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1.
J Clin Gastroenterol ; 53(7): 530-534, 2019 08.
Article in English | MEDLINE | ID: mdl-30720576

ABSTRACT

BACKGROUND AND AIMS: An effective bowel preparation is essential for quality colonoscopy. Inadequate preparation results in missed lesions, need for earlier repeat procedures, prolonged colonoscopy duration, an increased likelihood of adverse events, reduced patient satisfaction, and increased costs. The MOTUS GI Pure-Vu System (Tirat Carmel, Israel) is an Food and Drug Administration-cleared device designed to improve visualization in an inadequately prepared colon by facilitating intraprocedural cleaning. We evaluated the efficacy, safety, and usability of the Pure-Vu System in cleansing poorly prepared colons in human subjects. METHODS: In total, 50 patients with poorly prepared colons undergoing colonoscopy were prospectively enrolled to evaluate the Pure-Vu System at 2 clinical sites [Spain (N=41) and Israel (N=9)]. Cleansing quality was measured using the Boston Bowel Preparation Score (BBPS). RESULTS: In total, 50 patients (64% male individuals), mean age 51.9±10.4 years, and mean body mass index of 26.6±3.1 were enrolled. The Pure-Vu System significantly increased the BBPS median score from 5.0 at baseline to 9.0 after the use of Pure-Vu (P<0.0001). Patients with an adequate cleansing level (BBPS≥2 in each colon segment) increased significantly from 31% (15/49) at baseline to 98% (48/49) after use of Pure-Vu (P<0.001). Cecal intubation was achieved in 48/49 (98%) patients. Colonoscopists were satisfied with the Pure-Vu System. No serious adverse events were reported. CONCLUSIONS: The Pure-Vu System was found to be safe, efficacious, and easy to use in cleansing inadequately prepared colons, enabling the colonoscopist to conduct a complete examination.


Subject(s)
Colonoscopy/methods , Colorectal Neoplasms/diagnosis , Therapeutic Irrigation/methods , Adult , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Therapeutic Irrigation/adverse effects
2.
Radiology ; 237(2): 535-40, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16244262

ABSTRACT

PURPOSE: To prospectively evaluate the accuracy of esophagography with barium in diagnosis of esophageal varices (EV) in patients with compensated cirrhosis, with endoscopic gastroduodenoscopy as the reference standard. MATERIALS AND METHODS: In this study, which was approved by the local Helsinki Committee and in which all patients consented to participate, 61 patients with cirrhosis (34 men, 27 women; mean age, 61 years; range, 36-76 years) received a diagnosis clinically or with liver biopsy. In 87% (n = 53) of patients, Child-Pugh classification was A; in 13% (n = 8), Child-Pugh classification was B. They were evaluated with endoscopic gastroduodenoscopy, according to Japanese general criteria. Esophagography was performed within 3 weeks of endoscopic gastroduodenoscopy, and EV were assigned grades as follows: 0, no EV were seen; 1, EV manifested as very mild irregularities of the folds; and 2, the irregularity of the folds (EV) was clearly present. They were also assigned grades for shape and size: grade F0, no EV detected; grade F1, small straight EV; grade F2, slightly enlarged tortuous EV occupying less than one-third of esophageal lumen; and grade F3, large coil-shaped EV that occupied more than one-third of esophageal lumen. The sensitivity and specificity and positive and negative predictive values of esophagography for identification of each grade of EV were calculated separately, as was the 95% confidence interval. RESULTS: All large EV (grades F2 and F3) were diagnosed at esophagography. Sensitivity declined with small EV (grade F1) to 71. The overall sensitivity of esophagography was 89% (95% confidence interval: 75.9%, 96.5%), the overall specificity was 83% (95% confidence interval: 64.5%, 94.7%), the overall positive predictive value was 89%, and the overall negative predictive value was 83% (95% confidence interval: 64.5%, 94.7%). Overall accuracy was 87%. CONCLUSION: Esophagography is highly accurate in diagnosis of EV and can be considered a viable noninvasive alternative for determination of patients who should be selected for prophylactic treatment.


Subject(s)
Barium Sulfate , Endoscopy, Gastrointestinal , Esophageal and Gastric Varices/diagnostic imaging , Liver Cirrhosis/complications , Adult , Aged , Contrast Media , Esophageal and Gastric Varices/diagnosis , Esophageal and Gastric Varices/etiology , Esophagoscopy , Female , Humans , Male , Middle Aged , Prospective Studies , Radiography , Sensitivity and Specificity
3.
Tumori ; 88(6): 500-2, 2002.
Article in English | MEDLINE | ID: mdl-12597146

ABSTRACT

OBJECTIVE: This study evaluated the results of postoperative adjuvant radiotherapy in patients with localized renal cell carcinoma (RCC). PATIENTS: Eighty-six patients (median age, 60 years) with RCC treated by radical nephrectomy were evaluated for the efficacy of postoperative radiotherapy. Twenty-four percent of patients had stage T2, 35% T3a, 36% T3b and 5% T4 disease. Seventy-seven percent had clear cell carcinomas and 23% granular cell or spindle and mixed cell carcinomas. Radiotherapy was given to the renal bed and adjacent lymphatic basin at a median dose of 46 Gy. RESULTS: Thirty-two (37%) patients relapsed: 27 (84%) had systemic relapse only and five (16%) had local and systemic relapse; all patients of the latter group had stage T3b disease. The 10-year disease-free and overall survival was 40% and 42%, respectively. Tumor invasion of the renal vessels and stage of disease were correlated with survival. Side effects of radiotherapy were mainly gastrointestinal, but one patient who received right abdominal irradiation died because of liver failure. CONCLUSION: The results of our study are comparable with those reported in the literature. Since postoperative irradiation did not improve the survival of patients with RCC and showed toxicity, it is not recommended.


Subject(s)
Carcinoma, Renal Cell/radiotherapy , Kidney Neoplasms/radiotherapy , Nephrectomy , Adult , Aged , Carcinoma, Renal Cell/secondary , Carcinoma, Renal Cell/surgery , Disease-Free Survival , Female , Humans , Israel , Kidney Neoplasms/pathology , Kidney Neoplasms/surgery , Male , Middle Aged , Neoplasm Recurrence, Local , Neoplasm Staging , Radiotherapy Dosage , Radiotherapy, Adjuvant , Survival Analysis , Treatment Outcome
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