Prospective multicenter evaluation of colon capsule examination indicated by colonoscopy failure or anesthesia contraindication.

BACKGROUND AND STUDY AIMS: In France, in about 5% of cases colonoscopies are incomplete or temporarily contraindicated.We tested the diagnostic yield of colon capsule endoscopy (CCE) in these patients. PATIENTS AND METHODS: In a prospective study, in 17 French centers, inclusion criteria were colonoscopy failure or general disease that excluded colonoscopy with anesthesia. Patients underwent CCE using the first-generation PillCam Colon capsule. The main end point was CCE diagnostic yield, defined as identification of a colorectal lesion that directly explained symptoms or necessitated a diagnostic or therapeutic examination. A secondary objective was to test a simplified Movi-Prep colon cleansing. Follow-up to identify missed symptomatic cancer was scheduled. RESULTS: CCE showed positive findings in 36 patients (diagnostic yield 33.6 %), among whom 23 subsequently underwent therapeutic intervention. Among 64 patients with negative capsule findings, 9 had a complementary procedure showing adenomas in only 1 case. CCE was incomplete in 7/107 patients. Colonoscopy was done in one patient to retrieve a capsule retained in the left colon, and sigmoidoscopy in 11 because the rectum was not reached. No colorectal cancer was diagnosed during the follow-up period. Colon cleansing with MoviPrep was rated good or excellent in 75.9% of cases. CONCLUSION: This study shows the feasibility and the usefulness of CCE in the situation of colonoscopy failure or contraindication. The colon capsule modality should be tested against other available approaches, such as virtual colonoscopy or repeat colonoscopy by an expert.

Evolution of HCV incidence in drug users in France.

Over the last 40 years, the dynamics of hepatitis C virus (HCV) infection in drug users has been affected by the illicit drug market, the health environment including the devastating impact of the HIV/AIDS epidemic which erupted in the 1980s, and the diffusion of substitution treatment beginning in 1995. The purpose of this literature review is to present the dynamics of HCV infection in drug users in France over the last 40 years. Two prevalence studies of HCV infection in the general population were conducted by the French Institute for Public Health Surveillance in 1994 and 2004 and were the touchstone data sources for this analysis. Hypotheses constructed from the findings of these two studies were examined in light of results reported by multicentre prevalence and incidence studies in drug-user populations. The incidence of HCV infection in drug users in France reached a peak in the late 1980s or early 1990s after a lengthy period of epidemic expansion. Implementation of a risk reduction policy enabled a very significant reduction in the incidence of HCV infection in drug users over the last 20 years, leading to incidence figures which are now 10-15% of the 1990 estimate.

Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer.

BACKGROUND: Colon capsule endoscopy (CCE) is a new, non-invasive technology. AIM: To conduct a prospective, multicentre trial to compare CCE and colonoscopy in asymptomatic subjects enrolled in screening or surveillance programmes for the detection of colorectal neoplasia. METHODS: Patients underwent CCE on day one and colonoscopy (gold standard) on day two. CCE and colonoscopy were performed by independent endoscopists. RESULTS: A total of 545 patients were recruited. CCE was safe and well-tolerated. Colon cleanliness was excellent or good in 52% of cases at CCE. Five patients with cancer were detected by colonoscopy, of whom two were missed by CCE. CCE accuracy for the detection of polyps ≥ 6 mm was 39% (95% CI 30-48) for sensitivity, 88% (95% CI 85-91) for specificity, 47% (95% CI 37-57) for positive predictive value and 85% (95% CI 82-88) for negative predictive value. CCE accuracy was better for the detection of advanced adenoma, in patients with good or excellent cleanliness and after re-interpretation of the CCE videos by an independent expert panel. CONCLUSIONS: Although well-tolerated, CCE cannot replace colonoscopy as a first line investigation for screening and surveillance of patients at risk of cancer. Further studies should pay attention to colonic preparation (Clinicaltrial.gov number NCT00436514).

Diagnostic accuracy of esophageal capsule endoscopy versus conventional upper digestive endoscopy for suspected esophageal squamous cell carcinoma.

BACKGROUND AND STUDY AIM: A video capsule similar to that used in small-bowel capsule endoscopy is now available for esophageal exploration. The aim of our study was to compare the accuracy of upper endoscopy (esophageal gastroduodenoscopy [EGE]) with esophageal capsule endoscopy (ECE) in patients at risk of esophageal squamous cell cancer (SCC). PATIENTS AND METHODS: 68 patients at risk of SCC secondary to a history of head and neck neoplasia were included in this comparison of techniques for detecting SCC and dysplasia. ECE was done using the first generation Pillcam ESO and EGE was performed in accordance with the usual practice of each center, followed by examination with 2 % Lugol staining and biopsy of unstained areas (39 neoplasia comprising 5 low grade dysplasia, 8 high grade dysplasia and 26 SCC). RESULTS: Compared with EGE with and without Lugol staining, the sensitivities of ECE for neoplasia diagnosis were 46 % and 54 %, respectively. On a per-patient basis, the sensitivity, specificity, and positive and negative predictive value of ECE were 63 %, 86 %, 77 % and 76 %, respectively, compared with EGE without staining, and 61 %, 86 %, 77 % and 73 % compared with EGE with iodine staining. Neither the ECE transit time nor the distance between the esopharyngeal line and the neoplastic lesion differed between the 21 false-negative and 18 true-positive cases diagnosed by ECE; the only difference was a smaller median diameter among false negatives ( P < 0.001). CONCLUSION: In a cohort at high risk for esophageal SCC, ECE is not sensitive enough to diagnose neoplastic lesions.

The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract.

BACKGROUND: Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging. Fluorescent contrast agents are used to optimize imaging with CLE, and intravenous fluorescein is the most widely used contrast agent. Fluorescein is FDA-cleared for diagnostic angiography of the retina. For these indications, the safety profile of fluorescein has been well-documented; however, to date, fluorescein is not cleared for use with CLE. AIMS: To estimate the rate of serious and total adverse events attributable to intravenous fluorescein when used for gastrointestinal CLE. METHODS: We performed a cross sectional survey of 16 International Academic Medical Centres with active research protocols in CLE that involved intravenous fluorescein. Centres using i.v. fluorescein for CLE who were actively monitored for adverse events were included. RESULTS: Sixteen centres performed 2272 gastrointestinal CLE procedures. The most common dose of contrast agent was 2.5-5 mL of 10% sodium fluorescein. No serious adverse events were reported. Mild adverse events occurred in 1.4% of individuals, including nausea/vomiting, transient hypotension without shock, injection site erythema, diffuse rash and mild epigastric pain. The limitation is that only immediate post procedure events were actively monitored. CONCLUSIONS: Use of intravenous fluorescein for gastrointestinal CLE appears to be safe with few acute complications.

Esophageal capsule endoscopy vs. EGD for the evaluation of portal hypertension: a French prospective multicenter comparative study.

OBJECTIVES: Esophagogastroduodenoscopy (EGD) is the standard method for the diagnosis of esophago-gastric varices. The aim of this prospective multicenter study was to evaluate the PillCam esophageal capsule endoscopy (ECE) for this indication. METHODS: Patients presenting with cirrhotic or noncirrhotic portal hypertension underwent ECEfollowed by EGD at the time of diagnosis. Capsule recordings were blindly read by two endoscopists. RESULTS: A total of 120 patients (72 males, mean age: 58 years; mean Child-Pugh score: 7.2) were included. Esophageal varices were detected in 74 patients. No adverse event was observed after either EGD or ECE. Seven (6%) patients were unable to swallow the capsule. The mean recording time was 204 s (range 1-876). Sensitivity, specificity, negative predictive value, and positive predictive value of ECE for the detection of esophageal varices were 77%, 86%, 69%, and 90%, respectively. Sensitivity, specificity, negative and positive predictive values of ECE for the indication of primary prophylaxis (esophageal varices > or = grade 2 and/or red signs) were 77, 88, 90, and 75%, respectively, and 85% of the patients were adequately classified for the indication (or not) of prophylaxis. Interobserver concordance for ECE readings was 79.4% for the diagnosis of varices, 66.4% for the grading of varices, and 89.7% for the indication of prophylaxis. CONCLUSIONS: This large multicenter study confirms the safety and acceptable accuracy of ECE for the evaluation of esophageal varices. ECE might be proposed as an alternative to EGD for the screening of portal hypertension, especially in patients unable or unwilling to undergo EGD.

A French prospective observational study of the treatment of chronic hepatitis C in drug abusers.

The objective of this prospective, multicenter, observational study was to evaluate healthcare for hepatitis C virus (HCV)-infected drug abusers in France and to determine predictors of successful therapeutic intervention. A total of 170 drug users were recruited from 40 French centers. Three centers recruited 66 participants (38.8%), and one to eight patients each were enrolled from 37 other centers (n=104). A sustained viral response (SVR) was seen in 65 (38.2%) patients. SVR rates were significantly higher in compliant than in non-compliant patients (43.5% versus 23.9%; P=0.019), in patients from high- rather than low-recruiting centers (54.5% versus 27.9%; P<0.001) and in patients receiving Buprenorphine rather than methadone (48.1% versus 21.8%; P=0.001). In patients, who completed both the treatment and follow-up (n=94), SVR rate was 57.4%. Buprenorphine substitution therapy and genotypes 2 or 3 HCV infection were associated with significantly higher rates of SVR (P<0.01, for both comparisons). In conclusion, successful care of hepatitis requires an active treatment policy of every center toward drug addicts. Additional studies are needed to explore the difference in SVR with methadone versus Buprenorphine therapy.

[Hepatitis C, cirrhosis and hepatocellular carcinoma]. / Hépatite C, cirrhose et carcinome hépatocellulaire.

The screening for the detection of hepatocellular carcinoma is based on ultrasound sonography which should be realised in patients with post-hepatitis C cirrhosis with a delay between 3 and 6 months according to the most identified risk factors, in particular age and sex male. In the case of discovery of hypoechogen nodule < or = 1cm, a follow-up is mandatory because it is usually untypical by ultrasound sonography and to propose a liver biopsy in the case of an increasing in size is shown. The ultrasound guided cutting biopsy can precise the histological characteristics of the nodule, the grade, and indicate prognostic factors. The liver biopsy is also mandatory in the case of a nodule > 2 cm and when the ultrasound sonography is not contributive, especially when the nodule is between 1 and 2 cm in size.

The efficacy and safety of duodenal stenting: a prospective multicenter study.

BACKGROUND AND STUDY AIMS: Duodenal stenting has become a popular treatment in cases of malignant stenosis. However, a prospective evaluation of the efficacy and morbidity of this procedure has not been performed. A prospective multicenter study of duodenal stenting was conducted by the Société Française d'Endoscopie Digestive (SFED). PATIENTS AND METHODS: A total of 51 patients were selected (mean age 72), the majority (69%) having pancreatic adenocarcinoma. Palliative treatment was chosen because of irresectability (61.2%), inoperability (18.4%), or both (20.4 %). Enteral Wallstent prostheses were used, and the patients were followed up on day 3, after 1 month, and then every month, with weight measurement, and symptomatic and laboratory evaluation. RESULTS: One prosthesis was sufficient in 46 patients. Stent positioning and deployment were correct in 50/51 patients (98%). Twenty patients also underwent biliary stenting in addition to the duodenal stenting. On day 3, 43 patients (84%) were able to tolerate soft solids or a full diet. Six complications were attributed to stenting: three intestinal hemorrhages, two cases of peritonitis due to bowel perforation, and one case of septicemia, and these led to five deaths (mortality 9.8%). Stent dysfunction was observed in 12 cases (23.5%) after a mean delay of 75 days, comprising 11-malignant obstructions and one migration: a new stent was inserted inside the first one and was effective in eight cases; and no treatment was given in the other four patients because of their clinical state. The median survival was 71.5 days. CONCLUSIONS: Palliative endoscopic treatment of malignant duodenal stenosis using metallic prostheses is highly feasible, even with associated biliary stenting. Symptomatic improvement is fast. However, the mortality and the obstruction rate are high, suggesting that a prospective trial comparing this treatment with surgery is still required.

[Incidence and risk factors of HCV infection in a cohort of intravenous drug users in the North and East of France]. / Incidence et facteurs de risque de la séroconversion au virus de l'hépatite C dans une cohorte d'usagers de drogue intraveineux du nord-est de la France.

BACKGROUND: In order to evaluate the incidence and risk factors of infection by hepatitis C virus (HCV) among intravenous drug users we conducted a prospective cohort study of HCV and HIV negative IVDU in the North and East of France. METHODS: Two hundred and thirty-one IVDU who had injected drug at least once in their lifetime and were negative for anti-HCV and anti-HIV were followed-up every three months over a 12-month period. Serum anti-HCV and anti-HIV antibodies were tested at inclusion in the study and at the end of the follow-up. Data on injection practices and behaviours were collected at inclusion and at each visit, and a test for anti-HCV antibodies was performed on a saliva sample. When this proved positive, an ELISA test for serum anti-HCV antibodies was carried out. RESULTS: Of the 231 participants included, 165 (71.4%) underwent a final HCV and HIV serum test. The incidence was nil for HIV infection and 9% (95% CI: 4.6-13.4) person-years for HCV infection. Among IVDU who injected at least once during the last 6 months HCV infection incidence was 11% (95% CI: 4.7-17.1) person-years. The multivariate analysis carried out on the inclusion data found female sex alone to be an independent predictive factor of HCV seroconversion. In a Cox proportional hazard multivariate analysis that took into account time-dependent exposures and covariates, we found that syringe and cotton sharing were, after adjusting for other covariates, the only independent predictive factors of HCV seroconversion: hazard ratio: 6.3 [corrected] (95% CI: 1.1-35.4; [corrected] p<0.05) and 16.4 (95% CI: 1.4-190.6; [corrected] p<0.05), respectively. CONCLUSION: The transmission of the HCV virus persists among French IVDU despite an ongoing national harm reduction program. Injecting material and cotton sharing are the two major determinants of transmission in this cohort.

Incidence and risk factors of HCV and HIV infections in a cohort of intravenous drug users in the North and East of France.

In order to evaluate the incidence and risk factors of infection by hepatitis C virus (HCV) among injecting drug users (IDUs), we conducted a prospective cohort study of HCV- and human immunodeficiency virus (HIV)-negative IDUs in the North and East of France. A total of 231 HCV and HIV IDUs who had injected drugs at least once in their lifetime were followed up every 3 months over a 12-month period. Serum anti-HCV and anti-HIV were tested at inclusion in the study and at the end of the follow-up. Data on injecting practices were collected at inclusion and at each visit. Of the 231 participants included, 165 (71.4%) underwent a final HCV and HIV serum test. The incidence was nil for HIV infection and 9/100 person-years (95% CI 4.6-13.4) for HCV infection. In a multivariable analysis, we found that syringe and cotton sharing were the only independent predictive factors of HCV seroconversion.

[Feasibility of prosthesis insertion by laparotomy as palliative treatment for malignant duodenal stenosis]. / Faisabilité de l'insertion des prothèses par laparotomie comme traitement palliatif des sténoses duodénales malignes.

The authors report a preliminary series assessing the feasibility of duodenal stenting using a surgical approach. The study included 16 patients with a malignant duodenal outlet obstruction for whom a biliaryobstruction necessitated a laparotomyor following an endoscopic stenting failure. The stent was efficient in 15 patients with a complete relieve of obstruction. These patients could have oral intake at the end of the first postoperative week. No stent obstruction occurred. The duodenal stenting by laparotomy could be a good alternative to palliative gastroenteral anasotomosis.

[Patients with alcoholic liver disease hospitalized in gastroenterology. A national multicenter study]. / Maladies alcooliques du foie hospitalisées en Hépato-Gastroentérologie. Enquête multicentrique nationale.

OBJECTIVES: To describe the characteristics of in-patients with alcoholic liver disease in Hepatogastroenterology and to evaluate whether geographic location was a risk factor for cirrhosis. METHODS: A French, national, multicenter, prospective investigation was performed in the last quarter of 1997. To be included in the study, patients had to have drunk at least 50 g of alcohol per day for the past year or to have cirrhosis. RESULTS: Seventeen centers included 802 patients, 20% had histologically proven cirrhosis or probable cirrhosis. Thirty-five percent had undergone liver biopsy. Twenty five percent of these patients had cirrhosis without acute alcoholic hepatitis and 37% had cirrhosis with acute alcoholic hepatitis. After dividing France along a Bordeaux-Strasbourg axis, there was more histologically proven or probable cirrhosis in the North (46%) than in the South (36%) (P<0.005) while daily alcohol intake was greater the South (150 +/- 6 g) than in the North (129 +/- 4 g) (P<0.0001). When the six variables (age, sex, daily consumption of alcohol over the past 5 years, presence of hepatitis B surface antigen and antibodies to hepatitis C virus, total duration of alcohol abuse) were considered together in stepwise logistic regression analysis, geographic location changed the prediction of cirrhosis. The odds ratio for cirrhosis in patients living to the North of the Bordeaux-Strasbourg axis was 1.9 (95% confidence interval range 1.1-3.2) (P<0.02), suggesting the role of nutritional factors.

Noninvasive imaging of insulinomas and gastrinomas with endoscopic ultrasonography and somatostatin receptor scintigraphy.

BACKGROUND: Classic morphological techniques are of limited value for imaging endocrine duodenopancreatic tumors, and invasive procedures such as intraarterial stimulation are often used. Two noninvasive procedures, endoscopic ultrasonography (EUS) and somatostatin receptor scintigraphy (SRS), were recently described with promising results. METHODS: In this study we correlated the results of preoperative EUS (n = 34) and SRS (n = 30) with operative findings in patients with histologically proven insulinoma (n = 20) or gastrinoma (n = 21). RESULTS: The sensitivity and positive predictive value (PPV) of EUS were respectively 77% and 94% for pancreatic tumors (insulinomas and gastrinomas), 40% and 100% for duodenal gastrinomas, and 58% and 78% for metastatic lymph nodes. The sensitivity and PPV of SRS for insulinoma were 60% and 100%, respectively. In patients with gastrinoma, the sensitivity and PPV of SRS were respectively 25% and 100% for pancreatic gastrinomas, 72% and 100% for duodenal gastrinomas or periduodenal metastatic lymph nodes, and 67% and 80% for liver metastasis. In patients with multiple endocrine neoplasia, neither one of the two techniques detected all tumors. Overall sensitivity of combined EUS and SRS was 89% for insulinoma (n = 9) and 93% for gastrinoma (n = 14). CONCLUSIONS: EUS and SRS for gastrinomas and insulinomas should be considered as the initial preoperative imaging procedures and may render invasive procedures unnecessary for most patients.

[Rapid progress of cirrhosis in hepatitis C: the role of age at the time of viral contamination]. / Rapidité d'évolution vers la cirrhose après hépatite C: influence de l'âge au moment de la contamination par le virus.

OBJECTIVE: The aim of this study was to assess predictive factors for the progression to liver cirrhosis in hepatitis C. METHODS: One hundred thirty six patients (79 men; 57 women; mean age 39 years) with transfusion or intravenous drug use-associated hepatitis C virus (HCV) infection were studied. Sex, cause of infection, duration of contamination, and genotype were studied as predictive factors of progression to liver cirrhosis. RESULTS: One hundred twenty three patients presented with chronic hepatitis without cirrhosis and 13 had cirrhosis. At the time of liver biopsy, rates of cirrhosis were: 0% before 40 years, 10% between 40 and 60 years, and 47% after 60 years. (p < 0.05). Rates of cirrhosis according to the age at the time of contamination were as follows: 3% before 30 years; 16% between 30 and 50 years; 46% after 50 years even though duration of the disease was comparable in the three groups. In multivariate analysis, two independent factors were associated with liver cirrhosis: age at contamination and duration of infection. CONCLUSION: Duration of infection and especially age at contamination seem better correlated with the probability of cirrhosis than the route of transmission or the genotype 1b. The results of this study suggest that progression to cirrhosis is slower in cases of contamination before 30 years of age than later on. Age at the time of contamination is an important predictive factor of progression to cirrhosis.

Efficacy and tolerance of mesalazine suppositories vs. hydrocortisone foam in proctitis.

BACKGROUND: Topical treatments with steroids or mesalazine are the most effective treatments for idiopathic proctitis. AIM: To compare the efficacy and tolerance of mesalazine suppositories vs. hydrocortisone acetate foam in the treatment of acute proctitis. PATIENTS AND METHODS: 242 patients with active idiopathic proctitis were randomized to receive once daily either one Pentasa suppository (mesalazine 1 g) or 100 mg hydrocortisone (Colofoam) for 14-21 days (until remission). Disease activity and tolerance of the treatments were assessed using a daily questionnaire, by physician assessment, and endoscopy score. RESULTS: Both treatments induced a significant reduction in disease activity. Mesalazine suppositories were significantly more effective than hydrocortisone on rectal blood loss (P = 0.002) and mucus (P = 0.02) parameters, and on the degree of the decrease in endoscopy score (P = 0.02). No significant difference was observed between treatments concerning histology or tolerance. CONCLUSION: Mesalazine suppositories were as well-tolerated as hydrocortisone foam, but were more effective for some parameters of disease activity.