Distal Biliary Stent Migration in Patients with Irretrievable Bile Duct Stones: Long-Term Comparison Between Straight and Double-Pigtail Stents.

BACKGROUND: Prolonged biliary stenting may be considered in high-risk patients with irretrievable bile duct stones (IBDS). Distal stent migration (DSM) is a known complication, although data beyond the recommended interval of temporary stenting (3-6 months) are lacking. We compared the long-term incidence of DSM between straight and double-pigtail stents in patients with IBDS. METHODS: Consecutive patients with IBDS undergoing plastic biliary stenting (1/2009-12/2019) were retrospectively reviewed. DSM was confirmed on follow-up examination when the stent was no longer present at the papillary orifice nor fluoroscopically visible in the bile duct. Kaplan-Meier and Cox regression analyses were used to determine estimates and predictors of DSM. RESULTS: Overall, 618 biliary stenting procedures (410 patients) were included: 289 with a straight stent (group A) and 329 with a double-pigtail (group B). By Kaplan-Meier analysis, the DSM rates were 8.4 and 14.6% at 6 months, 21.4 and 27.7% at 12 months, 27 and 43.5% at 18 months, and 37.2 and 60.4% at 24 months, for groups A and B, respectively (p = 0.004). Double-pigtail stents were at higher risk for DSM (HR = 7.38, p = 0.04), whereas an inverse correlation was noted with age (HR = 0.97, p = 0.0001). Considering only temporary stenting procedures (≤ 6 months; n = 297), the probability of DSM was not significantly different between the two groups (p = 0.07). CONCLUSIONS: In a setting of prolonged stenting for IBDS, the probability of DSM appears to be higher when a double-pigtail stent is used and in younger patients. A relative anti-migratory advantage of double-pigtail over straight stents appears negligible in this study.

Long-term recurrence of bile duct stones after endoscopic papillary large balloon dilation with sphincterotomy: 4-year extended follow-up of a randomized trial.

BACKGROUND: Endoscopic papillary large balloon dilation with biliary sphincterotomy (EPLBD + EBS) is safe and effective in patients with large common bile duct (CBD) stones. However, data on long-term outcomes after EPLBD + EBS remain limited. We sought to prospectively evaluate the long-term recurrence of CBD stones after EPLBD + EBS and to identify the associated factors. METHODS: We conducted an extended follow-up of a previous randomized trial (2009-2011) comparing the outcomes of 30- versus 60-s large balloon dilation. A total of 106 trial participants undergoing successful CBD stone clearance by EPLBD + EBS were prospectively followed up for up to 4 years (range 19-48 months). Various risk factors were analysed to assess predictors of long-term recurrence of stones. RESULTS: Recurrent CBD stones appeared in 8/106 (7.5 %) patients during a mean follow-up of 30.5 ± 5.5 months. The mean diameter of CBD was significantly higher in the recurrence versus non-recurrence group (2.0 ± 4.9 vs 1.6 ± 0.9 cm, p = 0.008). Multivariate analysis revealed that CBD diameter was the only predictor significantly associated with the long-term recurrence of stones (odds ratio 1.2, p = 0.01). CONCLUSIONS: EPLBD + EBS is associated with a low rate of long-term CBD stone recurrence. However, the risk is significantly higher in patients with a more dilated CBD.

Endoscopic papillary large-balloon dilation with sphincterotomy for difficult common bile duct stones ≤12 mm: a prospective study.

Background: Stone recurrence is a significant complication following endoscopic bile duct clearance. Endoscopic papillary large-balloon dilation (EPLBD) with biliary sphincterotomy (EBS) has shown satisfactory results in preventing recurrence of "large" common bile duct stones (CBDS). However, data on outcomes after EPLBD+EBS for CBDS ≤12 mm remain scarce. The present study prospectively evaluated the mid- and long-term efficacy of EPLBD+EBS for CBDS recurrence among this group of patients. Methods: Consecutive patients with CBDS ranging from 8-12 mm, treated with EPLBD+EBS from June 2018 through June 2020, were prospectively followed-up for at least 36 months. CBDS recurrence was defined as recurrent stones confirmed by endoscopic retrograde cholangiopancreatography (ERCP) during the follow-up period. Results: Overall, 72 patients (mean age: 67 years, 52.8% male) were included, of whom 22 (30.5%) had multiple (≥3) CBDS, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EBS. The mean CBD diameter was 11.6±1 mm, while a tapered duct was noted in 7 (9.7%). Post-procedural bleeding and cholangitis occurred in 1 and 2 cases respectively. No cases of perforation and post-ERCP pancreatitis were observed. During a mean follow up of 46.4±6.2 months (range 37-60), no mid-term recurrence was observed, whereas CBDS recurred in 2/72 (2.7%) in the long term. Conclusions: EPLBD+EBS in patients with CBDS ≤12 mm was associated with a very low rate of mid- and long-term CBDS recurrence. Our results need to be further investigated with randomized controlled trials.

Cerebral oximetry monitoring in non-intubated patients undergoing endoscopic retrograde cholangiopancreatography under propofol-induced sedation: a prospective observational study.

BACKGROUND: Prolonged propofol-induced deep sedation increases the risk for sedation-related complications. Cerebral oximetry enables prompt assessment of tissue oxygenation by demonstrating the regional hemoglobin oxygen saturation (rSO2) of the cerebral cortex. This study aimed to: evaluate cerebral oxygenation under deep sedation during an endoscopic retrograde cholangiopancreatography (ERCP) procedure; determine the cerebral desaturation event (CDE) rate; and assess the predictive capacity of CDEs for sedation-related complications. METHODS: All consecutive patients who underwent ERCP between September and December 2019 were included prospectively. Propofol monotherapy was used and sedation level was assessed using the bispectral index (BIS). The target level of sedation was deep sedation, defined by BIS values 40-60. Participants were monitored with arterial blood gas analysis and INVOS 5100C cerebral oximeter. RSO2 values were registered prior to sedation (baseline value), every 5 min during the sedation period and at recovery of consciousness. BIS values were recorded simultaneously. CDE was defined as a drop >10% from individual baseline rSO2. RESULTS: Sixty patients were enrolled. Mean baseline rSO2 was 65.1% and BIS values ranged from 18-85. No significant correlation was observed between mean rSO2 measurements and mean BIS values throughout the recordings (P = 0.193). Data from patients aged ≥65 years were analyzed separately and the results were similar. The CDE rate was 2.7%, but no CDE was associated with clinical manifestations. Twelve sedation-related complications occurred without the presence of cerebral desaturation. CONCLUSION: Cerebral oxygenation remained independent of changes in sedation depth and cerebral oximetry monitoring did not detect complications earlier than standard monitors.

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.

Comparative efficacy of nebivolol versus carvedilol on left ventricular function and exercise capacity in patients with nonischemic dilated cardiomyopathy. A 12-month study.

PURPOSE: To compare the efficacy of nebivolol versus carvedilol on left ventricular (LV) function and exercise capacity in patients with nonischemic dilated cardiomyopathy (NIDC). METHODS: After enrollment in this double-blind trial, 72 patients, aged 55 +/- 9.5 years, with NIDC, LV ejection fraction (LVEF) < 45%, New York Heart Association classes II to III, were randomized to either nebivolol (34 patients) or carvedilol (38 patients) and were evaluated through echocardiography and exercise tests at baseline and 3 and 12 months after treatment. RESULTS: During follow-up, 4 patients discontinued nebivolol, although 3 patients stopped carvedilol. Patients in both the nebivolol and carvedilol groups showed a steady improvement in New York Heart Association class (P = .002 and < .001, at 12 months, respectively) and LVEF (P = .001 and < .001, at 12 months, respectively) that became significant from 3-month follow-up on. Intergroup analysis showed that carvedilol group had a greater increase in LVEF at 3 (P = .04) and 12 (P = .02) months' follow-up compared with nebivolol group. Advanced diastolic dysfunction regressed to earlier stages in carvedilol patients after 3 (P = .02) and 12 (P = .01) months' treatment, whereas in the nebivolol group, a significant improvement in diastolic dysfunction was found at the 12 months' follow-up (P = .02). Exercise duration improved in both groups at 12 months' follow-up (both P = .01), but in the nebivolol group, there was an initial deterioration at 3 months (P = .07). CONCLUSIONS: Both nebivolol and carvedilol appear relatively safe, with beneficial effects on LV systolic and diastolic function as well as exercise capacity in patients with NIDC after 12 months' treatment. However, carvedilol exhibits more favorable effects on LV function than does nebivolol.

Use of a double-channel gastroscope reduces procedural time in large left-sided colonic endoscopic mucosal resections.

BACKGROUND/AIMS: Endoscopic mucosal resection (EMR) of large colorectal lesions is associated with increased procedural time. The objective of this study was to evaluate the effect of double-channel gastroscope (DCG) use on the procedural time of EMRs in the rectosigmoid area. METHODS: All EMRs for sessile or flat rectosigmoid lesions ≥2 cm performed between July 2011 and September 2012 were retrospectively analyzed. RESULTS: There were 55 lesions ≥2 cm in the rectosigmoid area in 55 patients, of which 26 were removed by EMR using a DCG (DC group) and 29 by using an ordinary colonoscope or gastroscope (OS group). The mean size of the removed polyps, morphology, adverse effects, and other parameters were similar between the two groups. The mean procedural time was significantly lower in the DC group than in the OS group (24.4±18.3 minutes vs. 36.3±24.4 minutes, p=0.015). Moreover, in a subgroup of patients with polyps >40 mm, the statistical difference in the mean procedural time between the DC and OS groups was even more pronounced (33±21 minutes vs. 58.7±20.6 minutes, p=0.004). CONCLUSIONS: Our data suggest that the use of a DCG in the resection of large nonpedunculated rectosigmoid lesions significantly reduces the procedural time.

Sixty- versus thirty-seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: a randomized controlled trial.

BACKGROUND: Endoscopic biliary sphincterotomy followed by endoscopic papillary balloon dilation is a promising method for large stones. However, there are no data on the optimal duration of papillary balloon dilation after a biliary sphincterotomy. AIMS: To compare the effectiveness and complications of the endoscopic papillary balloon dilation for 60s versus 30s after endoscopic biliary sphincterotomy. METHODS: A total of 124 patients with bile duct stones, submitted for endoscopic biliary sphincterotomy plus endoscopic papillary balloon dilation, were prospectively randomized to either the 60-s dilation group (G60, n = 60) or the 30-s dilation group (G30, n = 64). RESULTS: The complete removal of bile duct stones was similar: group G30, 55/64 (86%) versus group G60, 51/60 (85%); p = 0.9. The rates of post-endoscopic retrograde cholangio-pancreatography pancreatitis were also similar: 2 (3.1%) in group G30 versus 2 (3.3%) in group G60, p = 0.9. Post-procedural bleeding occurred in 2 cases (3.1%) in group G30 versus 4 (6.6%) in group G60, (p = 0.17). Two perforations of moderate severity were observed, one in each group. CONCLUSIONS: 30-s papillary balloon dilation, performed after endoscopic biliary sphincterotomy for the management of bile duct stones, was equally effective to the 60-s papillary balloon dilation.

Sex steroids and personality traits in the middle luteal phase of healthy normally menstruating young professional women.

OBJECTIVE: Sex steroids affect human behavior. The aim of the present study was to determine the associations, if any, between the circulating levels of gonadal and adrenal sex steroids in the mid luteal phase (21st day of a normal menstrual cycle, MC) of young professional women and psychometric parameters as assessed by the Minnesota Multiphasic Personality Inventory (MMPI). RESULTS: Our results are as follows: (a) The metabolic product of activated adrenal and gonadal androgens, 3alpha-diolG, was modestly but significantly associated with the social introversion scale (10-SI) (r=0.36, p<0.05), independently accounting for 13% of its variation across participants (R²=0.13, F(1,45)=6.58, p=0.014). (b) Total testosterone was significantly associated with the paranoia scale (6-Pa) (r=0.27, p<0.05). Multiple regression analyses indicated that 10% of the variability in paranoia scores could be independently explained by total testosterone levels (R²=0.10, F(1,57)=6.23, p=0.016). We were unable to find any association between the circulating androgens and scores on the masculinity-femininity scale (Mf). We were also unable to document any association between the weak adrenal androgens DHEA and DHEA-S and depression in contrast to several published reports. (c) Our data suggest a marginally significant association between progesterone and scores on the 7-Pt (obsessive/compulsive/psychasthenia) scale (r=0.27, p<0.05). However, only 7% of the 7-Pt variance was explained by progesterone (R²=0.071, F(1,50)=3.81, p=0.057). CONCLUSIONS: We have found that total testosterone was associated with the paranoia score, the metabolic product of activated androgens, 3alpha-diolG, to social introversion and, finally, progesterone to obsessive-compulsive behavior.

Remifentanil compared with midazolam and pethidine sedation during colonoscopy: a prospective, randomized study.

PURPOSE: The objective of our study was to compare the safety and efficacy of remifentanil during colonoscopy with those of the standard combination of midazolam and pethidine. METHODS: One-hundred and sixteen consecutive patients scheduled for colonoscopy were randomly assigned to groups A or B. Patients in group A (n = 56) received intravenous (IV) midazolam and pethidine. Patients in group B (n = 60) received IV remifentanil. RESULTS: Recovery was faster in group B (0 min) than in group A (56 +/- 11.3 min) (P < 0.001). There was a marked difference between groups B and A with regard to the time of hospital discharge-28.7 +/- 4.3 and 148.9 +/- 34 min, respectively (P < 0.001). Patients in group A rated the procedure as comfortable, as also did those in group B. A combination of midazolam and pethidine had a greater affect on patients' cardiorespiratory characteristics. CONCLUSION: Remifentanil during colonoscopy provides sufficient pain relief with better hemodynamic stability, less respiratory depression, and significantly faster recovery and hospital discharge than moderate sedation with midazolam and pethidine.

A prospective, randomized comparison of adrenaline injection in combination with detachable snare versus adrenaline injection alone in the prevention of postpolypectomy bleeding in large colonic polyps.

OBJECTIVES: Our study sought to compare the efficacy of adrenaline injection in combination with detachable snare versus adrenaline injection alone in the prevention of postpolypectomy bleeding in large colonic polyps. METHODS: At the time of colonoscopy, patients with at least one colonic polyp > or =2 cm were randomized to receive treatment either by the injection of a 1:10.000 solution of adrenaline and the position of a detachable snare followed by a conventional snare polypectomy (group A) or injection of adrenaline followed by a conventional snare polypectomy (group B). A total of 159 consecutive patients were randomly assigned to one of the above groups. Out of them, 84 patients (47 men, 37 women, mean age 61 yr) were assigned to group A and 75 (37 men, 38 women, mean age 64 yr) to group B. Early (<24 h) and late (>24 h-30 days) bleeding complications were assessed. RESULTS: Overall bleeding complications occurred in 10/159 (6.2%) of the patients. There were two cases of bleeding in group A (2.3%), and eight in group B (10.6%) (P= 0.04). The number of early bleeding episodes was significantly reduced in group A patients (1 case) compared to that of group B (7 cases) (P= 0.02). In contrast, there was no significant difference between group A and B as far as late bleeding is concerned. CONCLUSIONS: Our data suggest that the use of adrenaline injection in combination with detachable snare may significantly decrease the number of early postpolypectomy bleeding episodes in patients with large colonic polyps.

Effects of Nebivolol on left ventricular function and exercise capacity in patients with non-ischaemic dilated cardiomyopathy. A randomised placebo-controlled study.

INTRODUCTION: This study assessed the effects of Nebivolol on left ventricular (LV) function and exercise capacity in patients with non-ischaemic dilated cardiomyopathy (NIDC). METHODS: After enrolment in this double-blind trial, 60 patients, aged 55 +/- 9.5 years, with angiographically proven NIDC, LV ejection fraction (EF) < 45%, NYHA class II-III, were randomised to either Nebivolol (target dose 5 mg) or placebo and were evaluated using echocardiography and exercise tests over 3 months. RESULTS: There were no baseline differences between the 2 groups regarding NYHA class, heart rate (HR), blood pressure (BP), LVEF or other echocardiographic variables. During follow-up, 4 patients in the Nebivolol and 5 in the placebo group discontinued treatment. After 3-months' treatment a significant decrease in NYHA class (p = 0.001), resting HR (p = 0.03), systolic and diastolic BP (both p < 0.001), left atrial diameter (p = 0.01) and LV end-systolic volume (p = 0.046), and an increase in LVEF (p = 0.01) were observed in the Nebivolol group compared to placebo. The atrial contribution to total LV filling (p = 0.007) and the pulmonary venous (PV) systolic wave velocity (p = 0.007) increased, whereas the atrial PV component decreased (p < 0.001) in the Nebivolol patients compared to placebo. Exercise duration decreased at 3 months (p = 0.01) compared to placebo, probably as a result of reduced maximal exercise HR (p < 0.001). CONCLUSIONS: Nebivolol is a safe and well-tolerated drug that improves NYHA class, systolic and diastolic LV function in NIDC patients, although it is associated with a lower maximal exercise duration at 3 months.

A prospective, randomized comparison of 10-Fr versus 7-Fr bipolar electrocoagulation catheter in combination with adrenaline injection in the endoscopic treatment of bleeding peptic ulcers.

OBJECTIVES: Our study compared the efficacy of bipolar electrocoagulation (gold probe) with 10-Fr (group A) versus 7-Fr (group B) catheter after adrenaline injection in the treatment of bleeding peptic ulcers. METHODS: A total of 77 consecutive patients with endoscopic evidence of peptic ulcer with active bleeding or a nonbleeding visible vessel were randomly assigned to one of the above protocols. Thirty-nine patients (31 male, eight female, mean age 62 yr) were included in group A and 38 (28 male, 10 female, mean age 61 yr) in group B. RESULTS: The initial hemostasis rate, rebleeding rate, duration of hospital stay, volume of blood transfused, number of operations needed, and number of deaths were not significantly different between the two groups. The mean number of electrocoagulations and the subsequent mean duration of electrocoagulations were significantly higher in group B patients (7.0 +/- 3.8 and 14.1 +/- 7.6 s, respectively) compared with those of group A (4.6 +/- 2.6 and 9.3 +/- 5.3 s, respectively) (p < 0.01). Multivariate stepwise logistic regression analysis revealed that among sex, age, location of bleeding, ulcer size, endoscopic severity of bleeding, and the size of the gold probes, lesser endoscopic severity of bleeding (chi(2) = 31.1, p < 0.01), large size of the gold probe (chi(2) = 23.9, p < 0.01), and small ulcer size (chi(2) = 13.4, p < 0.01) were the only factors significantly associated with a smaller number of electrocoagulations. CONCLUSIONS: In this study, the use of large-size gold probes was significantly associated with a lower number of electrocoagulations, resulting in the reduction of electrocoagulation duration. However, the clinical relevance of these findings is questionable because the efficacy of both sizes of gold probe after adrenaline injection in the treatment of bleeding peptic ulcers was similar.

Synergistic sedation with midazolam and propofol versus midazolam and pethidine in colonoscopies: a prospective, randomized study.

OBJECTIVE: The aim of our study was to compare the safety and efficacy of the synergistic sedation with a low dose of midazolam combined with propofol versus the standard regimen of midazolam and pethidine for conscious sedation in colonoscopy in a group of patients that included a sufficient number of elderly patients with several comorbidities. METHODS: A total of 120 consecutive patients undergoing colonoscopy in a prospective study were randomly assigned to one of two medication regimens (55 patients were over 65 yr). Patients in group A (n = 64) received i.v. 2 mg (<70 kg b.w.) or 3 mg (>70 kg b.w.) of midazolam and a median dose of 80 mg of propofol (range 40-150). Patients in group B (n = 56) received i.v. a median dose of 5 mg of midazolam (range 3-7) and 75 mg of pethidine (range 50-125). The patient's comfort level was assessed by a 4-point scale 24 h after the procedure. The time to recover from sedation was assessed at 5, 10, and 30 min after the procedure by using the Aldrete score. RESULTS: Multivariate stepwise logistic regression analysis revealed that among sex, age, duration of the test, American Society of Anesthesiologists' Physical Status Classification grade, and the sort of sedation, the synergistic sedation with midazolam and propofol was the only factor associated with a higher level of patient comfort (chi2 = 5.5, p < 0.05). Additional multivariate stepwise logistic regression analysis revealed that among sex, age, duration of the test, American Society of Anesthesiologists' Physical Status Classification grade, and the sort of sedation, the synergistic sedation with midazolam and propofol was the only factor associated with a quicker patient recovery time (chi2 = 24.5, p < 0.01; chi2 = 51.7, p < 0.01; chi2 = 148.4, p < 0.01 for Aldrete in 10 min, 20 min, and 30 min, respectively). The endoscopist's evaluation of patient sedation and cardiorespiratory parameters were similar in both groups and in all age groups. CONCLUSIONS: Our data suggest that the synergistic sedation with a low dose of midazolam combined with propofol was superior to a standard combination of midazolam and the opioid pethidine for colonoscopies as far as the patient comfort and recovery times are concerned.