Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay.

The noninvasive detection of Helicobacter pylori and its resistance to clarithromycin could revolutionize the management of H. pylori-infected patients by tailoring eradication treatment without any need for endoscopy when histology is not necessary. Several real-time PCR tests performed on stools have been proposed, but their performances were either poor or they were tested on too few patients to be properly evaluated. We conducted a prospective, multicenter study including 1,200 adult patients who were addressed for gastroduodenal endoscopy with gastric biopsies and who were naive for eradication treatment in order to evaluate the performance of the Amplidiag H. pylori+ClariR assay recently developed by Mobidiag (Espoo, Finland). The results of the Amplidiag H. pylori+ClariR assay performed on DNA from stools (automatic extraction with the EasyMag system [bioMérieux]) were compared with those of culture/Etest and quadruplex real-time PCRs performed on two gastric biopsy samples (from the antrum and corpus) to detect the H. pyloriglmM gene and mutations in the 23S rRNA genes conferring clarithromycin resistance. The sensitivity and specificity of the detection of H. pylori were 96.3% (95% confidence interval [CI], 92 to 98%) and 98.7% (95% CI, 97 to 99%), respectively. The positive and negative predictive values were evaluated to be 92.2% (95% CI, 92 to 98%) and 99.3% (95% CI, 98 to 99%), respectively. In this cohort, 160 patients (14.7%) were found to be infected (positive by culture and/or PCR). The sensitivity and specificity for detecting resistance to clarithromycin were 100% (95% CI, 88 to 100%) and 98.4% (95% CI, 94 to 99%), respectively.

Analysis of factors influencing molecular testing at diagnostic of colorectal cancer.

BACKGROUND: The aim of the study was to evaluate the current rate of molecular testing prescription (KRAS codons 12/13, BRAF and microsatellite instability (MSI)) in newly diagnosed colorectal cancer (CRC) patients and to determine which factors influence testing. METHODS: All incident CRC cases in 2010 were identified in the Poitou-Charentes General Cancer Registry. The exhaustive molecular testing performed was accessed in the French molecular genetics platform. Factors influencing prescription were analyzed using logistic regression. RESULTS: Among the 1269 CRCs included in the study, KRAS, BRAF and MSI testing accounted for 35.1%, 10.5% and 10.9%, respectively. KRAS testing was carried out in 65.5% of metastatic CRCs, and 26.1% of non-metastatic CRCs. Among metastatic CRCs, age (<60 years), site of primary tumour (left colon) and geographical area of treatment were factors related to KRAS testing. BRAF testing was contemporary to KRAS testing for 92.5% of patients. Factors related to MSI testing were age (<60 years), TNM stage (stage IV) and geographical area of treatment. Among CRC patients under 60 years old, only 37.5% had MSI testing. CONCLUSION: These results underscore the need to reduce disparities in CRC molecular testing and highlight the limited application of the French guidelines, especially concerning MSI testing.

Prognosis of variceal and non-variceal upper gastrointestinal bleeding in already hospitalised patients: Results from a French prospective cohort.

OBJECTIVES: Patients who develop upper gastrointestinal bleeding (UGIB) while in hospital appear to have a poor prognosis. Our study aims at analysing the difference in outcome between in-patients (IPs) and out-patients presenting with variceal and non-variceal UGIB. METHODS: We conducted a multicentre prospective study by collecting data about variceal and non-variceal UGIB cases through 46 hospitals in France between November 2017 and October 2018. We then compared baseline demographic features, endoscopic findings and outcome between patients who developed variceal and non-variceal UGIB on admission (OPs) and those at least 24 h after hospitalisation (IPs). Our primary end-point was mortality and re-bleeding rates at 6 weeks of bleeding onset. RESULTS: A total of 2498 UGIB cases were identified, of whom 634 (25.4%) occurred in IPs. IPs were older than OPs (72.5 vs. 67.2 years old, p < 0.001) and had a higher rate of comorbidities (38.9% vs. 26.6%, p < 0.0001). Their bleeding was more severe with a Rockall score of >5 present in 40.9% (vs. 30.3% in OPs, p < 0.0001). The 6-week mortality rate was significantly higher in IPs when compared to OPs (21.7% vs. 8%, p < 0.0001). Prothrombin time <50% and rebleeding were the only independent predictors of mortality (p = 0.001 and 0.003, respectively). Six-week rebleeding occurred more frequently among IPs (18.6% vs. 14.4%, p = 0.015) and predictors included female sex, active bleeding upon endoscopy and a Blatchford score >11 (p = 0.017, 0.011 and 0.008, respectively). CONCLUSION: IPs who develop variceal and non-variceal UGIB are more likely to be elderly with more comorbidities. They have a higher rate of mortality and rebleeding. Independent predictors of mortality were underlying coagulopathy and bleeding recurrence. An optimal bleeding management and efficient rebleeding prevention may improve outcome in these patients.