ABSTRACT
BACKGROUND: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors. METHODS: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed. RESULTS: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5â% (95â% confidence interval [CI] 56.1â%â-â80.8â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%), respectively (Pâ=â0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4â% (95â%CI 66.9â%â-â90.2â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%; Pâ=â0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100â% (95â%CI 94.3â%â-â100â%) vs. 86.4â% (95â%CI 75.0â%â-â94.0â%), respectively (Pâ=â0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95â%CI 0.47â-â0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.
Subject(s)
Endoscopic Ultrasound-Guided Fine Needle Aspiration , Needles/standards , Pancreas , Pancreatic Neoplasms/diagnosis , Specimen Handling , Alloys , Diagnostic Errors/prevention & control , Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects , Endoscopic Ultrasound-Guided Fine Needle Aspiration/instrumentation , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Female , Humans , Male , Middle Aged , Pancreas/diagnostic imaging , Pancreas/pathology , Quality Improvement , Specimen Handling/instrumentation , Specimen Handling/methods , Specimen Handling/standards , Treatment OutcomeABSTRACT
BACKGROUND: Reducing the reading time of capsule endoscopy films is of high priority for gastroenterologists. We report a prospective multicenter evaluation of an "express view" reading mode (Intromedic capsule system). METHODS: Eighty-three patients with obscure gastrointestinal bleeding were prospectively included in 10 centers. All patients underwent small-bowel capsule endoscopy (Intromedic, Seoul, Republic of Korea). Films were read in standard mode, then a second reading was performed in express view mode at a second center. For each lesion, the precise location, nature, and relevance were collected. A consensus reading and review were done by three experts, and considered to be the gold standard. RESULTS: The mean reading time of capsule films was 39.7 minutes (11â-â180 minutes) and 19.7 minutes (4â-â40 minutes) by standard and express view mode, respectively ( P â<â1â×â10 â-â4 ). The consensus review identified a significant lesion in 44/83 patients (53.0â%). Standard reading and express view reading had a 93.3â% and 82.2â% sensitivity, respectively (NS). Consensus review identified 70 significant images from which standard reading and express view reading detected 58 (82.9â%) and 55 (78.6â%), respectively. The informatics algorithm detected 66/70 images (94.3â%) thus missing four small-bowel angiodysplasia. CONCLUSION: The express view algorithm allows an important shortening of Intromedic capsule film reading time with a high sensitivity.
ABSTRACT
OBJECTIVE: To perform a descriptive analysis of patients with chronic hepatitis C based on a local registry of liver biopsies. PATIENTS AND METHOD: Collection of clinical, biological and histological data from all HCV-infected patients who underwent liver biopsy between January 1997 and December 1998 in the Alpes-Maritimes (France). RESULTS: One thousand and fifty six patients including 924 who lived in the Alpes-Maritimes (515 male, 409 female, mean age: 44.9 years old) were included. Intravenous drug use (30.1%) was the major suspected source of infection before blood transfusion (28.2%). Among intravenous drug users, 38% of patients were infected with genotype 1a and 37.4% with genotype 3. The METAVIR fibrosis severity score was distributed as follows: F0: 10.8%, F1: 53.7%, F2: 15.9%, F3: 14.7%, and F4: 4.9%. In a multivariate analysis adjusted for the duration of infection, independent risk factors associated with the severity of fibrosis were age at contamination >=30 years, genotype other than 1a and alcohol intake >=50 g/day. Determination of HCV antibody and liver biopsy were performed an average of 12.5 and 14 years after presumed date of contamination, respectively. CONCLUSIONS: These data provide a clearer view of the impact of this condition in this area and could help to define a comprehensive policy for patient management.