[Bowel resections for Crohn's disease: developments over the last three decades]. / Drei Dekaden Darmresektionen bei Patienten mit M. Crohn.

BACKGROUND: The present observational study demonstrates developments of surgery in Crohn's disease patients undergoing bowel resection at two tertiary referral centers during the recent 3 decades. METHODS: Consecutive patients undergoing intestinal resections were included. Exclusion criteria were: resection for malignancy, mere stoma formation and closure, bowel resections for other reasons than Crohn's disease, abdomino-perineal resections for anal fistula. Data collection was retrospective between 1992 and 2004, and prospective thereafter. Six time periods were compared: 1992-1995, 1996-2000, 2001-2005, 2006-2010, 2011-2015, and 2016-2020. RESULTS: Between 2000 and 2015 several significant developments could be observed: decline in preoperative steroid intake, increase in preoperative intake of immunomodulators and biologic agents; abandonment of preoperative mechanical bowel preparation, increase in surgery for penetrating disease and more patients with previous bowel resections, increase in laparoscopy use, stoma rate and postoperative morbidity. Since 2016, mechanical bowel preparation and oral antibiotics were (re)introduced, there was significantly more laparoscopic surgery (67%), preoperative steroid and immunomodulator intake diminished, whereas preoperative biological therapy increased; patients were older and less were active smokers; stoma formation rate and morbidity rate decreased significantly. CONCLUSION: There were several very strong trends in Crohn's disease surgery during the last 3 decades. However, present results cannot be generalized to broader patient' population.

Longitudinal evaluation of efficacy, safety and nutritional status during one-year treatment with the duodenal-jejunal bypass liner.

BACKGROUND: The endoscopic duodenal-jejunal bypass liner (DJBL) represents a novel temporary endoscopic approach for treatment of obesity-associated type 2 diabetes. Recent results from the German DJBL registry confirmed substantial positive metabolic effects of the DJBL in type 2 diabetes. However, the last Food and Drug Administration trial was stopped due to a high occurrence of hepatic abscesses (3.5%). OBJECTIVES: Here, we analyzed time courses of development of co-morbidities, nutritive changes, and occurrence of adverse events during the 1-year treatment phase with the DJBL in the German DJBL registry. METHODS: Sixty-six patients from the registry were analyzed for efficacy, safety, and nutritional status. Patient data sets were analyzed at implantation, 3 and 6 months after implantation, and at explantation visits. RESULTS: Weight, body mass index, glycated hemoglobin, and low-density lipoprotein cholesterol primarily declined during the first 3 months after implantation, whereas systolic and diastolic blood pressure were predominantly reduced during the second half of the treatment phase. Severe DJBL-associated side effects were mainly documented at the explantation visit (intestinal obstruction [1.7%], dislocation [1.7%], and liver abscess [1.7%]). Measurements of serum concentrations of ferritin, albumin, vitamin B12, folic acid, 25-hydroxyvitamin D3 (25 OH-Vit-D3), and calcium provided suggestive evidence of a possible decrease of nutritional absorption of vitamins and trace elements by the DJBL. CONCLUSIONS: The DJBL demonstrates high efficacy with substantial improvement of all parameters of the metabolic syndrome and the potential for reduction of comedications in overweight patients with type 2 diabetes. These registry results are important to optimize recommendations for adaptation of concomitant medication, surveillance of adverse events, nutritional status and supplementation, and adaptation of the implantation period of the DJBL.

Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL).

BACKGROUND: A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obese patients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report. METHODS: Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32). RESULTS: For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m2 (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher). CONCLUSION: With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obese patients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02731859.

Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study.

AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS: To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS: Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION: This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.

Genital Granulomatosis in Male and Female Patients With Crohn's Disease: Clinical Presentation and Treatment Outcomes.

BACKGROUND: Genital granulomatosis [GG] is a metastatic form of Crohn's disease [CD], characterised by granulomatous inflammation of the genital skin without contact with the gastrointestinal tract. Little is known about GG, as most publications are case reports or small series, and only sporadic in male cases. METHODS AND AIMS: Cases of GG were retrospectively collected through the Collaborative Network For Exceptionally Rare case reports project of the European Crohn's and Colitis Organisation. RESULTS: A total of 43 patients [9 males, 34 females] were diagnosed as having GG, mostly as oedema and/or ulcers. Histological confirmation of granulomas was obtained in 70% of the cases. CD location was colonic or ileocolonic in 97% and perianal disease was documented in 57%. There was no significant difference between males and females in CD phenotype or genital lesions. GG was the first manifestation of inflammatory bowel disease [IBD] in one-third of the patients; these patients were younger at the time of GG occurrence and they all were non-smokers. GG occurred in the absence of gastrointestinal disease activity in 30% of the cases. Ten out of 11 patients [91%] responded to systemic corticosteroid treatment, 5/9 patients responded to immunomodulators, and 9/11 patients responded to anti-tumour necrosis factor alpha [TNF-α] agents. CONCLUSIONS: GG is a rare extraintestinal manifestation of CD. It mainly occurs among women, in the setting of colonic involvement of CD, and perianal disease is often associated. Most cases are successfully managed with systemic corticosteroids or anti-TNF agents.

Hyperoxia-induced improvement of the in vitro response to gemcitabine in transitional cell carcinoma.

BACKGROUND: Anemic tissue hypoxia can decrease the effects of chemotherapy in bladder cancer. Hypoxia leads to overexpression of hypoxia-inducible factor (HIF) and increased synthesis of epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF). Tumor cell survival, invasion and angiogenesis thereby compromise treatment. MATERIALS AND METHODS: Monolayer cultures of RT112, RT4, T24 and TCC SUP cells were incubated with or without gemcitabine and different gas mixtures (hypoxia, normoxia or hyperoxia). Cell proliferation (microculture tetrazolium assay), VEGF (enzyme-linked immunosorbent assay) and HIF-1alpha (Western blot analysis) were determined. RESULTS: Hypoxia led to increased proliferation of transitional cell carcinoma (TCC) cells and elevated levels of HIF-1alpha and VEGF. Hyperoxia inhibited cell growth and lowered the concentration of VEGF. Treatment with gemcitabine was less effective under hypoxia. CONCLUSION: Hypoxia enhances TCC growth and may intensify angiogenesis mediated by VEGF. Hypoxia compromises treatment with gemcitabine. Correction of anemia might provide advantages in chemotherapeutic strategies for TCC.