to 13.16). Rates of intraprocedural bleeding were similar between the two groups (CS-EMR 3.6 %, HS-EMR 1.2 %; P  = 0.30). No clinically significant postprocedural bleeding or perforation occurred in either group. CONCLUSIONS: CS-EMR appears to be a valuable modification of the standard cold snare technique, obviating the need to use diathermy for nonpedunculated colorectal polyps sized 6 - 10 mm.