Introduction & aim: To gather information about how adult patients on home parenteral nutrition (HPN) are monitored after discharge from the hospital.Method: A questionnaire about HPN monitoring practice was circulated to HPN centres in eight European countries through the representative of the ESPEN1 HAN-working group(2). Centres were asked about guidelines, home visits and how monitoring and handling of complications were managed.Results: Fourty-two centres in eight European countries completed the questionnaire: UK n = 14, France n = 9, Belgium n = 4, Italy n = 4, Poland n = 4, Denmark n = 4, Spain n = 2, Germany n = 1. The HPN experience of the centres was in the range 2-30 years. Centres ranged in size from 0 to 125 HPN patients representing a total number of 934 of whom 54% had received HPN for more than 2 years. The primary disease was non-malignant in 90% whilst 10% had been diagnosed with active cancer. Of the centres 92% had a HPN team and 66% had written guidelines for monitoring HPN. Home visits after discharge for monitoring purposes were carried out by 31 of the centres involving the HPN team, general practitioner, community nurse or home care agency. Stable patients on HPN for more than 12 months were monitored at the discharging hospital (73%), at a local hospital (12%), by the General Practitioner (11%) or by a home care agency (4%). Of the centres, 90% reported that the main responsibility for monitoring was assigned to a specific person. The intervals between monitoring visits for the stable HPN patient was in the range 1-6 months, 52% of the centres reported intervals of 2-3 months. In case of complications 76% of centres reported that patients got in touch with the HPN team, 2% the local hospital, 5% the home care agency, and 17% other. Re-admission to hospital was usually to the HPN centre and only occasionally to a local hospital.Conclusion: In Europe a specialised team at the discharging hospital monitors HPN patients and 66% of the centres had some kind of written guidelines. (C) 2006 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Introduction The ESPEN guidelines on long-term (> 3 months) parenteral nutrition recommend the use of tunnelled central venous catheters (CVCs) to minimise the risk of insertion site infection. A developed symptomatic infection of the soft tissue tunnel surrounding a CVC may rapidly become directly life threatening if the infection progresses along the catheter tunnel towards its end inserted into the venous system. This requires immediate management to eliminate infection and limit its effects. Aim To compare two surgical techniques for the treatment of suppurative inflammation of a CVC tunnel: conventional drainage of the infected tissues (surgical technique A) vs. radical en bloc excision of the infected tissues together with the infected central catheter (surgical technique B). Material and methods Seventy-three patients hospitalised due to CVC tunnel phlegmon between April 2004 and May 2014 were included in the retrospective study. Thirty-four (46.5%) patients underwent surgical procedure A and another 39 (53.5%) underwent procedure B. Results The mean duration of antibiotic therapy following procedure A was 8 ±3 days, whereas procedure B required 7 ±2 days of antibiotic therapy (NS). The mean hospitalisation period following procedure B was over 8 days shorter in comparison to that following procedure A (16.54 ±7.59 vs. 24.87 ±10.19, p = 0.009, respectively). Conclusions The surgical treatment of CVC tunnel phlegmon involving radical en bloc excision of suppurated tissues along with the infected CVC shortens hospitalisation, expedites the insertion of a new CVC, and potentially reduces treatment costs.

UNLABELLED Injuries, deformations and tumours of the facial part of skull, oral cavity or neck often hamper or prevent normal food consumption. After surgery of these structures food intake may be decreased due to postoperative wounds, pain, swelling and trismus. The aim of the study was to evaluate nutritional state of patients treated surgically in the craniomaxillo- facial surgery department and determination of factors affecting body weight changes after surgery. MATERIAL AND METHODS The study included 83 patients operated between 2008 and 2010 in the department of cranio-maxillo-facial surgery, due to: maxillo-facial defects (30 individuals), malignant tumours (23 individuals), injuries (19 individuals), benign tumours (11 individuals). The study was prospective. A method of nutrition during the observation period and BMI (Body Mass Index) value on the first day of hospitalization and after 10, 60, 180 days after hospital admission were considered. For statistical analysis of results a general regression analysis was used. RESULTS Significant reduction of BMI was observed in all patients after 10 and 60 days from the start of hospitalization. A significant increase of this parameter was observed between Day 60 and Day 180 of observation, however the BMI values after 180 days were still significantly lower than the baseline. A dependency between these changes and a cause of hospitalization as well as nutrition during and after the stay at hospital has been shown. CONCLUSIONS There is a distinct relationship between the worsening of nutritional state after craniofacial surgery and nutrition during and after hospitalization, and therefore special attention should be paid to the issue of nutrition during this period.

UNLABELLED:Long-term home parenteral nutrition (HPN) is an important factor for cholelithiasis. An individualized nutrition program, trophic enteral nutrition and ultrasound bile ducts monitoring is a necessity in those patients. The aim of the study was to evaluate the usefulness of prophylactic cholecystectomy in patients with asymptomatic cholelithiasis requiring HPN.MATERIAL AND METHODS:292 chronic HPN patients were analyzed in the period from 2005 to 2012. Patients were divided into four groups: A - without cholelithiasis, B - with asymptomatic cholelithiasis, C - urgent cholecystectomy because of cholecystisis caused by gallstones, D - cholecystectomy in patients without cholelithiasis performed during an operation to restore the continuity of the digestive tract. The patients were additionally divided depending on the extent of resection of the small intestine and colon.RESULTS:36.9% of chronic HPN patients had cholelithiasis confirmed using ultrasonographic examination. Cholecystectomy due to acute cholecystitis symptoms was performed in 14.4% of the patients. The remaining 22.6% patients had asymptomatic cholelithiasis. Prophylactic cholecystectomy was performed in 5.5% patients with no signs of cholelcystisis during the planned operation to restore the continuity of the digestive tract.CONCLUSIONS:Cholelithiasis in chronic HPN patients is a frequent phenomenon. It seems useful to perform prophylactic cholecystectomy during primary subtotal resection of the small intestine, because the risk of cholelithiasis in this group of patients is very high.

controls. Results: The patients had an apparently SBS-specific increase in the prevalence of Lactobacilli. Bacteroides (Bac303), Roseburia (EREC) groups increased, and Bifidobacteriaceae (Bac 164) and Enterobacteriaceae (Ebac) groups decreased significantly with Sb therapy in SBS. These changes all represented an alteration towards the distribution seen in the normal controls. The changes in all other microbial groups were not consistent, and the median values did not change significantly. The SBS-specific increase in Lactobacilli demonstrated a tendency to decrease, which was however statistically non-significant. However, probiotic treatment decreased levels of lactic acid from 30, 72 mg/dL to 18, 64 mg/dL, so to the reference value. Conclusions: The composition of colonic microbiota in patients with SBS on long term parenteral nutrition differs significantly from that in healthy persons. Saccharomyces boulardii treatment made the microbiota more similar to healthy controls. Especially strong effects are observed with regard to Bacteroides, Roseburia, Bifidobacteriaceae and Enterobacteriaceae groups. None of these bacterial groups showed complete normalization when compared to healthy controls however. The concentration of plasma lactate fell to reference values after Sb treatment. It is possible that the two-week treatment was insufficient to unravel specific shifts in other bacterial groups or to normalize the main fermentative groups. Longer-term therapeutic studies are necessary for what appears a promising strategy.

Improving the effectiveness of the treatment of critically ill and their longer survival has increased the existence of later complications rarely seen before. Among the hospital-acquired infections such complications include infection of mold fungi. The paper presents difficulties in diagnosing and therapy of Aspergillus mold infections illustrating them with the description of cases when Aspergillus infection occurred during the treatment of critically ill, leading with treatment delay to high mortality.

Purpose: Treatment with teduglutide (TED) promotes intestinal adaptation and absorptive capacity in patients (pts) with intestinal failure associated with short bowel syndrome (SBS-IF). In a 24-wk placebo (PBO)-controlled phase III study (STEPS), TED significantly reduced parenteral nutrition and/or intravenous fluid (PN/IV) volume requirements and number of infusion days in pts with SBS-IF. The primary objective of STEPS-2 was to further assess long-term safety and efficacy of TED in pts with SBS-IF. Methods: This extension study enrolled pts who completed 24 wks of treatment with TED (TED/TED) or PBO (PBO/TED) in STEPS or qualified for STEPS but were not treated because target enrollment numbers were met (NT/TED). For safety analysis, PBO/TED and NT/TED groups were combined (PBO+NT/TED). All pts who completed the study received subcutaneous TED (0.05 mg/kg/d) for ≥24 mo; pts in the TED/TED group received TED for 30 mo. Clinical response was defined as a 20%-100% reduction from baseline in weekly PN/IV volume. Results: Of 88 adults enrolled (TED/TED, n=37; PBO/TED, n=39; NT/TED, n=12), 65 (74%) pts completed the study. At 24 mo, clinical response was achieved by 28/30 (93%) TED/TED pts, 16/29 (55%) PBO/TED pts, and 4/6 (67%) NT/TED pts. Mean PN/IV volume reduction from baseline was 7.6 (66%) L/wk, 3.1 (28%) L/wk, and 4.0 (39%) L/wk in the TED/TED, PBO/TED, and NT/TED groups, respectively. Overall, TED treatment resulted in additional days off PN/IV, with 25/65 (38%) pts achieving ≥3-d/wk reduction (TED/TED, 18/30 [60%] pts; PBO/TED, 5/29 [17%]; NT/TED, 2/6 [33%]). 13/88 (15%) pts, including 10 in the TED/TED group, achieved independence from PN/IV. These pts achieved independence from PN/IV after 24-114 wks of TED treatment. Treatment-emergent adverse events occurred in 84/88 (95%) pts; the most common were abdominal pain (34%), catheter sepsis (28%), and episodes of decreased weight (25%). Twenty-three pts discontinued treatment [16/51 (31%) in PBO+NT/TED and 7/37 (19%) in TED/TED groups]. 64% of pts experienced serious AEs. Conclusion: Long-term treatment with TED resulted in additional, clinically meaningful reductions in PN/IV support. Complete independence from PN/IV support was achieved by a heterogeneous group of pts with SBS-IF who received TED. No unexpected safety signals were detected. These data suggest that long-term TED treatment is associated with continued reductions in PN/IV support, and independence from PN/IV for some pts. This research was funded by NPS Pharmaceuticals, Inc., Bedminster, NJ. Disclosure - Lauren K. Schwartz is a consultant for NPS Pharmaceuticals, Inc. Stephen J. D. O'Keefe is a consultant and has received grant/research support from NPS Pharmaceuticals, Inc. Palle B. Jeppesen has received grant/research support and has been an advisory board member as well as other (site investigator on clinical trials) for NPS Pharmaceuticals, Inc. Marek Pertkiewicz is a consultant as well as other (site investigator on clinical trials) for NPS Pharmaceuticals, Inc. Nader N. Youssef is an employee of NPS Pharmaceuticals, Inc. Ken Fujioka is a consultant for NPS Pharmaceuticals, Inc.

BACKGROUND & AIMS:Although home parenteral nutrition (PN) can save the lives of patients with massive bowel loss that results in short-bowel syndrome and intestinal failure, quality of life is impaired by PN and its complications. We examined the 12-month tolerability and efficacy of teduglutide to reduce PN dependency. METHODS:Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide. We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52. RESULTS:The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4). Both groups had progressive reduction in PN. At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively. Four patients achieved complete independence from PN. CONCLUSIONS:For patients with short-bowel syndrome intestinal failure, the efficacy of teduglutide was maintained over 52 weeks and the safety profile was sufficient for it to be considered for long-term use. Further studies are needed to determine whether these effects will translate into improved quality of life and reduced PN complications. ClinicalTrials.gov number, NCT00172185.

BACKGROUND & AIMSTeduglutide, a glucagon-like peptide 2 analogue, might restore intestinal structural and functional integrity by promoting growth of the mucosa and reducing gastric emptying and secretion. These factors could increase fluid and nutrient absorption in patients with short bowel syndrome with intestinal failure (SBS-IF). We performed a prospective study to determine whether teduglutide reduces parenteral support in patients with SBS-IF.METHODSWe performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily. Parenteral support was reduced if 48-hour urine volumes exceeded baseline values by ≥ 10%. The primary efficacy end point was number of responders (patients with >20% reduction in parenteral support volume from baseline at weeks 20 and 24).RESULTSThere were significantly more responders in the teduglutide group (27/43 [63%]) than the placebo group (13/43 [30%]; P = .002). At week 24, the mean reduction in parenteral support volume in the teduglutide group was 4.4 ± 3.8 L/wk (baseline 12.9 ± 7.8 L/wk) compared with 2.3 ± 2.7 L/wk (baseline 13.2 ± 7.4 L/wk) in the placebo group (P < .001). The percentage of patients with a 1-day or more reduction in the weekly need for parenteral support was greater in the teduglutide group (21/39 [54%]) than in the placebo group (9/39 [23%]; P = .005). Teduglutide increased plasma concentrations of citrulline, a biomarker of mucosal mass. The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n = 2) and placebo (n = 3).CONCLUSIONSTwenty-four weeks of teduglutide treatment was generally well tolerated in patients with SBS-IF. Treatment with teduglutide reduced volumes and numbers of days of parenteral support for patients with SBS-IF; ClinicalTrials.gov Number, NCT00798967.

Background & aims Indications and timing for referral for intestinal transplantation (ITx) were investigated through a review of the literature on home parenteral nutrition (HPN) for benign intestinal failure and a benchmarking to the results of a prospective European survey which evaluated the appropriateness of the current indications for ITx. Methods Manuscripts reporting outcomes of adults and children on HPN were retrieved through a PubMed search. Data from the European survey were compared with those on HPN reported in the literature, and with those on ITx reported by the USA registry and by the Pittsburgh center. Results HPN is a safe treatment with a high probability of survival. The risk of death during HPN is increased by the absence of a specialist team, and appears greater during the early period of treatment. Survival probability is decreased in patients with: age >40 or <2 years, very short bowel remnant, presence of a stoma, chronic intestinal pseudo-obstruction of myopathic origin, systemic sclerosis, radiation enteritis, intra-abdominal desmoids, necrotizing enterocolitis, congenital mucosal diseases. Liver failure is the HPN-related complication with the greatest risk of death. Death related to venous catheter complications is rare. The benchmarking supported the results of the European survey.

Purpose: Teduglutide, a dipeptidyl peptidase-IV degradation-resistant analog of human GLP-2, repairs and restores functional and structural integrity of the intestinal mucosa, increasing villous height and crypt depth. The purpose of this study was to evaluate teduglutide 0.05 mg/kg/d given subcutaneously (SC) when compared with placebo on its ability to reduce the PS volume (IV fluids, nutrients, or both) in SBS-IF subjects dependent on PS. Methods: Eighty-six SBS-IF subjects, dependent on PS for ≥1 year, were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multinational, multi-center, 2-stage study. After an initial optimization/stabilization period of PS and urine volume, subjects were randomized to teduglutide 0.05 mg/kg/d SC or placebo for 24 weeks. A responder was defined as a subject who experienced a 20% to 100% reduction from baseline in weekly PS volume at weeks 20 and 24. The primary efficacy endpoint of the study compared the percentage of responders on teduglutide vs placebo. Results: Seventy-eight SBS-IF subjects completed the study (teduglutide 0.05 mg/kg/d, n=39; placebo, n=39). In intention-to-treat (ITT) population, 63% (27/43) of SBS-IF subjects on teduglutide 0.05 mg/kg/d were responders vs 30% (13/43) receiving placebo (p=0.002). Significant response was seen in the teduglutide subjects as early as week 8 and increased through week 24 compared with placebo in SBS-IF subjects. At week 24, teduglutide reduced mean weekly PS volume by 4.4 L/wk (12.9 L/wk at baseline), whereas PS volume reduction with placebo was 2.3 L/wk (13.2 L/wk at baseline; p≤0.001). Significantly more teduglutide-treated subjects were able to reduce the number of infusion days per week by 1 or more days than placebo (21/39 subjects, 54% vs 9/39 subjects, 23%; p=0.0047). Teduglutide was well tolerated; of the 8 discontinued, 3 of 4 in placebo group and 2 of 4 in teduglutide group were due to adverse events (AEs). AEs were found in 83% (35/42) treated with teduglutide vs 79% (34/43) in subjects treated with placebo. The most common AEs were abdominal pain, nausea, gastrointestinal stoma complications, and abdominal distension. Conclusion: Teduglutide 0.05 mg/kg/d SC, was effective and well tolerated in reducing weekly PS volume. Independence from PS, characterized by fewer days per week of PS infusion, was significantly greater with teduglutide. Disclosure: Dr. O'Keefe - Advisory Board Member: NPS Pharmaceuticals Dr. Jeppesen - Consultant: NPS Pharmaceuticals, Consultant: Nycomed GmbH Dr. Pertkiewicz - Consultant: NPS Pharmaceuticals, Member of Advisory Board: Nutricia Scientific Foundation, Lectures at Teaching Workshops Dr. Seidner - Grant/Research Support: NPS Pharmaceuticals, Consultant: Abbott Laboratories, Consultant: B. Braun Dr. Heinze - Employee: Nycomed GmBH Dr. Joelsson - Employee: NPS Pharmaceuticals.

Purpose: TED, a dipeptidyl peptidase-IV degradation-resistant analog of human GLP-2, helps to restore functional and structural integrity of the intestinal mucosa. In a 24-week, placebo-controlled, phase 3 trial, significant mean PS volume reduction of 4.4 L/wk for TED vs 2.3 L/wk for placebo (PLA) was achieved in patients with SBS-IF (STEPS). STEPS2 is an openlabel, multi-center, multi-national, 2-year study that examines TED 0.05mg/kg/day for subjects who had participated in STEPS. The primary objective of this study is to collect long-term safety and tolerability data. In addition, PS volume changes from STEPS baseline continue to be monitored. Methods: 76 of the 78 subjects who completed STEPS enrolled in STEPS2. 37 subjects had received TED while 39 had received PLA. Baseline PS volume was 12.9 L/wk and 13.21 L/wk for the TED and PLA, respectively. Additionally, 12 subjects (baseline PS volume 13.3 L/wk) who completed optimization and stabilization in STEPS had direct rollover into STEPS2. These preliminary interim results of tolerability and presence of TED antibodies are based on subjects who have completed at least month 6 in STEPS2. Results: 12 subjects have discontinued from the extension trial, 9 for an adverse event (AE). The most commonly reported AEs are gastrointestinal (22%, consisting of abdominal pain, distension, nausea, vomiting), general disorder (13%, consisting of edema, injection site-related events such as swelling and redness, pyrexia), and infection (12%, consisting of catheter related infections, urinary tract infection, viral infection). The type frequency and intensity of AEs was not different when compared to results of STEPS. Reductions in PS volume continue to be observed in study participants. 3 subjects (2 TED/TED and 1 PLA/TED, STEPS/STEPS2) have been completely weaned off PS after 6.5, 8, and 9 months of exposure to TED, respectively. To date, no neutralizing antibodies to TED have been observed. Conclusion: This preliminary 6 month assessment of STEPS2 shows continued TED treatment is well tolerated in the majority of subjects. No unexpected safety signal regarding AEs has been observed to date. Further reduction in PS volume was observed in 3 subjects who were completely weaned off of PS. Disclosure: Dr. Schwartz - No financial relationship to disclose Dr. Seidner - Grant/Research Support: NPS Pharmaceuticals, Consultant: Abbott Laboratories, Consultant: B. Braun Dr. Jeppesen - Consultant: NPS Pharmaceuticals, Consultant: Nycomed GmbH Dr. Pertkiewicz - Consultant: NPS Pharmaceuticals, Member of Advisory Board: Nutricia Scientific Foundation, Lectures at Teaching Workshops Dr. Youssef - Employee: NPS Pharmaceuticals Dr. Heinze - Employee: Nycomed GmBH.Table 1: Summary of subjects weaned off of PS STEPS2