Photochemical Internalization of Gemcitabine Is Safe and Effective in Locally Advanced Inoperable Cholangiocarcinoma.

BACKGROUND: Photochemical internalization (PCI) is a novel technology for light-induced enhancement of the local therapeutic effect of cancer drugs, utilizing a specially designed photosensitizing molecule (fimaporfin). The photosensitizing molecules are trapped in endosomes along with macromolecules or drugs. Photoactivation of fimaporfin disrupts the endosomal membranes so that drug molecules are released from endosomes inside cells and can reach their therapeutic target in the cell cytosol or nucleus. Compared with photodynamic therapy, the main cytotoxic effect with PCI is disruption of the endosomal membrane resulting in delivery of chemotherapy drug, and not to the photochemical reactions per se. In this study we investigated the effect of PCI with gemcitabine in patients with inoperable perihilar cholangiocarcinoma (CCA). METHODS: The in vitro cytotoxic effect of PCI with gemcitabine was studied on two CCA-derived cell lines. In a fimaporfin dose-escalation phase I clinical study, we administered PCI with gemcitabine in patients with perihilar CCA (n = 16) to establish a safe and tolerable fimaporfin dose and to get early signals of efficacy. The patients enrolled in the study had tumors in which the whole length of the tumor could be illuminated from the inside of the bile duct, using an optical fiber inserted via an endoscope (Fig. 1). Fimaporfin was administered intravenously at day 0; gemcitabine (i.v.) and intraluminal biliary endoscopic laser light application on day 4; followed by standard gemcitabine/cisplatin chemotherapy. RESULTS: Preclinical experiments showed that PCI enhanced the effect of gemcitabine. In patients with CCA, PCI with gemcitabine was well tolerated with no dose-limiting toxicities, and no unexpected safety signals. Disease control was achieved in 10 of 11 evaluable patients, with a clearly superior effect in the two highest dose groups. The objective response rate (ORR) was 42%, including two complete responses, while ORR at the highest dose was 60%. Progression-free survival at 6 months was 75%, and median overall survival (mOS) was 15.4 months, with 22.8 months at the highest fimaporfin dose. CONCLUSION: Photochemical internalization with gemcitabine was found to be safe and resulted in encouraging response and survival rates in patients with unresectable perihilar CCA.

Endoscopic and percutaneous biliary interventions in patients with altered upper gastrointestinal anatomy-the Munich Multicenter Experience.

BACKGROUND: In patients with altered upper gastrointestinal anatomy, conventional endoscopic retrograde cholangiography is often not possible and different techniques, like enteroscopy-assisted or percutaneous approaches are required. Aim of this study was to analyze success and complication rates of these techniques in a large collective of patients in the daily clinical practice in a pre-endosonographic biliary drainage era. PATIENTS AND METHODS: Patients with altered upper gastrointestinal anatomy with biliary interventions between March 1st, 2006, and June 30th, 2014 in four tertiary endoscopic centers in Munich, Germany were retrospectively analyzed. RESULTS: At least one endoscopic-assisted biliary intervention was successful in 234/411 patients (56.9%)-in 192 patients in the first, in 34 patients in the second and in 8 patients in the third attempt. Success rates for Billroth-II/Whipple-/Roux-en-Y reconstruction were 70.5%/56.7%/49.5%. Complication rates for these reconstructions were 9.3%/6.5%/6.3%, the overall complication rate was 7.1%. Success rates were highest in patients with Billroth-II reconstruction where use of a duodenoscope was possible, complication rates were also highest in this scenario. Success rates were lowest in longer-limb anatomy like Roux-en-Y reconstruction. Percutaneous biliary drainages (PTBD) were inserted 268 times with substantially higher success (90.7%) as well as complication rates (11.6%) compared to the endoscopic approach. Compared to patients treated endoscopically, patients with PTBD had a lower performance status, more severe cholestasis and a significant higher rate of malignant underlying disease. CONCLUSION: In patients with altered upper gastrointestinal anatomy, success rates of endoscopic-assisted biliary interventions are lower compared to PTBD. Still, due to the beneficial complication rates of the endoscopic approach, this technique should be preferred whenever possible and in selected patients who still need to be defined in detail, repeated endoscopic attempts are useful to help achieve the desired result.

Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial.

BACKGROUND & AIMS: Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, rates of inadequate preparation are still high. We investigated the effects of reinforced patient education using a smartphone application software (APP) for colonoscopy preparation in participants in a CRC screening program. METHODS: We performed a prospective, endoscopist-blinded study of 500 patients undergoing split-dose bowel preparation for CRC screening or surveillance colonoscopies at multiple centers in Germany, from November 2017 through January 2019. Participants (n = 500) were given oral and written instructions during their initial appointment and then randomly assigned (1:1) to groups that received reinforced education starting 3 days before the colonoscopy (APP group) or no further education (controls). The primary outcome was quality of bowel preparation according to the Boston bowel preparation scale. Secondary outcomes included polyp and adenoma detection rates, compliance with low-fiber diet, split-dose laxative intake, perceived discomfort from the preparation procedure. RESULTS: The mean Boston bowel preparation scale score was significantly higher in the APP-group (7.6 ± 0.1) than in the control group (6.7 ± 0.1) (P < .0001). The percentage of patients with insufficient bowel preparation was significantly lower in the APP group (8%) than in the control group (17%) (P = .0023). The adenoma detection rate was significantly higher in the APP group (35% vs 27% in controls) (P = .0324). Use of the APP was accompanied by a lower level of non-compliance with correct laxative intake (P =.0080) and diet instructions (P = .0089). The APP group reported a lower level of discomfort during preparation (P < .0001). CONCLUSIONS: In a randomized trial, reinforcing patient education with a smartphone application optimized bowel preparation in the 3 days before colonoscopy, increasing bowel cleanliness, adenoma detection, and compliance in patients undergoing CRC screening or surveillance. ClinicalTrials.gov no: NCT03290157.

Risk factors for bleeding from gastrointestinal angiodysplasia: a case-control study in patients with bleeding and non-bleeding angiodysplasia.

OBJECTIVES: Angiodysplasia (AD) is a common source of gastrointestinal bleeding. Yet, little is known about factors forwarding bleeding in these vascular malformations. The presented study aims to determine risk factors for bleeding that occurs only in patients with symptomatic, but not with asymptomatic, AD. METHODS: Case-control study in patients with AD and either a positive or a negative history of gastrointestinal bleeding in Munich, Germany. Groups were compared by clinical, laboratory, and endoscopic features. RESULTS: 80 patients with (58, f 31, med. age 72) or without bleeding AD (22, f 12, med. age 61) were included. Bleeding from AD was significantly associated with the total number of AD (OR 1.4 (95 % CI 1.1-1.7) p = 0.01) and closure time in PFA/collagen-epinephrine test (OR 1.0 (95 % CI 1.0-1.0) p < 0.01). The total number of AD correlated significantly with age (r = 0.36; p = 0.01). AD were mainly detected in the upper small intestine (> 30 %). Although patients with aortic stenosis suffered not significantly more frequently from bleeding from AD, they demonstrated a loss of high molecular multimers of VWF. CONCLUSIONS: The amount of AD is clearly correlated to the age of the patient. A higher number of ADs and inhibition of primary hemostasis increase the risk of bleeding.

Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II).

BACKGROUND AND AIMS: Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, the rates of inadequate preparation are still high. We investigated the effects of reinforcing patient education and guidance by using the short message service (SMS). METHODS: In this prospective, endoscopist-blinded, multicenter study, standard instructions pertaining to split-dose preparation were provided in a verbal and written format to all patients during the initial appointment. Patients were randomly assigned (1:1) to a group that received reinforced education starting 4 days before the colonoscopy (SMS group) or to the control group which did not receive further education. The primary outcome was the percentage of insufficient preparation results (Boston Bowel Preparation Scale [BBPS] score <6). The secondary outcomes included quality of bowel preparation according to the BBPS, polyp and adenoma detection rates, and patients' perceived discomfort in the preparation procedure. RESULTS: The percentage of patients with insufficient bowel preparation was significantly lower in the SMS group (9%) than in the control group (19%) (P = .0013). The mean BBPS score was significantly higher in the SMS group (7.4 ± 0.1) than in the control group (6.5 ± 0.1) (P < .0001). Each colon segment had significantly higher BBPS scores in the SMS group. The adenoma detection rate and number of detected adenomas in the right segment of the colon were higher in the SMS group. SMS messages were accompanied by a lower level of discomfort during preparation (numeric rating scale) (5.2 SMS vs 5.8 controls) (P = .0042). CONCLUSIONS: Reinforced patient education by using SMS messages during the 4 days before colonoscopy increased bowel cleanliness, adenoma detection in the right segment of the colon, and reduced discomfort. (Clinical trial registration number: NCT02272036.).

Treatment of Refractory Adrenocortical Carcinoma with Thalidomide: Analysis of 27 Patients from the European Network for the Study of Adrenal Tumours Registry.

OBJECTIVE: Adrenocortical carcinoma (ACC) is a rare malignancy with a dismal prognosis. In advanced stages, tumour control by mitotane and cytotoxic chemotherapy is often temporary and salvage treatments are warranted. METHODS: Retrospective cohort study of participants in the prospective European Networks for the Study of Adrenal Tumours (ENSAT) registry. Main outcome measures were best response during treatment, progression-free survival (PFS), both measured according to RECIST 1.1 by two blinded radiologists, and overall survival (OS). RESULTS: Twenty-seven patients (13 males; median age 44.1 years) progressing after mitotane and a median of 4 further systemic treatments were included. Thalidomide was administered as tolerated with a starting dose of 50 mg and target dose of 200 mg /d. The median interval between treatment initiation and first imaging was 10.5 (4.4-17.5) weeks. The best response to treatment was stable disease (SD, n=2) and progressive disease (n=25), with a median PFS of 11.2 weeks and a median OS of 36.4 weeks. The first patient with SD discontinued treatment due to mild epistaxis and diarrhea after 22.3 weeks. The second patient had SD at the second treatment evaluation after 25.2 weeks and continued thalidomide but then had clinical progression and deceased after 54.3 weeks. In general, thalidomide induced only mild or moderate adverse effects (mainly fatigue and gastrointestinal complaints). CONCLUSION: Thalidomide was overall well tolerated but resulted in disease control in only 2/27 (7.4%) patients. In the absence of predictive response markers, thalidomide should only be considered in exceptional cases as a salvage therapy in ACC.

Comparison of Ultrasound and Fluoroscopically Guided Percutaneous Transhepatic Biliary Drainage.

BACKGROUND: Percutaneous transhepatic biliary drainage (PTBD) plays a significant role especially in the palliation of an endoscopically inaccessible biliary system. Since a standard technique of PTBD is not defined, we compared a fluoroscopically guided technique (F-PTBD) with an ultrasound (US-PTBD) guided approach. PATIENTS AND METHODS: Procedure characteristics, success-rates and complication-rates of the different PTBD techniques were compared in patients who underwent PTBD between October 1, 2006, and -December 31, 2014. RESULTS: In 195 patients, 251 PTBDs (207 F-PTBDs, 44 US-PTBDs) were performed. F-PTBDs were mostly inserted from the right and US-PTBDs from the left. Patient age, gender and physical status were comparable in both techniques. There was no difference regarding overall procedure success (90%/86.4%), overall interventional complication rates (10.6%/9.1%), fluoroscopy times, intervention times or sedatives dosages. However, major complications were only encountered in F-PTBDs. There was a higher success rate for F-PTBD vs. US-PTBD from the right side (91.9 vs. 75%; p = 0.033) and a trend towards a higher success rate for US guidance from the left side (82.9 vs. 95.8%; p = 0.223). CONCLUSIONS: For drainage of the right biliary system F-PTBD seems superior over the US-PTBD technique used in this study. However, major complications can occur more frequently in F-PTBD.

Management of occluded self-expanding biliary metal stents in malignant biliary disease.

BACKGROUND: Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. METHODS: Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. RESULTS: A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). CONCLUSIONS: In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management strategy.

Predictors and characteristics of angioectasias in patients with obscure gastrointestinal bleeding identified by video capsule endoscopy.

BACKGROUND: In obscure gastrointestinal bleeding, angioectasias are common findings in video capsule endoscopy (VCE). OBJECTIVE: The objective of this study was to identify predictors and characteristics of small bowel angioectasias. METHODS: Video capsule examinations between 1 July 2001 and 31 July 2011 were retrospectively reviewed. Patients with obscure gastrointestinal bleeding were identified, and those with small bowel angioectasia were compared with patients without a definite bleeding source. Univariate and multivariable statistical analyses for possible predictors of small bowel angioectasia were performed. RESULTS: From a total of 717 video capsule examinations, 512 patients with obscure gastrointestinal bleeding were identified. Positive findings were reported in 350 patients (68.4%) and angioectasias were documented in 153 of these patients (43.7%). These angioectasias were mostly located in the proximal small intestine (n = 86, 56.6%). Patients' age >65 years (odds ratio (OR) 2.15, 95% confidence interval (CI) 1.36-3.38, p = .001) and overt bleeding type (OR 1.89, 95% CI 1.22-2.94, p = .004) were identified as significant independent predictors of small bowel angioectasia. CONCLUSION: Angioectasias are the most common finding in VCE in patients with obscure gastrointestinal bleeding. They are mostly located in the proximal small bowel and are associated with higher age and an overt bleeding type.

Dynamics of Adrenocorticotropin after Application of Metyrapone.

Purpose: To investigate the kinetics of adrenocorticotropin (ACTH) following oral metyrapone administration and describe differences between ACTH-deficient and non-ACTH-deficient subjects. Methods: Patients from a tertiary endocrine center at a University Hospital in Munich, Germany, were tested for secondary adrenal insufficiency in a regular patient care setting. Metyrapone (Metopirone, HRA Pharma, France) was administered with a dosage of 40 mg/kg bodyweight at 8 a.m. Consecutive levels of ACTH were determined at 0, 60, 120, 180, and 240 min. Patients were categorized according to their need of glucocorticoid substitution in the follow-up phase. Results: A significant rise in ACTH concentration compared to basal values was found at 60 and 120 min following oral metyrapone administration. ACTH concentrations at 60 and 120 min predicted patients without need for glucocorticoid substitution. ACTH concentrations determined later had no additional benefit. Conclusion: In contrast to previous reports, we found a significant rise in ACTH concentration as soon as one hour after oral metyrapone administration. ACTH values seem to estimate the pituitary corticotrophic function when correlating results to the further clinical course of subjects. Further studies are needed to investigate this finding as a potential basis for a ACTH-based metyrapone short test protocol.

Development and Testing of an Automated 4-Day Text Messaging Guidance as an Aid for Improving Colonoscopy Preparation.

BACKGROUND: In gastroenterology a sufficient colon cleansing improves adenoma detection rate and prevents the need for preterm repeat colonoscopies due to invalid preparation. It has been shown that patient education is of major importance for improvement of colon cleansing. OBJECTIVE: Objective of this study was to assess the function of an automated text messaging (short message service, SMS)-supported colonoscopy preparation starting 4 days before colonoscopy appointment. METHODS: After preevaluation to assess mobile phone usage in the patient population for relevance of this approach, a Web-based, automated SMS text messaging system was developed, following which a single-center feasibility study at a tertiary care center was performed. Patients scheduled for outpatient colonoscopy were invited to participate. Patients enrolled in the study group received automated information about dietary recommendations and bowel cleansing during colonoscopy preparation. Data of outpatient colonoscopies with regular preparation procedure were used for pair matching and served as control. Primary end point was feasibility of SMS text messaging support in colonoscopy preparation assessed as stable and satisfactory function of the system. Secondary end points were quality of bowel preparation according to the Boston Bowel Preparation Scale (BBPS) and patient satisfaction with SMS text messaging-provided information assessed by a questionnaire. RESULTS: Web-based SMS text messaging-supported colonoscopy preparation was successful and feasible in 19 of 20 patients. Mean (standard error of the mean, SEM) total BBPS score was slightly higher in the SMS group than in the control group (7.3, SEM 0.3 vs 6.4, SEM 0.2) and for each colonic region (left, transverse, and right colon). Patient satisfaction regarding SMS text messaging-based information was high. CONCLUSIONS: Using SMS for colonoscopy preparation with 4 days' guidance including dietary recommendation is a new approach to improve colonoscopy preparation. Quality of colonoscopy preparation was sufficient and patients were highly satisfied with the system during colonoscopy preparation.

Salvage Treatment of Adrenocortical Carcinoma with Trofosfamide.

Adrenocortical carcinoma (ACC) has a dismal prognosis in advanced stages. Despite treatment with the adrenal toxicant mitotane and/or aggressive chemotherapy, tumor control is often short-lived. Here, we examine trofosfamide as a salvage treatment of ACC in an observational cohort study within the German ACC registry. Response defined as progression-free survival (PFS) at first tumor evaluation was assessed by RECIST 1.1 or clinically, and PFS and overall survival (OS) were estimated by the Kaplan-Meier method. Twenty-seven patients (11 males; median age 46.9 years) progressing after mitotane and three (median, range 0-5) other systemic treatments were evaluated for safety. Trofosfamide (150 mg/day) was administered as monotherapy (n = 13) or in combination with mitotane (n = 14). Overall tolerability was good with only mild adverse events. Six patients did not meet criteria for response assessment. Of the 21 patients, 8 patients had clinically progressive disease (3 deaths from ACC); among the 13 patients evaluable by RECIST 1.1, best response to treatment was stable disease (SD, n = 3) or progressive disease (n = 10). Hence, predefined response criteria were met in 3/21 patients (14 %). Median PFS was 84 days (95 % confidence interval 74-95) and median OS survival 198 days (95 % CI 89-307). One prolonged disease stabilization (best response by RECIST 1.1 -26 %) was observed for 479 days. In conclusion, trofosfamide is overall well tolerated but disease stabilization is rather rare. Accordingly, it may be used in selected cases of ACC not amenable to other treatment options such as clinical trials.

Microbial colonization of pancreatic duct stents: a prospective analysis.

OBJECTIVE: The aim of the study was to analyze the microbial colonization rate as well as the spectrum and number of microorganisms in relation to the indwelling time of pancreatic stents. METHODS: Forty pancreatic stents were prepared according to a standardized protocol and subsequently sonicated to optimize bacterial release from the biofilm on the stents. RESULTS: Two hundred forty-six microorganisms were identified. Thirty-nine of 40 stents were colonized with microorganisms. Aerobic gram-positive microorganisms (106/246 [43%]) accounted for the greatest proportion. The predominant microorganisms were Streptococcus species (46/246 [19%]), which were isolated from 27 (68%) of 40 stents. Stents with a short indwelling time (3-13 days) were mainly colonized with aerobic gram-positive bacteria (82%) and Candida species (63%). In contrast, anaerobes (P < 0.01, 69% vs 18%) and aerobic gram-negative microorganisms (P < 0.01, 93% vs 45%) such as Enterobacteriaceae (P < 0.01, 86% vs 27%) were significantly more present on stents with a long indwelling time (29-93 days), compared with stents with a short indwelling time. CONCLUSIONS: Microbial analysis of pancreatic duct stents revealed a very high colonization rate. Furthermore, the spectrum and number of microorganisms altered with the indwelling time of the stent. However, clinical relevance of our findings remains unclear.

Trainee colonoscopists fulfil quality standards for the detection of adenomatous polyps.

BACKGROUND: The detection of adenomatous lesions is a major indicator for quality and competence in colonoscopy. Little is known about adenoma detection rates (ADR) of endoscopy trainees. The aim of our study was to investigate the performance of trainee colonoscopists in detecting adenomas and to depict the shape of adenoma detection learning curves during apprenticeship. METHODS: We retrospectively investigated a prospectively maintained database of a single tertiary referral center to reveal colonoscopies performed by trainee endoscopists during 2001 and 2013. Colonoscopy reports were chronologically retrieved and separately analyzed for each trainee. Using cumulative curves, courses of trainee's Adenoma detection rates (ADR) during apprenticeship were displayed. Additionally, procedural data including cecal intubation rate and occurrence of complications were assessed. RESULTS: We retrospectively analyzed 4354 colonoscopies conducted by 10 trainee endoscopists (TE). A median number of 371 investigations were performed by each apprentice. Group ADR was 23%. No significant difference between aggregated ADRs at the beginning (23%) and at the end (22%) of apprenticeship could be determined (p = 0.70). However, individual learning curves showed considerable different slopes. Personal ADR values ranged between 17% and 31%. Overall cecum intubation rate was 99.0 %. Complication rates were low and fulfilled quality requirements recommended in guidelines. CONCLUSION: From the beginning of education, trainee colonoscopists are capable to provide high-quality investigations considering the detection of adenomas as a benchmark quality indicator. Nevertheless, performance differs markedly between investigators. Therefore, individual detection rates should be reviewed regularly to reveal further need for training.

Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results.

BACKGROUND: In mid-GI bleeding, video capsule endoscopy (VCE) shows the best diagnostic yield for ongoing overt bleeding. To date, the utility of VCE in acute severe GI bleeding has been analyzed rarely. OBJECTIVE: To evaluate the impact of VCE when performed on patients with acute severe GI bleeding immediately after an initial negative upper endoscopy result. DESIGN: Prospective study. SETTING: Tertiary-care center. PATIENTS: Patients with melena, dark-red or maroon stool, hemodynamic instability, drop of hemoglobin level ≥2 g/dL/day, and/or need of transfusion ≥2 units of packed red blood cells per day were included. INTERVENTIONS: After a negative upper endoscopy result, emergency VCE was performed by immediate endoscopic placement of the video capsule into the duodenum. MAIN OUTCOME MEASUREMENTS: Rate of patients in whom emergency VCE correctly guided further diagnostic and therapeutic procedures. RESULTS: Upper endoscopy showed the source of bleeding in 68 of 88 patients (77%). In the remaining 20 patients (23%), emergency VCE was performed, which was feasible in 19 of 20 patients (95%; 95% confidence interval [CI], 75%-99%). Emergency VCE correctly guided further diagnostic and therapeutic procedures in 17 of 20 patients (85%; 95% CI, 62%-97%) and showed a diagnostic yield of 75% (95% CI, 51%-91%). LIMITATIONS: Single-center study, small sample size. CONCLUSION: In patients with acute severe GI bleeding and negative upper endoscopy results, emergency VCE can be useful for the immediate detection of the bleeding site and is able to guide further therapy. (Clinical trial registration number: NCT01584869.)

Magnetic endoscope imaging in single-balloon enteroscopy.

BACKGROUND AND AIM: Magnetic endoscope imaging (MEI) provides continuous viewing of the position of the endoscope on a monitor without using X-ray and has already been established for colonoscopy. The aim of the present study was to evaluate a new MEI probe for enteroscopy. METHODS: In this prospective feasibility study, consecutive patients received single-balloon enteroscopy guided by the new MEI probe. Fluoroscopy was also used in all examinations. MEI images were compared to fluoroscopy images with respect to concordance of loop configuration by two independent observers after the examinations. Main outcome measurement was the rate of concordant MEI and fluoroscopy images with respect to loop configuration. RESULTS: In all 10 patients, single-balloon enteroscopy with MEI was carried out without any adverse events or technical difficulties. Concordance of MEI and fluoroscopy images was seen in 36/38 images (95%; 95% CI, 82-99%) by both observers. Overall agreement between the two observers was 95% (κ = 0.47, 95% CI, -0.04-1). CONCLUSION: The use of MEI in single-balloon enteroscopy is safe and feasible. Detection and control of loops can be accurately achieved.

Drainage-related Complications in Percutaneous Transhepatic Biliary Drainage: An Analysis Over 10 Years.

BACKGROUND: Procedure-related complications of percutaneous transhepatic biliary drainage (PTBD) have been well documented in the literature. However, relatively restricted data are available concerning drainage-related complication rates in long-term PTBD therapy. The present retrospective study evaluated the extent and the nature of drainage complications during PTBD therapy and associated risk factors for these complications. PATIENTS AND METHODS: Between June 1997 and May 2007, a total of 385 patients with PTBD were identified by analyzing the PTBD database and hospital charts, with a total of 2468 percutaneous biliary drainages being identified. RESULTS: Among the identified patients, 243 (63%) had malignant and 142 (37%) had benign bile duct strictures. At least 1 drainage-related complication was observed in 40% of the patients. With respect to the total number of drains, prosthesis complications occurred in 23%. Occlusion, dislocation, and cholangitis were the most common complications observed during PTBD therapy. Risk factors for cholangitis and occlusion were malignant disease, prior occurrence of complications, and bilateral drainage. Proximal stenosis of the biliary system was close to significant. CONCLUSIONS: Drainage-related complications are a major problem in PTBD therapy. The risk factors for occlusion and cholangitis discovered in this study can help to refine individual strategies to reduce the rate of these drainage complications.

Biliary endoprosthesis: a prospective analysis of bacterial colonization and risk factors for sludge formation.

Bacterial colonization of biliary stents is one of the driving forces behind sludge formation which may result in stent occlusion. Major focus of the study was to analyze the spectrum and number of microorganisms in relation to the indwelling time of stents and the risk factors for sludge formation. 343 stents were sonicated to optimize the bacterial release from the biofilm and identified by matrix-associated laser desorption/ionization-time of flight mass spectrometer (MALDI-TOF). 2283 bacteria were analyzed in total. The most prevalent microorganisms were Enterococcus species (spp.) (504;22%), followed by Klebsiella spp. (218;10%) and Candida spp. (188;8%). Colonization of the stents mainly began with aerobic gram-positive bacteria (43/49;88%) and Candida spp. (25/49;51%), whereas stents with an indwelling time>60 days(d) showed an almost equal colonization rate by aerobic gram-negative (176/184;96%) and aerobic gram-positive bacteria (183/184;99%) and a high proportion of anaerobes (127/184;69%). Compared to stents without sludge, more Clostridium spp. [(P = 0.02; Odds Ratio (OR): 2.4; 95% confidence interval (95%CI): (1.1-4.9)]) and Staphylococcus spp. [(P = 0.03; OR (95%CI): 4.3 (1.1-16.5)] were cultured from stents with sludge. Multivariate analysis revealed a significant relationship between the number of microorganisms [P<0.01; OR (95%CI): 1.3(1.1-1.5)], the indwelling time [P<0.01; 1-15 d vs. 20-59 d: OR (95%CI): 5.6(1.4-22), 1-15 d vs. 60-3087 d: OR (95% CI): 9.5(2.5-35.7)], the presence of sideholes [P<0.01; OR (95%CI): 3.5(1.6-7.9)] and the occurrence of sludge. Stent occlusion was found in 70/343(20%) stents. In 35% of cases, stent occlusion resulted in a cholangitis or cholestasis. In conclusion, microbial colonization of the stents changed with the indwelling time. Sludge was associated with an altered spectrum and an increasing number of microorganisms, a long indwelling time and the presence of sideholes. Interestingly, stent occlusion did not necessarily lead to a symptomatic biliary obstruction.