Fabrizio Cardin

Outcome of patients receiving photodynamic therapy for early esophageal cancer

PURPOSE Photodynamic therapy (PDT) has shown remarkable activity in a variety of human cancers. In the present study, we report the effects of PDT on inoperable early-stage esophageal cancer. METHODS AND MATERIALS Sixty-two patients were treated with an argon dye laser (630 nm wavelength, 300-800 mW of power, energy dose of 200-300 J/cm) after intravenous injection of 5 mg/kg of hematoporphyrin derivative. Eighteen patients (29.5%) had in situ carcinoma (Tis), 30 (48.5%) had T1-stage cancer, 7 (11%) had T2-stage cancer, and 7 (11%) had recurrent disease in the anastomotic area after previous surgery without evidence of invasion outside the lumen. Patients with residual disease after two rounds of PDT received definitive radiotherapy. Patients were evaluated for response to therapy and survival. The follow-up time ranged from 3 to 90 months (median, 32 months). RESULTS The complete response (CR) rate was 37% (23 of 62) in patients who received PDT alone and 82% (51 of 62) in those who also received radiotherapy. The CR rate after PDT alone was statistically higher (p = 0.04) for patients who had Tis/T1 lesions (21 of 48; 44%) than for those with T2-stage disease (2 of 7; 28%) or recurrent tumors (0 of 7; 0%). Fifty-two percent of patients who had CR following PDT alone did not suffer local tumor recurrence. The median local progression-free survival times after PDT and additional radiotherapy (in cases with incomplete response) was 49 months for Tis- and T1-stage lesions, 30 months for those with T2-stage disease, and 14 months for patients with locally recurrent disease. Patients who completely responded to PDT had a median overall survival (OS) of 50 months, which was significantly longer (p < 0.003) than that of patients not responding to PDT. Toxicity was minimal; we recorded three cases of esophageal stenosis (7%) and one case of tracheo-esophageal fistula (2.5%) after combined PDT and radiotherapy. CONCLUSION PDT is an effective regimen for early esophageal cancer, giving a CR rate of about 40%, long-term local control and favorable overall survival. Additional radiotherapy in cases of incomplete response to PDT is effective and potentially curative in another 45% of cases.

Constipation in the acutely hospitalized older patients.

The aim of this work was to establish the factors that determine the onset of constipation in acutely hospitalized older patients with a view to contributing towards an evidence-based identification of which patients warrant early, specific preventive measures. To evade the problem posed by the definition of constipation, we have considered parameters that are part of the daily routine in the hospital ward, such as the prescription of laxatives, also paying attention to how the co-operative older person subjectively interpret this condition. One thirds of the 192 hospitalized older patients needed a laxative at least once every 3 days. Multivariate analysis identified the use of laxatives at home as the only risk factor for objective constipation while in hospital (odds ratio (OR)=3.0). A significant risk of being dissatisfied with their bowel emptying emerged among patients who were bedridden for more than 2 weeks (OR=6.0), and in those who experienced cerebrovascular events (OR=3.1). The use of laxatives at home and awareness that satisfaction with bowel movements drops in patients obliged to stay in bed for lengthy periods of time and in those who have suffered cerebrovascular damage, should provide the grounds for a screening program to establish rational guidelines on bowel movement therapy.

Ischemic colitis in the elderly: predictors of the disease and prognostic factors to negative outcome.

Abstract Objective. Ischemic colitis (IC) poses a challenge for physicians, especially in elderly patients. The aim of this study was to identify predictors of the disease and to assess the factors predicting its evolution in elderly people. Material and methods. A retrospective study was undertaken in patients with IC admitted to Padua General Hospital between 2003 and 2008. Only patients with biopsy-proven IC were considered. Fifty control subjects were randomly selected from those seen at our units for acute geriatric disease during the same interval. Patients with IC were classified as having either a positive or negative outcome. Results. A total of 46 patients were considered. The risk factors for IC identified from univariate analysis were analyzed in a multivariate logistic regression model and constipation [adjusted odds ratio (OR) 4.8; 95% confidence interval (CI) 1.1–20.1], vasculopathy (OR 4.9; 95% CI 1.4–16.6), hepatitis C virus (HCV) (OR 9.9; 95% CI 1.1–92.9) and cancer (OR 7.5; 95% CI 2.1–26.9) confirmed their independent significance as risk factors. Hematochezia was predictive of a positive outcome (OR 0.07; 95% CI 0.02–0.40), while cancer (OR 3.2; 95% CI 1.2–11.9), HCV positivity (OR 9.6; 95% CI 1.6–56.5), signs of peritonism (OR 4.7; 95% CI 1.2–18.4), localization in the right colon (OR 5.75; 95% CI 1.5–21.9) and increased levels of lactate dehydrogenase (LDH) and urea were independently predictive of a negative outcome. Conclusions. Elderly patients with IC are characterized by significant comorbidities. The absence of hematochezia and the presence of a concomitant malignancy, HCV, a marked increase in urea and LDH and disease involving only the right colon are factors that may predict a negative outcome in elderly patients.

Morpho-functional gastric pre-and post-operative changes in elderly patients undergoing laparoscopic cholecystectomy for gallstone related disease

BackgroundCholecystectomy, gold standard treatment for gallbladder lithiasis, is closely associated with increased bile reflux into the stomach as amply demonstrated by experimental studies. The high prevalence of gallstones in the population and the consequent widespread use of surgical removal of the gallbladder require an assessment of the relationship between cholecystectomy and gastric mucosal disorders.Morphological evaluations performed on serial pre and post – surgical biopsies have provided new acquisitions about gastric damage induced by bile in the organ.Methods62 elderly patients with gallstone related disease were recruited in a 30 months period. All patients were subjected to the most appropriate treatment (Laparoscopic cholecystectomy). The subjects had a pre-surgical evaluation with:• dyspeptic symptoms questionnaire,• gastric endoscopy with body, antrum, and fundus random biopsies,• histo-pathological analysis of samples and elaboration of bile reflux index (BRI).The same evaluation was repeated at a 6 months follow-up.ResultsIn our series the duodeno-gastric reflux and the consensual biliary gastritis, assessed histologically with the BRI, was found in 58% of the patients after 6 months from cholecystectomy. The demonstrated bile reflux had no effect on H. pylori’s gastric colonization nor on the induction of gastric precancerous lesions.ConclusionsCholecystectomy, gold standard treatment for gallstone-related diseases, is practiced in a high percentage of patients with this condition. Such procedure, considered by many harmless, was, in our study, associated with a significant risk of developing biliary gastritis after 6 months during the postoperative period.

Are Dyspepsia Management Guidelines Coherent with Primary Care Practice

Background: Spontaneous physician behaviour can affect guideline applicability, implementation strategies and application costs, particularly in relation to widespread pathologies chiefly managed by general practitioners (GPs). Of the array of dyspepsia management guidelines, the closest to general practice, partly owing to proposing committee composition, are the European Society for Primary Care Gastroenterology (ESPCG) guidelines. Methods: To evaluate variability in dyspepsia management among GPs in Padua and divergence in spontaneous prescriptive behaviour from the ESPCG dyspepsia guideline, we prospectively studied the behaviour of 39 GPs over a 3-month period of outpatient activity, through questionnaires on each consultation. Test-group representativeness was preliminarily defined in terms of antisecretory drug expenditure. Results: 1790 forms on dyspepsia-related consultations were studied in a population of 51,193 registered patients; 1264 patients with a history of dyspeptic pathology consulted their GP (19% duodenal ulcer (DU), 9% gastric ulcer (GU), 54% gastro-oesophageal reflux disease (GERD), 32% non-ulcer dyspepsia (NUD), 1% cholelithiasis), while 526 patients presented with symptoms of dyspepsia with no previous gastroscopy (EGDS) (42% were aged <45 years), of whom 42% had twice consulted their GP. Empirical management by prescription of symptomatic drugs was the most common procedure in DU (33%), GU (73%) and NUD (74%) relapses. Helicobacter pylori eradication therapy was prescribed in only 2% of patients with a history of organic or functional dyspepsia. 145 patients with uninvestigated dyspepsia were referred for second-level endoscopy and 43 for H. pylori testing. Forty-four percent of endoscopies prescribed for uninvestigated patients did not comply with the ESPCG guideline; full compliance would have determined a 105% rise in endoscopies. Prescriptive variability between GPs was high (based on the Goodman-Kruskal (0.41, P < 0.001) and Cramer tests (V = 0.51, P < 0.005)) and agreement between observed and expected prescriptions according to ESPCG criteria was as low as V = 0.11. On the basis of the most frequently observed behaviours, we developed three options of the ESPCG guideline and compared them to spontaneous prescriptions. Conclusions: Highest compliance emerged where the clinical approach for all patients with uninvestigated dyspepsia was symptomatic therapy at first presentation followed by a different attitude at second presentation, setting a higher cut-off age than in the guideline (which in our case proved, on mathematical calculation, to be 55 years).

Esophagitis in frail elderly people.

Introduction We studied the clinical course of elderly patients acutely hospitalized for various diseases, assessing any differences between patients with and without esophagitis. Study A case-control study on the presence of esophagitis was conducted on the clinical records of all in-patients undergoing gastroduodenoscopy at Padova Geriatric Hospital from 1997 to 2001. Data were examined on 338 sex-matched patients: 169 with a diagnosis of esophagitis and 169 with a negative endoscopy. Results Admissions for acute respiratory disorders [odds ratios (OR) 2.68; 95% confidence interval (CI) 0.89-8.01], a remote diagnosis of esophagitis (OR 11.34; 95%CI 2.68-48.07), obesity (OR 3.36; 95%CI 0.91-12.48), and being bedridden (OR 6.84; 95%CI 3.27-14.29) were found to be independent risk factors for the presence of esophagitis. The symptoms prompting the endoscopic diagnoses included: gastrointestinal bleeding (OR 7.61; 95%CI 2.76-21.0), heartburn (OR 4.58; 95%CI 1.86-11.28), and cough (OR 3.59; 95%CI 1.34-9.62). Steroids (OR 2.68; 95%CI 1.11-6.44) and calcium antagonists (OR 1.50; 95%CI 0.79-2.87) were associated with esophagitis as risk factors, whereas proton pump inhibitors (OR 0.46; 95%CI 0.25-0.87), nitrates (OR 0.14; 95%CI 0.02-0.78), and sucralfate in males (OR 0.09; 95%CI 0.01-0.92) were associated as protective factors. Patients with esophagitis were discharged with an endocrinologic/metabolic-type diagnosis. Deaths were significantly higher among patients with esophagitis (25 vs. 9); more severe esophagitis was characterized by a higher Charlson comorbidity index and a greater presence of anorexia and nausea. Conclusions These findings seem to substantiate the theory that esophagitis is a characteristic which exacerbates frailty in hospitalized elderly people and its identification may be helpful in these patients.

Quality of life and depression in a cohort of female patients with chronic disease

BackgroundDifferences in health-related quality of life perception in patients with chronic disease may depend on pre-existing differences in personality profile. The purpose of the study was to investigate in a cohort of female patients with chronic diseases the relationship between the Quality of Life perception and the potential presence of depressive symptoms.Patients and methodsFemale patients with chronic diseases were enrolled in the study. Exclusion criteria were diagnosis of psychopathological condition, treatment with psychoactive substances.Methodological approach was based on administration of the following test. Short Form health survey SF-36, Symptom Check List SCL-90-R, Satisfaction Profile test (SAT-P) and Beck Depression Inventory-II (BDI-II). The Pearson correlation coefficient was used to evaluate the relationship between depressive symptoms and Quality of life as assessed by psychometric test.Results57 patients, aged 52(±3,4), responded to inclusion criteria. 57% of patients had a diagnosis of functional dyspepsia or gastro-oesophageal reflux not complicated, and the remaining 43% musculoskeletal diseases. The statistical analysis showed an inverse correlation between the variable Bodily Pain of the SF-36 and the variable Depression scales of the SCL-90-R.In a second phase another sample of female patients was enrolled in the study. 64 patients, aged 49(±3,2), responded to inclusion criteria.Another significant negative correlation was found between the Somatic-Affective factor of the BDI-II and the scale Physical Functioning of the SAT-P.DiscussionsIn female patients with chronic disease depressive symptoms resulted influenced by pain and vice versa. The treatment of depressive symptoms could improve the quality of life of patients.

Ethical and medico-legal implications of capacity of patients in geriatric surgery.

Objectives The aim of this study was to assess the decision-making capacity of elderly patients hospitalized in a geriatric surgery division, and the clinician’s ability to assess that capacity. Subjects and methods The study was conducted on patients (aged >66 years) undergoing surgical procedures. Exclusion criteria were a diagnosis of psychogeriatric disorders interfering with decision-making capacity; hearing or visual impairment; and inability to communicate. Patients previously declared legally incompetent were also excluded. The methodological approach consisted of additional interviews to collect data on patients’ awareness of the reasons for their hospitalization, their informed consent, and their ability to sign a consent form. The interview was integrated with a clinical-behavioral assessment by means of the Mini-Mental State Examination and the Clock Drawing Test. Data were collected anonymously. Results The inclusion criteria were met by 123 patients, with a mean age ± SD of 77.65 ± 7.91 years (range 67–98). Their mean (±SD) Mini-Mental State Examination and the Clock Drawing Test scores were 24.53 ± 4.29 and 5.36 ± 2.41, respectively. Mild-to-severe cognitive impairment was identified in 39 patients (31.7%). The consent form was signed by 111 patients (90.25%), including 33 patients (29.72%) with mild-severe cognitive impairment; 18 patients (16.21%) were unaware of the reason for their admission to hospital. Discussion Many factors may interfere with elderly patients’ ability to give their valid consent to treatment, and this study reveals that clinicians may overestimate their patients’ decision-making capacity. Physicians should be aware of this problem, and intellectual capacity assessments and/or enhanced consent procedures should be considered when treating elderly patients.

Difficult colonoscopies in the propofol era

BackgroundTo study the relationship between endoscopic practice and adverse events during colonoscopy under standard deep sedation induced and monitored by an anesthetist.MethodsWe investigated the routine activity of an endoscopy center at the Padova University teaching hospital. We considered not only endoscopic and cardiorespiratory complications, but also the need to use high-dose propofol to complete the procedure, and the inability to complete the procedure. Variables relating to the patient’s clinical conditions, bowel preparation, the endoscopist’s and the anesthetist’s experience, and the duration of the procedure were input in the model.Results617 procedures under deep sedation were performed with a 5% rate of adverse events. The average dose of propofol used was 2.6±1.2 mg/kg. In all, 14 endoscopists and 42 anesthetists were involved in the procedures. The logistic regression analysis identified female gender (OR=2.3), having the colonoscopy performed by a less experienced endoscopist (OR=1.9), inadequate bowel preparation (OR=3.2) and a procedure lasting longer than 17.5 minutes (OR=1.6) as the main risk factors for complications. An ASA score of 2 carried a 50% risk reduction (OR=0.5).Discussion and conclusionsOur model showed that none of the variables relating to anesthesiological issues influenced which procedures would prove difficult.

Usefulness of a fast track list for anxious patients in a upper GI endoscopy

BackgroundTo determine whether patients with no alarm signs who ask the endoscopist to shorten their waiting time due to test result anxiety, represent a risk category for a major organic pathology.MethodsAt our open-access endoscopy service, we set up an expedite list for six months for outpatients who complained that the waiting time for gastroscopy was too long. Over this period we studied 373 gastroscopy patients. In addition to personal details, we collected information on the presence of Hp infection and compliance with dyspepsia guideline indications for gastroscopy.ResultsAverage waiting time was 38.2 days (SD 12.7). The 66 patients who considered the waiting time too long underwent gastroscopy within 15 days. We made 5 diagnoses of esophageal and gastric tumour and gastric ulcer (7.6%) among the expedite list patients and 14 (4.6%) among those on the normal list (p=0.31). On including duodenal peptic disease in the analysis, the total prevalence rate rose to 19.7% in the short-wait group and to 10.4% (p=0.036) in the longer-wait group.Discussion and conclusionsOur data suggests that asking to be fast-tracked does not have prognostic impact on the diagnosis of a major (gastric ulcer and cancer) pathology.