[Diagnosis of Helicobacter pylori infections using isotope-selective non dispersive infrared spectrometry with 13C-urea breath test]. / Diagnosi di infezione da Helicobacter pylori mediante spettrometria a raggi infrarossi isotopo-selettiva non dispersiva con 13C-Urea Breath Test.

OBJECTIVE: The 13C-Urea Breath Test (13C-UBT) is a non-invasive simple and reliable test for the diagnosis of Helicobacter pylori infection. Widespread use of the test is limited by the high cost of isotope-ratio mass-spectrometry that is required for analysis of the breath samples. The aim of our study was: 1) evaluate the accuracy of a simple optical method called isotope-selective non-dispersive infrared spectrometry (NDIRS), which is designed to measure 13CO2/12CO2 ratio; 2) evaluate the possibility to reduce timing of breath samples collection after 13C-urea ingestion. METHODS: 13C-UBT and gastroscopy were performed in one hundred patients (mean age: 51 years; range: 18-81 years; M/F: 48/52) after overnight fasting. None had taken antibiotics, proton pump inhibitor or bismuth-containing preparations for at least four weeks. Two biopsies from the antrum and two from the body of the stomach were obtained from each patient to investigate the Helicobacter pylori status. Breath samples were collected from each patient in aluminised plastic bags with a volume of 1200 ml, before and 10, 20 and 30 minutes after ingestion of 75 mg 13C-urea dissolved in 200 ml of orange juice. A value of "Delta-Over-Baseline" higher than 4@1000 was considered positive. The operators of each device were unaware of Helicobacter pylori status. RESULTS: 54/55 patients resulted positive on 13C-UBT in respect of immunohistochemistry. 44/45 patients resulted negative on 13C-UBT in respect of immunohistochemistry. The sensibility resulted 98.1%, specificity 97.7%. No significant difference between sample collection at 10, 20 or 30 minutes after ingestion of 13C-urea was found (Chi square: p: n.s.). DISCUSSION: This study shows that the diagnostic accuracy of infrared spectroscopy is excellent and comparable with data of other authors about conventional isotope-ratio mass spectrometry. No significant difference between sample collection at 10, 20 or 30 minutes after ingestion of 13C-urea was found (Chi square: p: n.s.). Timing of sample collection may be reduced from 30 to 10 minutes with the purpose of cut down more the costs for this test.

Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.

BACKGROUND: There is a lack of multicenter prospective studies on complications of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We studied 2769 consecutive patients undergoing ERCP at nine centers in the Triveneto region of Italy over a 2-year period. Six centers performed ERCP on less than 200 patients per year (small centers). General and ERCP-specific major complications were predefined. Data were collected at the time of ERCP, before discharge, and in cases of readmission within 30 days. ERCP was defined as therapeutic when endoscopic sphincterotomy (n = 1583), precut (n = 419), or drainage (n = 701) had been carried out, singularly or in combination. RESULTS: One hundred eleven major complications (4.0%) were recorded: moderate-severe pancreatitis 36 (1.3%), cholangitis 24 (0.87%), hemorrhage 21 (0.76%), duodenal perforation 16 (0.58%), others 14 (0.51%). Among 942 diagnostic ERCPs there were 13 major complications (1.38%) and 2 deaths (0.21%), whereas among 1827 therapeutic ERCPs there were 98 major complications (5.4%) and 9 deaths (0.49%). The difference in the incidence of complications between diagnostic and therapeutic ERCPs was statistically significant (p < 0.0001). Small center and precut were recognized as independent risk factors for overall major complications of therapeutic ERCP, whereas the following risk factors were identified in relation to specific complications: (1) pancreatitis: age less than 70 years, pancreatic duct opacification, and nondilated common bile duct; (2) cholangitis: small center, jaundice; (3) hemorrhage: small center; and (4) retroperitoneal duodenal perforation: precut, intramural injection of contrast medium, and Billroth II gastrectomy. CONCLUSIONS: Major complications are mostly associated with therapeutic procedures and low case volume. Present data support a policy of centralization of ERCP in referral centers. A more selected and safer use of precut may be expected to further limit the adverse events of ERCP.