Evaluation of the efficacy of octreotide LAR in the treatment of Crohn's disease associated refractory diarrhea.

OBJECTIVES: Diarrhea is one of the main symptoms of Crohn's disease (CD). It is usually significantly improved with specific CD treatments, loperamide or cholestyramine. However, in some cases, diarrhea becomes refractory. The aim of this study was to assess the safety and efficacy of octreotide in this situation. MATERIALS AND METHODS: Fifteen patients with CD refractory diarrhea defined by at least an average of five smooth or liquid stools per day despite an optimized CD treatment were included from three Belgian centers. Two patients were lost to follow-up. A subcutaneous injection of 100 µg octreotide was performed three times a day during three days. When the drug had been well tolerated, an intramuscular injection of 30 mg octreotide (Sandostatin® LAR 30) was realized. Evaluation was done at day 31. The primary endpoint was to assess the effect on the mean number of smooth or liquid stools per day. RESULTS: A significant reduction (p = 0.0001) of the average number of smooth or liquid stools over the last seven days was observed between baseline and day 31. The maximum number of smooth or liquid stools also significantly decreased (p = 0.0009). Four patients (26.7%) presented mild nonspecific adverse events but no serious one. We also observed a significant decrease (p = 0.0006) of the Harvey-Bradshaw Index (HBI) and a significant improvement (p = 0.0012) of the inflammatory bowel disease questionnaire (IBDQ). CONCLUSIONS: In this uncontrolled open-label study, octreotide appeared safe and effective in CD refractory diarrhea, in addition to CD treatments. It significantly improved the number of liquid or smooth stools, the HBI and the IBDQ.

Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids.

BACKGROUND & AIMS: Severe alcoholic hepatitis (AH) is a life-threatening disease for which adequate oral nutritional support is recommended. We performed a randomized controlled trial to determine whether the combination of corticosteroid and intensive enteral nutrition therapy is more effective than corticosteroid therapy alone in patients with severe AH. METHODS: We enrolled 136 heavy consumers of alcohol (age, 18-75 y) with recent onset of jaundice and biopsy-proven severe AH in our study, performed at 18 hospitals in Belgium and 2 in France, from February 2010 through February 2013. Subjects were assigned randomly (1:1) to groups that received either intensive enteral nutrition plus methylprednisolone or conventional nutrition plus methylprednisolone (controls). In the intensive enteral nutrition group, enteral nutrition was given via feeding tube for 14 days. The primary end point was patient survival for 6 months. RESULTS: In an intention-to-treat analysis, we found no significant difference between groups in 6-month cumulative mortality: 44.4% of patients died in the intensive enteral nutrition group (95% confidence interval [CI], 32.2%-55.9%) and 52.1% of controls died (95% CI, 39.4%-63.4%) (P = .406). The enteral feeding tube was withdrawn prematurely from 48.5% of patients, and serious adverse events considered to be related to enteral nutrition occurred in 5 patients. Regardless of group, a greater proportion of patients with a daily calorie intake less than 21.5 kcal/kg/day died (65.8%; 95% CI, 48.8-78.4) than patients with a higher intake of calories (33.1%; 95% CI, 23.1%-43.4%) (P < .001). CONCLUSIONS: In a randomized trial of patients with severe AH treated with corticosteroids, we found that intensive enteral nutrition was difficult to implement and did not increase survival. However, low daily energy intake was associated with greater mortality, so adequate nutritional intake should be a main goal for treatment. ClinicalTrials.gov number: NCT01801332.

Endoscopic findings in case of incidental colonic uptake in PET-CT how to improve PET-CT specificity?

Unexpected colonic 18FDG focal uptakes (UCFU) in PET CT occur in 1.3-3.3% of cases in retrospective study and are often associated with significant colorectal findings in endoscopy, especially neoplastic lesions. The purpose of our prospective study was to evaluate the significance of UCFU and to assess criteria improving PET CT specificity for advanced adenoma and neoplasia. This study was conducted in a single institution from April 2012 to September 2013. In the 2904 patients who benefit from PET CT, 52 had an UCFU and 43 were referred for colonoscopy. After endoscopy, 8 examinations showed no colonic abnormality (18.6%), 7 showed benign lesion (16.3%), 18 showed advanced adenoma (42.9%) and 10 showed carcinoma (23.3%). There were more false positives results in the proximal colon compared to distal colon. Eighteen patients had UCFU and tomodensitometric abnormalities in the same colonic area. This pathological combination was strongly associated to the diagnosis of malignancy. Comparing standardized uptake values (SUV), we showed statistically significant difference between the adenocarcinoma and advanced adenoma groups and a difference at the margin of statistical significance between adenocarcinoma and benign lesion groups. Any cut off value could be determined. In conclusion, we confirmed that UCFU are often associated to endoscopic findings and neoplastic lesions and justify systematic endoscopic exploration. Considering the fragility of oncologic patients, criteria improving PET CT specificity are needed to select endoscopies which should be performed quickly from those who could be delayed. We showed that associated tomodensitometric abnormality and high focal FDG activity are more predictive of a neoplastic lesion.

Three-year results of a multicenter prospective study of transoral incisionless fundoplication.

BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. RESULTS: Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. CONCLUSIONS: The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.

BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.

HCV genotype 4 in Belgium: three distinct patterns among patients from European and African origin.

BACKGROUND: Considered uncommon in western countries some years ago, hepatitis C virus of genotype 4 is now spreading in some areas of Europe. This is assumed to be due to immigration from a region of high prevalence for this genotype and to propagation among drug users. In the south of Belgium, genotype 4 currently accounts for 10% of hepatitis C virus patients and its prevalence is increasing with time. OBJECTIVE: To better define the genotype 4 carriers' characteristics. METHODS: In a database comprising 1726 viraemic hepatitis C virus patients, the files of 85 genotype 4 carriers were reviewed. RESULTS: Beside the African (58%) and European drug user (15%) subgroups classically described, a third subgroup consisting of European nondrug users (26%) was identified as peculiar: these patients were older, had been mostly contaminated sporadically, presented a great diversity of subtypes, and were mainly of Italian origin. In this subgroup, contamination was supposed to be ancient, having occurred probably in Italy before immigration into Belgium. By contrast, European drug users were infected with only two subtypes (4c/4d and 4), an observation in favour of recent spread. Africans had a great diversity of subtypes, were young, and were mostly contaminated sporadically in their home countries. Despite their epidemiological differences, the clinical management, and in particular the rates of eligibility for treatment, were similar for these three groups. CONCLUSIONS: Three different patterns of genotype 4 carriers were observed, corresponding to three different spreading profiles. They did not induce, however, different clinical management.

Evolution over a 10 year period of the epidemiological profile of 1,726 newly diagnosed HCV patients in Belgium.

In order to evaluate the future burden of hepatitis C, there is a need to quantify the evolution with time of some crucial parameters such as disease frequency and age, modes of infection and infecting genotypes of patients presenting for the first time at consultation. The yearly evolution of these parameters was analyzed retrospectively in a cohort of 1,726 patients living in Belgium, who were diagnosed as hepatitis C virus (HCV) carriers by polymerase chain reaction (PCR) between 1992 and 2002. The epidemiological profile of HCV patients showed significant changes during this period. The number of new patients increased with time. The proportion of patients under 50 increased linearly at a rate of 3% per year. The rate of newly presenting patients infected by transfusion before 1990 decreased, but only by 2.7% per year. The proportion of intravenous (IV) drug users increased by 2.5% per year. Patients presenting "undefined" risk factors increased by 2.1% per year. Nosocomial acquisition of HCV infection exhibited a disturbing relative stability in time whereas dialysis tended to disappear as a cause of infection. There was a significant linear annual decrease of 2.3% in the frequency of genotype 1b, which was counterbalanced by a significant increase of 0.7% for genotype 1a and 1.1% for genotype 4. Genotypes 2 and 3 did not vary significantly with time. Such figures are useful for evaluating the epidemiological changes of C virus infection and for anticipating the future economical cost of hepatitis C treatment in the next few years.

Hepatitis C virus genotype 5 in southern belgium: epidemiological characteristics and response to therapy.

Data are scarce on patients infected with hepatitis C virus of genotype 5, due to the low prevalence of this genotype around the world. To better define the characteristics of these patients, we reviewed the files of 16 genotype 5 patients. Mean age was 38 +/- 14. All patients were of European origin. Most of them (75%) had been contaminated by transfusion within a short time period (between 1980 and 1991). There were no intravenous drug addicts. Seven patients received treatment. One patient did not respond to interferon (IFN) monotherapy. Of four patients treated with IFN and ribavirin, three became sustained viral responders. Two patients treated with pegylated IFN and ribavirin became sustained viral responders. In our region, genotype 5 patients seem to have been contaminated within a relatively short time period. Treatment with IFN or pegylated IFN and ribavirin gave a high rate (83%) of sustained viral responses.