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Background: Data on perioperative chemotherapy in resectable pancreatic ductal adenocarcinoma (rPDAC) are limited. NEONAX examined perioperative or adjuvant chemotherapy with gemcitabine plus nab-paclitaxel in rPDAC (National Comprehensive Cancer Network criteria).Patients and methods: NEONAX is a prospective, randomized phase II trial with two independent experimental arms. One hundred twenty-seven rPDAC patients in 22 German centers were randomized 1 : 1 to perioperative (two preoperative and four post-operative cycles, arm A) or adjuvant (six cycles, arm B) gemcitabine (1000 mg/m2) and nabpaclitaxel (125 mg/m2) on days 1, 8 and 15 of a 28-day cycle.Results: The primary endpoint was disease-free survival (DFS) at 18 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neoadjuvant chemotherapy (CTX) (A) or adjuvant CTX (B)]. The predefined DFS rate of 55% at 18 months was not reached in both arms [A: 33.3% (95% confidence interval [CI] 18.5% to 48.1%), B: 41.4% (95% CI 20.7% to 62.0%)]. Ninety percent of patients in arm A completed neoadjuvant treatment, and 42% of patients in arm B started adjuvant chemotherapy. R0 resection rate was 88% (arm A) and 67% (arm B), respectively. Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months (95% CI 19.7-29.7 months) in arm A and 16.7 months (95% CI 11.6-22.2 months) in the upfront surgery arm. This difference corresponds to a median DFS (mDFS) (ITT) of 11.5 months (95% CI 8.8-14.5 months) in arm A and 5.9 months (95% CI 3.6-11.5 months) in arm B. Treatment was safe and well tolerable in both arms.Conclusions: The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial and numerically favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favored the neoadjuvant arm A [25.5 months (95% CI 19.7-29.7months); arm B 16.7 months (95% CI 11.6-22.2 months)]. There was a d

Background: The prognostic and predictive value of carbohydrate antigen 19-9 (CA 19-9) in locally advanced pancreatic cancer (LAPC) has not yet been defined from prospective randomized controlled trials (RCTs). Patients and methods: A total of 165 LAPC patients were treated within the NEOLAP RCT for 16 weeks with multiagent induction chemotherapy [ICT; either nab-paclitaxel/gemcitabine alone or nab-paclitaxel/gemcitabine followed by FOLFIRINOX (combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin)] followed by surgical exploration of all patients without evidence of disease progression. CA 19-9 was determined at baseline and after ICT and correlated with overall survival (OS) and secondary R0 resection rate. Results: From the NEOLAP study population (N = 165) 133 patients (81%) were evaluable for CA 19-9 at baseline and 81/88 patients (92%) for post-ICT CA 19-9 response. Median OS (mOS) in the CA 19-9 cohort (n = 133) was 16.2 months [95% confidence interval (CI) 13.0-19.4] and R0 resection (n = 31; 23%) was associated with a significant survival benefit [40.8 months (95% CI 21.7-59.8)], while R1 resected patients (n = 14; 11%) had no survival benefit [14.0 (95% CI 11.7-16.3) months, hazard ratio (HR) 0.27; P = 0.001]. After ICT most patients showed a CA 19-9 response (median change from baseline: -82%; relative decrease >= 55%: 83%; absolute decrease to <= 50 U/ml: 43%). Robust CA 19-9 response (decrease to <= 50U/ml) was significantly associated with mOS [27.8 (95% CI 18.4-37.2) versus 16.5 (95% CI 11.7-21.2) months, HR 0.49; P = 0.013], whereas CA 19-9 baseline levels were not prognostic for OS. Multivariate analysis demonstrated that a robust CA 19-9 response was an independent predictive factor for R0 resection. Using a CA 19-9 decrease to <= 61 U/ml as optimal cut-off (by receiver operating characteristic analysis) yielded 72% sensitivity and 62% specificity for successful R0 resection, whereas CA 19-9 nonresponders (<20% decrease or increase)

Background: First-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) includes nab-paclitaxel/gemcitabine. Ibrutinib, a Bruton's tyrosine kinase inhibitor, exhibits antitumor activity through tumor microenvironment modulation. The safety and efficacy of first-line ibrutinib plus nab-paclitaxel/gemcitabine treatment in patients with PDAC were evaluated. Patients and methods: RESOLVE (NCT02436668) was a phase III, randomized, double-blind, placebo-controlled study. Patients (histologically-confirmed PDAC; stage IV diagnosis >6 weeks of randomization; Karnofsky performance score >70) were randomized to once-daily oral ibrutinib (560 mg) or placebo plus nab-paclitaxel (125 mg/m(2)) and gemcitabine (1000 mg/m(2)). Primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate and safety were assessed. Results: In total, 424 patients were randomized (ibrutinib arm, n = 211; placebo arm, n = 213). Baseline characteristics were balanced across arms. After a median follow-up of 25 months, there was no significant difference in OS between ibrutinib plus nab-paclitaxel/gemcitabine versus placebo plus nab-paclitaxel/gemcitabine (median of 9.7 versus 10.8 months; P = 0.3225). PFS was shorter for ibrutinib plus nab-paclitaxel/gemcitabine compared with placebo plus nab-paclitaxel/gemcitabine (median 5.3 versus 6.0 months; P < 0.0001). Overall response rates were 29% and 42%, respectively (P = 0.0058). Patients in the ibrutinib arm had less time on treatment and received lower cumulative doses for all agents compared with the placebo arm. The most common grade >3 adverse events for ibrutinib versus placebo arms included neutropenia (24% versus 35%), peripheral sensory neuropathy (17% versus 8%), and anemia (16% versus 17%). Primary reasons for any treatment discontinuation were disease progression and adverse events. Conclusions: Ibrutinib plus nab-paclitaxel/gemcitabine did not improve OS or PFS for pa

Background: Targeting the epidermal growth factor receptor pathway remains controversial in pancreatic cancer. Afatinib is an oral irreversible ErbB family blocker approved in non-small-cell lung cancer. This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic pancreatic cancer. Patients and methods: Patients were randomised in a 2:1 ratio to either Gem (1000 mg/m(2) weekly for three weeks followed by one week of rest, repeated every four weeks) and afatinib (40 mg orally once daily) or Gem alone. Overall survival (OS) was the primary study endpoint. The novel BOTh(C)(TM) methodology was implemented to derive a quantitative estimate for the 'Burden of Therapy/Toxicity' (BOTh) for each patient on every day during the clinical study. Conclusion: The addition of afatinib to Gem did not improve treatment efficacy and was more toxic. The BOTh(C)(TM) methodology allowed a detailed insight into the course of treatment-related adverse events over the study period. (C) 2021 Elsevier Ltd. All rights reserved.

Background: First-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) includes nab-paclitaxel/gemcitabine. Ibrutinib, a Bruton's tyrosine kinase inhibitor, exhibits antitumor activity through tumor microenvironment modulation. The safety and efficacy of first-line ibrutinib plus nab-paclitaxel/gemcitabine treatment in patients with PDAC were evaluated. Patients and methods: RESOLVE (NCT02436668) was a phase III, randomized, double-blind, placebo-controlled study. Patients (histologically-confirmed PDAC; stage IV diagnosis >6 weeks of randomization; Karnofsky performance score >70) were randomized to once-daily oral ibrutinib (560 mg) or placebo plus nab-paclitaxel (125 mg/m(2)) and gemcitabine (1000 mg/m(2)). Primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate and safety were assessed. Results: In total, 424 patients were randomized (ibrutinib arm, n = 211; placebo arm, n = 213). Baseline characteristics were balanced across arms. After a median follow-up of 25 months, there was no significant difference in OS between ibrutinib plus nab-paclitaxel/gemcitabine versus placebo plus nab-paclitaxel/gemcitabine (median of 9.7 versus 10.8 months; P = 0.3225). PFS was shorter for ibrutinib plus nab-paclitaxel/gemcitabine compared with placebo plus nab-paclitaxel/gemcitabine (median 5.3 versus 6.0 months; P < 0.0001). Overall response rates were 29% and 42%, respectively (P = 0.0058). Patients in the ibrutinib arm had less time on treatment and received lower cumulative doses for all agents compared with the placebo arm. The most common grade >3 adverse events for ibrutinib versus placebo arms included neutropenia (24% versus 35%), peripheral sensory neuropathy (17% versus 8%), and anemia (16% versus 17%). Primary reasons for any treatment discontinuation were disease progression and adverse events. Conclusions: Ibrutinib plus nab-paclitaxel/gemcitabine did not improve OS or PFS for pa

Background: Targeting the epidermal growth factor receptor pathway remains controversial in pancreatic cancer. Afatinib is an oral irreversible ErbB family blocker approved in non-small-cell lung cancer. This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic pancreatic cancer. Patients and methods: Patients were randomised in a 2:1 ratio to either Gem (1000 mg/m(2) weekly for three weeks followed by one week of rest, repeated every four weeks) and afatinib (40 mg orally once daily) or Gem alone. Overall survival (OS) was the primary study endpoint. The novel BOTh(C)(TM) methodology was implemented to derive a quantitative estimate for the 'Burden of Therapy/Toxicity' (BOTh) for each patient on every day during the clinical study. Conclusion: The addition of afatinib to Gem did not improve treatment efficacy and was more toxic. The BOTh(C)(TM) methodology allowed a detailed insight into the course of treatment-related adverse events over the study period. (C) 2021 Elsevier Ltd. All rights reserved.

Background: CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles. Patients and methods: This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment. Results: 122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021). Conclusion: CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients. (C) 2020 Published by Elsevier Ltd.

Background: CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles. Patients and methods: This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment. Results: 122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021). Conclusion: CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients. (C) 2020 Published by Elsevier Ltd.

Background: Adenocarcinomas or combined adeno-neuroendocrine carcinomas (MANEC) of small bowel usually have a dismal prognosis with limited systemic therapy options. This is the first description of a patient showing a germline-related BRCA1 mutated MANEC of his ileum. The tumor presented a susceptibility to a combined chemotherapy and the PARP1-inhibitor olaparib. Case presentation: A 74-year old male patient presented with a metastasized MANEC of his ileum. Due to clinical symptoms his ileum-tumor and the single brain metastasis were removed. We verified the same pathogenic (class 5) BRCA1 mutation in different tumor locations. There was no known personal history of a previous malignant tumor. Nevertheless we identified his BRCA1 mutation as germline-related. A systemic treatment was started including Gemcitabine followed by selective internal radiotherapy (SIRT) to treat liver metastases and in the further course Capecitabine but this treatment finally failed after 9 months and all liver metastases showed progression. The treatment failure was the reason to induce an individualized therapeutic approach using combined chemotherapy of carboplatin, paclitaxel and the Poly (ADP-ribose) polymerase-(PARP)-inhibitor olaparib analogous to the treatment protocol of Oza et al. All liver metastases demonstrated with significant tumor regression after 3 months and could be removed. In his most current follow up from December 2017 (25 months after his primary diagnosis) the patient is in a very good general condition without evidence for further metastases. Conclusion: We present first evidence of a therapy susceptible germline-related BRCA1 mutation in small bowel adeno-neuroendocrine carcinoma (MANEC). Our findings offer a personalized treatment option. The germline background was unexpected in a 74-year old man with no previously known tumor burden. We should be aware of the familiar background in tumors of older patients as well.

Background: Adenocarcinomas or combined adeno-neuroendocrine carcinomas (MANEC) of small bowel usually have a dismal prognosis with limited systemic therapy options. This is the first description of a patient showing a germline-related BRCA1 mutated MANEC of his ileum. The tumor presented a susceptibility to a combined chemotherapy and the PARP1-inhibitor olaparib. Case presentation: A 74-year old male patient presented with a metastasized MANEC of his ileum. Due to clinical symptoms his ileum-tumor and the single brain metastasis were removed. We verified the same pathogenic (class 5) BRCA1 mutation in different tumor locations. There was no known personal history of a previous malignant tumor. Nevertheless we identified his BRCA1 mutation as germline-related. A systemic treatment was started including Gemcitabine followed by selective internal radiotherapy (SIRT) to treat liver metastases and in the further course Capecitabine but this treatment finally failed after 9 months and all liver metastases showed progression. The treatment failure was the reason to induce an individualized therapeutic approach using combined chemotherapy of carboplatin, paclitaxel and the Poly (ADP-ribose) polymerase-(PARP)-inhibitor olaparib analogous to the treatment protocol of Oza et al. All liver metastases demonstrated with significant tumor regression after 3 months and could be removed. In his most current follow up from December 2017 (25 months after his primary diagnosis) the patient is in a very good general condition without evidence for further metastases. Conclusion: We present first evidence of a therapy susceptible germline-related BRCA1 mutation in small bowel adeno-neuroendocrine carcinoma (MANEC). Our findings offer a personalized treatment option. The germline background was unexpected in a 74-year old man with no previously known tumor burden. We should be aware of the familiar background in tumors of older patients as well.

We studied a cohort of adult patients with chronic hepatitis B (CHB) infection, followed at a tertiary referral liver center in Germany over 12.5 years to analyze the clinical features and impact of management on disease progression and survival of CHB patients in general and of those with CHB and HCC in particular. We retrospectively evaluated the medical records of 242 adult (age a parts per thousand yen 18 years) patients. CHB was defined as positive hepatitis B surface antigen (HBsAg) and/or HBV-DNA levels > 10 IU/mL for at least 6 months. Patient demographics, HBV markers, antiviral treatment, laboratory parameters, liver imaging and histology were recorded for each visit. HCC patients were divided into two groups and separately analyzed (group 1: n = 24, HCC at first visit and group 2: n = 11, HCC during surveillance). The mean age was 44 years in CHB patients without HCC (63 % male) and about 59 years in patients with HCC (77 % male). Antiviral therapy was given to 59 % of patients without HCC compared to only 25 % in group 1 and 18 % in group 2 with comparable median HBV DNA levels of approximately 36,000 IU/mL. There was no statistically significant difference concerning the HCC stages (Milan, UCSF, BCLC) at first diagnosis. Five-year survival was 19 % in group 1 vs. 64 % in group 2 (p = 0.019), with LTx performed in 12 vs. 45 %, respectively. Surveillance of CHB patients did not result in early stage detection of HCC but in a higher likelihood to receive potentially curative treatments.

We studied a cohort of adult patients with chronic hepatitis B (CHB) infection, followed at a tertiary referral liver center in Germany over 12.5 years to analyze the clinical features and impact of management on disease progression and survival of CHB patients in general and of those with CHB and HCC in particular. We retrospectively evaluated the medical records of 242 adult (age a parts per thousand yen 18 years) patients. CHB was defined as positive hepatitis B surface antigen (HBsAg) and/or HBV-DNA levels > 10 IU/mL for at least 6 months. Patient demographics, HBV markers, antiviral treatment, laboratory parameters, liver imaging and histology were recorded for each visit. HCC patients were divided into two groups and separately analyzed (group 1: n = 24, HCC at first visit and group 2: n = 11, HCC during surveillance). The mean age was 44 years in CHB patients without HCC (63 % male) and about 59 years in patients with HCC (77 % male). Antiviral therapy was given to 59 % of patients without HCC compared to only 25 % in group 1 and 18 % in group 2 with comparable median HBV DNA levels of approximately 36,000 IU/mL. There was no statistically significant difference concerning the HCC stages (Milan, UCSF, BCLC) at first diagnosis. Five-year survival was 19 % in group 1 vs. 64 % in group 2 (p = 0.019), with LTx performed in 12 vs. 45 %, respectively. Surveillance of CHB patients did not result in early stage detection of HCC but in a higher likelihood to receive potentially curative treatments.

Background: Patients with ileostomies regularly suffer from short bowel syndrome or high volume output associated with loss of absorptive surface and subsequent impairment of absorption for drugs and different nutrients resulting in electrolyte and fluid balance disorders as well as renal insufficiency. Adaptation of these fundamental functions of the gut with adequate fluid uptake, absorption of sufficient different nutrients and vitamins represents a major challenge to rehabilitate these patients shortly after surgery. Patients with ileostomy often develop metabolic acidosis with normal anion gap. In our retrospective study we would like to draw attention to these metabolic disorders in patients with ileostomy in comparison to patients with colostomy and patients undergoing gastrectomy for gastric cancer. Methods: In the period from 2005 to 2012 we examined 164 patients with ileostomy in our rehabilitation clinic, 109 patients with colostomy and 193 patients after surgery for gastric cancer of the possible presence of metabolic acidosis by using capillary blood gas analysis (metabolic acidosis was anticipated, if base excess was <= -3,0 mmol/l). Patients are treated as inpatients both in early stage and for follow-up rehabilitation. The length of time in our rehabilitation clinic lies inbetween 24-28 days. On the basis of random samples we tested blood samples in 19 patients with ileostomy in succession for ferritin, folic acid, zinc, selenium and vitamin B12. Statistical analysis comprised the classical intervals (mean and standard deviation, range and T-test for dependent and indipendent samples). Results: In total we tested 164 inpatients with ileostomy in our rehabilitation clinic (median age 67.4 years, range 19-79 years). The time for surgery for ileostomy took place about 1.4 months on average ago (range 1/4-56 months). 60 (36.5 %) inpatients suffered from metabolic acidosis often combined with renal insufficiency. Supportive therapy intravenously administe

Background: Patients with ileostomies regularly suffer from short bowel syndrome or high volume output associated with loss of absorptive surface and subsequent impairment of absorption for drugs and different nutrients resulting in electrolyte and fluid balance disorders as well as renal insufficiency. Adaptation of these fundamental functions of the gut with adequate fluid uptake, absorption of sufficient different nutrients and vitamins represents a major challenge to rehabilitate these patients shortly after surgery. Patients with ileostomy often develop metabolic acidosis with normal anion gap. In our retrospective study we would like to draw attention to these metabolic disorders in patients with ileostomy in comparison to patients with colostomy and patients undergoing gastrectomy for gastric cancer. Methods: In the period from 2005 to 2012 we examined 164 patients with ileostomy in our rehabilitation clinic, 109 patients with colostomy and 193 patients after surgery for gastric cancer of the possible presence of metabolic acidosis by using capillary blood gas analysis (metabolic acidosis was anticipated, if base excess was <= -3,0 mmol/l). Patients are treated as inpatients both in early stage and for follow-up rehabilitation. The length of time in our rehabilitation clinic lies inbetween 24-28 days. On the basis of random samples we tested blood samples in 19 patients with ileostomy in succession for ferritin, folic acid, zinc, selenium and vitamin B12. Statistical analysis comprised the classical intervals (mean and standard deviation, range and T-test for dependent and indipendent samples). Results: In total we tested 164 inpatients with ileostomy in our rehabilitation clinic (median age 67.4 years, range 19-79 years). The time for surgery for ileostomy took place about 1.4 months on average ago (range 1/4-56 months). 60 (36.5 %) inpatients suffered from metabolic acidosis often combined with renal insufficiency. Supportive therapy intravenously administe

We studied a cohort of adult patients with chronic hepatitis B (CHB) infection, followed at a tertiary referral liver center in Germany over 12.5 years to analyze the clinical features and impact of management on disease progression and survival of CHB patients in general and of those with CHB and HCC in particular. We retrospectively evaluated the medical records of 242 adult (age a parts per thousand yen 18 years) patients. CHB was defined as positive hepatitis B surface antigen (HBsAg) and/or HBV-DNA levels > 10 IU/mL for at least 6 months. Patient demographics, HBV markers, antiviral treatment, laboratory parameters, liver imaging and histology were recorded for each visit. HCC patients were divided into two groups and separately analyzed (group 1: n = 24, HCC at first visit and group 2: n = 11, HCC during surveillance). The mean age was 44 years in CHB patients without HCC (63 % male) and about 59 years in patients with HCC (77 % male). Antiviral therapy was given to 59 % of patients without HCC compared to only 25 % in group 1 and 18 % in group 2 with comparable median HBV DNA levels of approximately 36,000 IU/mL. There was no statistically significant difference concerning the HCC stages (Milan, UCSF, BCLC) at first diagnosis. Five-year survival was 19 % in group 1 vs. 64 % in group 2 (p = 0.019), with LTx performed in 12 vs. 45 %, respectively. Surveillance of CHB patients did not result in early stage detection of HCC but in a higher likelihood to receive potentially curative treatments.

Background: Patients with ileostomies regularly suffer from short bowel syndrome or high volume output associated with loss of absorptive surface and subsequent impairment of absorption for drugs and different nutrients resulting in electrolyte and fluid balance disorders as well as renal insufficiency. Adaptation of these fundamental functions of the gut with adequate fluid uptake, absorption of sufficient different nutrients and vitamins represents a major challenge to rehabilitate these patients shortly after surgery. Patients with ileostomy often develop metabolic acidosis with normal anion gap. In our retrospective study we would like to draw attention to these metabolic disorders in patients with ileostomy in comparison to patients with colostomy and patients undergoing gastrectomy for gastric cancer. Methods: In the period from 2005 to 2012 we examined 164 patients with ileostomy in our rehabilitation clinic, 109 patients with colostomy and 193 patients after surgery for gastric cancer of the possible presence of metabolic acidosis by using capillary blood gas analysis (metabolic acidosis was anticipated, if base excess was <= -3,0 mmol/l). Patients are treated as inpatients both in early stage and for follow-up rehabilitation. The length of time in our rehabilitation clinic lies inbetween 24-28 days. On the basis of random samples we tested blood samples in 19 patients with ileostomy in succession for ferritin, folic acid, zinc, selenium and vitamin B12. Statistical analysis comprised the classical intervals (mean and standard deviation, range and T-test for dependent and indipendent samples). Results: In total we tested 164 inpatients with ileostomy in our rehabilitation clinic (median age 67.4 years, range 19-79 years). The time for surgery for ileostomy took place about 1.4 months on average ago (range 1/4-56 months). 60 (36.5 %) inpatients suffered from metabolic acidosis often combined with renal insufficiency. Supportive therapy intravenously administe

We studied a cohort of adult patients with chronic hepatitis B (CHB) infection, followed at a tertiary referral liver center in Germany over 12.5 years to analyze the clinical features and impact of management on disease progression and survival of CHB patients in general and of those with CHB and HCC in particular. We retrospectively evaluated the medical records of 242 adult (age a parts per thousand yen 18 years) patients. CHB was defined as positive hepatitis B surface antigen (HBsAg) and/or HBV-DNA levels > 10 IU/mL for at least 6 months. Patient demographics, HBV markers, antiviral treatment, laboratory parameters, liver imaging and histology were recorded for each visit. HCC patients were divided into two groups and separately analyzed (group 1: n = 24, HCC at first visit and group 2: n = 11, HCC during surveillance). The mean age was 44 years in CHB patients without HCC (63 % male) and about 59 years in patients with HCC (77 % male). Antiviral therapy was given to 59 % of patients without HCC compared to only 25 % in group 1 and 18 % in group 2 with comparable median HBV DNA levels of approximately 36,000 IU/mL. There was no statistically significant difference concerning the HCC stages (Milan, UCSF, BCLC) at first diagnosis. Five-year survival was 19 % in group 1 vs. 64 % in group 2 (p = 0.019), with LTx performed in 12 vs. 45 %, respectively. Surveillance of CHB patients did not result in early stage detection of HCC but in a higher likelihood to receive potentially curative treatments.

We studied a cohort of adult patients with chronic hepatitis B (CHB) infection, followed at a tertiary referral liver center in Germany over 12.5 years to analyze the clinical features and impact of management on disease progression and survival of CHB patients in general and of those with CHB and HCC in particular. We retrospectively evaluated the medical records of 242 adult (age a parts per thousand yen 18 years) patients. CHB was defined as positive hepatitis B surface antigen (HBsAg) and/or HBV-DNA levels > 10 IU/mL for at least 6 months. Patient demographics, HBV markers, antiviral treatment, laboratory parameters, liver imaging and histology were recorded for each visit. HCC patients were divided into two groups and separately analyzed (group 1: n = 24, HCC at first visit and group 2: n = 11, HCC during surveillance). The mean age was 44 years in CHB patients without HCC (63 % male) and about 59 years in patients with HCC (77 % male). Antiviral therapy was given to 59 % of patients without HCC compared to only 25 % in group 1 and 18 % in group 2 with comparable median HBV DNA levels of approximately 36,000 IU/mL. There was no statistically significant difference concerning the HCC stages (Milan, UCSF, BCLC) at first diagnosis. Five-year survival was 19 % in group 1 vs. 64 % in group 2 (p = 0.019), with LTx performed in 12 vs. 45 %, respectively. Surveillance of CHB patients did not result in early stage detection of HCC but in a higher likelihood to receive potentially curative treatments.

Background: Patients with ileostomies regularly suffer from short bowel syndrome or high volume output associated with loss of absorptive surface and subsequent impairment of absorption for drugs and different nutrients resulting in electrolyte and fluid balance disorders as well as renal insufficiency. Adaptation of these fundamental functions of the gut with adequate fluid uptake, absorption of sufficient different nutrients and vitamins represents a major challenge to rehabilitate these patients shortly after surgery. Patients with ileostomy often develop metabolic acidosis with normal anion gap. In our retrospective study we would like to draw attention to these metabolic disorders in patients with ileostomy in comparison to patients with colostomy and patients undergoing gastrectomy for gastric cancer. Methods: In the period from 2005 to 2012 we examined 164 patients with ileostomy in our rehabilitation clinic, 109 patients with colostomy and 193 patients after surgery for gastric cancer of the possible presence of metabolic acidosis by using capillary blood gas analysis (metabolic acidosis was anticipated, if base excess was <= -3,0 mmol/l). Patients are treated as inpatients both in early stage and for follow-up rehabilitation. The length of time in our rehabilitation clinic lies inbetween 24-28 days. On the basis of random samples we tested blood samples in 19 patients with ileostomy in succession for ferritin, folic acid, zinc, selenium and vitamin B12. Statistical analysis comprised the classical intervals (mean and standard deviation, range and T-test for dependent and indipendent samples). Results: In total we tested 164 inpatients with ileostomy in our rehabilitation clinic (median age 67.4 years, range 19-79 years). The time for surgery for ileostomy took place about 1.4 months on average ago (range 1/4-56 months). 60 (36.5 %) inpatients suffered from metabolic acidosis often combined with renal insufficiency. Supportive therapy intravenously administe