Gabapentin before laparoscopic sleeve gastrectomy reduces postoperative oxycodone consumption in obese patients: a randomized double-blind placebo-controlled trial.

BACKGROUND: Postoperative pain can be prevented. Gabapentin may be effective in this role. Our primary objective was to test the hypothesis that a prophylactic administration of gabapentin in obese patients before surgery has an opioid-sparing effect and reduces postoperative oxycodone consumption more efficiently than placebo. METHODS: The study enrolled 113 patients undergoing laparoscopic sleeve-gastrectomy under general anesthesia. The patients were randomly allocated to the control or gabapentin group and received a single oral dose of gabapentin 1200 mg or a matching placebo 1 h before surgery. RESULTS: The mean time from the end of anesthesia to the commencement of analgesic therapy was 74.3±37.8 minutes in the placebo group and 110.4±65.4 minutes with gabapentin (mean difference: -36, 95% CI: 12 to 40, P=0.0004). The mean 12-hour oxycodone consumption was 31.5±10 mg with placebo and 26.3±10 mg with gabapentin (mean difference: -5.2 mg, 95% CI: -9.08 to -1.35, P=0.0085). The mean NRS pain intensity at 12 hours was 2±0.9 in the placebo group and 1.5±0.9 with gabapentin (mean difference: -0.5, 95% CI: 0.15 to 0.81, P=0.003). CONCLUSIONS: The demand for oxycodone was delayed in the gabapentin group; also, the total 12-hour dose requirement of oxycodone was lower in the gabapentin group.

Increased Rate of Adenoma Detection Associates With Reduced Risk of Colorectal Cancer and Death.

BACKGROUND & AIMS: The quality of endoscopists' colonoscopy performance is measured by adenoma detection rate (ADR). Although ADR is associated inversely with interval colorectal cancer and colorectal cancer death, the effects of an increasing ADR have not been shown. We investigated whether increasing ADRs from individual endoscopists is associated with reduced risks of interval colorectal cancer and subsequent death. METHODS: We performed a prospective cohort study of individuals who underwent a screening colonoscopy within the National Colorectal Cancer Screening Program in Poland, from January 1, 2004, through December 31, 2008. We collected data from 146,860 colonoscopies performed by 294 endoscopists, with each endoscopist having participated at least twice in annual editions of primary colonoscopy screening. We used annual feedback and quality benchmark indicators to improve colonoscopy performance. We used ADR quintiles in the whole data set to categorize the annual ADRs for each endoscopist. An increased ADR was defined as an increase by at least 1 quintile category, or the maintenance of the highest category in subsequent screening years. Multivariate frailty models were used to evaluate the effects of increased ADR on the risk of interval colorectal cancer and death. RESULTS: Throughout the enrollment period, 219 endoscopists (74.5%) increased their annual ADR category. During 895,916 person-years of follow-up evaluation through the National Cancer Registry, we identified 168 interval colorectal cancers and 44 interval cancer deaths. An increased ADR was associated with an adjusted hazard ratio for interval colorectal cancer of 0.63 (95% confidence interval [CI], 0.45-0.88; P = .006), and for cancer death of 0.50 (95% CI, 0.27-0.95; P = .035). Compared with no increase in ADR, reaching or maintaining the highest quintile ADR category (such as an ADR > 24.56%) decreased the adjusted hazard ratios for interval colorectal cancer to 0.27 (95% CI, 0.12-0.63; P = .003), and 0.18 (95% CI, 0.06-0.56; P = .003), respectively. CONCLUSIONS: In a prospective study of individuals who underwent screening colonoscopy within a National Colorectal Cancer Screening Program, we associated increased ADR with a reduced risk of interval colorectal cancer and death.

Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE).

OBJECTIVES: The response rate to initial invitation to population-based primary screening colonoscopy within the NordICC trial (NCT 00883792) in Poland is around 50%. The aim of this study was to compare the effect of a reinvitation letter and invitation to an educational intervention on participation in screening colonoscopy in nonresponders to initial invitation. METHODS: Within the NordICC trial framework, individuals living in the region of Warsaw, who were drawn from Population Registries and assigned randomly to the screening group, received an invitation letter and a reminder with a prespecified screening colonoscopy appointment date. One thousand individuals, aged 55 to 64 years, who did not respond to both the invitation and the reminding letter were assigned randomly in a 1:1 ratio to the reinvitation group (REI) and the educational meeting group (MEET). The REI group was sent a reinvitation letter and reminder 6 and 3 weeks before the new colonoscopy appointment date, respectively. The MEET group was sent an invitation 6 weeks before an educational meeting date. Outcome measures were participation in screening colonoscopy within 6 months and response rate within 3 months from the date of reinvitation or invitation to an educational meeting. RESULTS: The response rate and the participation rate in colonoscopy were statistically significantly higher in the REI group compared with the MEET group (16.5 vs. 4.3%; P<0.001 and 5.2 vs. 2.1%; P=0.008, respectively). CONCLUSION: A simple reinvitation letter results in a higher response rate and participation rate to screening colonoscopy than invitation to tailored educational meeting in nonresponders to previous invitations. (NCT01183156).

Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial.

OBJECTIVE: Suboptimal adenoma detection rate (ADR) at colonoscopy is associated with increased risk of interval colorectal cancer. It is uncertain how ADR might be improved. We compared the effect of leadership training versus feedback only on colonoscopy quality in a countrywide randomised trial. DESIGN: 40 colonoscopy screening centres with suboptimal performance in the Polish screening programme (centre leader ADR ≤ 25% during preintervention phase January to December 2011) were randomised to either a Train-Colonoscopy-Leaders (TCLs) programme (assessment, hands-on training, post-training feedback) or feedback only (individual quality measures). Colonoscopies performed June to December 2012 (early postintervention) and January to December 2013 (late postintervention) were used to calculate changes in quality measures. Primary outcome was change in leaders' ADR. Mixed effect models using ORs and 95% CIs were computed. RESULTS: The study included 24,582 colonoscopies performed by 38 leaders and 56,617 colonoscopies performed by 138 endoscopists at the participating centres. The absolute difference between the TCL and feedback groups in mean ADR improvement of leaders was 7.1% and 4.2% in early and late postintervention phases, respectively. The TCL group had larger improvement in ADR in early (OR 1.61; 95% CI 1.29 to 2.01; p<0.001) and late (OR 1.35; 95% CI 1.10 to 1.66; p=0.004) postintervention phases. In the late postintervention phase, the absolute difference between the TCL and feedback groups in mean ADR improvement of entire centres was 3.9% (OR 1.25; 95% CI 1.04 to 1.50; p=0.017). CONCLUSIONS: Teaching centre leaders in colonoscopy training improved important quality measures in screening colonoscopy. TRIAL REGISTRATION NUMBER: NCT01667198.

Design of the Polish Colonoscopy Screening Program: a randomized health services study.

BACKGROUND AND STUDY AIMS: Colonoscopy screening for colorectal cancer has been implemented without evidence from randomized controlled trials quantifying its benefit and invariably as an opportunistic program, both of which are contrary to the European Union guideline recommendations. The aim of this paper is to describe the rationale and design of the first population-based colonoscopy screening program (PCSP), which was launched in Poland in 2012 as a randomized health services (RHS) study. METHODS: The PCSP is a natural extension of opportunistic colonoscopy screening implemented in 2000. It uses colonoscopy capacity, a quality assurance program, and a network of 92 centers built up during the opportunistic screening phase to develop a countrywide PCSP. Within the PCSP, single screening colonoscopy is offered to a target population aged 55-64 years. The PCSP uses an RHS design, which means that eligible individuals drawn from population registries are randomly assigned to immediate or postponed invitation to screening. Individuals from birth cohorts that will reach the upper age limit for screening before full implementation of the PCSP are randomly assigned, in a 1:1:1 ratio, to "immediate" screening, "postponed" screening, or a "never invited" control group. The RHS design is a natural platform that will evaluate the effectiveness of screening, and compare different age ranges for screening, invitation procedures, and quality improvement interventions. Up to 2015, 24 centers have been developed, with 34.2% geographic coverage and 851,535 individuals enrolled. CONCLUSIONS: The PCSP sets an example for implementation of population-based colonoscopy screening with experimental design to ensure proper evaluation of its effectiveness.

Simplified automated right ventricular overdrive pacing for rapid diagnosis of supraventricular tachycardia.

OBJECTIVES: The purpose of this study was to prospectively evaluate the feasibility and diagnostic value of right ventricular overdrive pacing (RVOP) during supraventricular tachycardia (SVT) using a 2-catheter approach with automatic pacing from the right ventricular inflow (RVIT) and outflow tract (RVOT). METHODS: One hundred and thirty-six consecutive patients (with 138 arrhythmias, mean age 36 ± 20 years, range 4-95) were enrolled in this study. Only coronary sinus and ablation catheters were used. RVOP was delivered from RVIT and then from RVOT. Each attempt consisted of 10 synchronized beats delivered at a cycle length of 10-40 ms longer than the tachycardia cycle length. RESULTS: RVOP was sufficient to confirm the transition zone within the first 9 beats in the majority of SVTs. Atrial perturbation (acceleration, delayed) in the transition zone was detected in all patients with orthodromic atrioventricular (AV) reentry. Patients with typical AV nodal reentry, atypical AV nodal reentry and atrial tachycardia did not show atrial timing perturbation during fusion complexes of RVOP. CONCLUSIONS: Synchronized RVOP from RVIT or RVOT is an easy and accurate method for the quick and reliable differential diagnosis of SVT in various clinical settings, particularly when only a limited number of catheters are used.

Predictive factors of proximal advanced neoplasia in the large bowel.

INTRODUCTION: The aim of the study was to evaluate the impact of sex, age, family history and distal findings on the risk of proximal advanced neoplasia (cancer or advanced adenoma) in the large bowel. MATERIAL AND METHODS: Records for 10 111 asymptomatic participants of the Colonoscopy Screening Program (CSP), recruited from the Warsaw region between 2000 and 2004, were analyzed. A multivariate logistic regression model was used to estimate the impact of sex, age, family history and most advanced distal lesions on the occurrence of proximal advanced neoplasia. To enhance comparability of the study two definitions of the proximal colon were applied - either the splenic flexure (1(st)) or the bend between the descending and sigmoid colon (2(nd) definition) represented the boundary. RESULTS: One hundred and thirty-three (1(st)) and 167 patients (2(nd) definition) were found to have at least one advanced neoplastic lesion in the proximal part, respectively. Eleven and 14 patients were found to have carcinoma, while in 130 and 163 patients at least one proximal advanced adenoma appeared. Men were at twice as high risk of having advanced neoplasia in the proximal colon than women (OR = 1.94, 95% CI: 1.31-2.87, p = 0.001 or OR = 1.69, 95% CI: 1.20-2.40, p = 0.003, respectively). The presence of distal advanced neoplastic lesions was associated with 3.5 times higher risk of proximal advanced neoplasia (OR = 3.58, 95% CI: 2.00-6.43, p < 0.0001 or OR = 3.41, 95% CI: 1.95-5.96, p < 0.0001), respectively. CONCLUSIONS: The results may confirm some limitation of flexible sigmoidoscopy in the screening settings in comparison with colonoscopy, at least in men and people with distal advanced neoplasia.

The effect of primary care physician counseling on participation rate and use of sedation in colonoscopy-based colorectal cancer screening program--a randomized controlled study.

OBJECTIVES: Physician recommendation is a strong predictor of colorectal cancer (CRC) screening adherence, but there are no sufficient data specific to primary colonoscopy screening programs. The primary objective was to compare the effect of primary care physician's (PCP) counseling with information leaflet about CRC screening on participation rate in opportunistic primary colonoscopy screening program. Secondary objective was to determine the impact of this counseling on a decision to choose unsedated colonoscopy. MATERIAL AND METHODS: Six hundred consecutive subjects 50-65 years of age visiting PCP group practice for routine medical consultation were randomly assigned in a 1:1 ratio either to discuss CRC screening with PCP or to receive an information leaflet on CRC screening only. The outcome measures were the participation rate and the proportion of unsedated colonoscopies assessed on subjects' self-reports collected six months after the intervention. Multivariate logistic regression model with backward selection was used to investigate the association between independent covariates and binary endpoints. RESULTS: Participation rate was 47.0% (141 subjects) in the counseling group and 13.7% (41 patients) in the information leaflet group. The rates of unsedated colonoscopies were 77.0% and 39.0%, respectively. In a multivariate analyses, PCP's counseling was associated with higher participation in CRC screening (adjusted odds ratio [OR] 5.33, 95% confidence intervals [95% CI] 3.55-8.00) and higher rate of unsedated colonoscopies (OR 7.75, 95% CI 2.94-20.45). CONCLUSION: In opportunistic primary colonoscopy screening, PCP's counseling significantly increases participation rate and decreases demand for sedation compared to recruitment with information materials only. NCT01688817.

Rising hospitalization rates for inflammatory bowel disease in Poland.

INTRODUCTION: The incidence and prevalence of inflammatory bowel disease (IBD) in Poland is unknown. OBJECTIVES: We aimed to define the rates of hospitalization for IBD and time trends in the past 2 decades. PATIENTS AND METHODS: Data were obtained from the database of the National Institute of Public Health (1991-1996 and 2003-2007). Data on hospitalizations for Crohn's disease (CD) and ulcerative colitis (UC) were extracted. Age-, sex-, and disease­specific rates of hospitalization per 100,000 population were calculated. RESULTS: During the years 1991-1996 and 2003-2007, the rate of hospitalization for IBD increased each year, rising from 12.50 to 30.61 per 100,000 population. Rising time trends were observed in both sexes. The hospitalization rate increased from 3.53 to 9.35 per 100,000 population for CD and from 8.97 to 21.26 per 100,000 population for UC. A rising time trend was observed in hospitalizations for CD in men aged from 0 to 39 years. A rising time trend for CD in women was observed between the years 2003 and 2007. The hospitalization rate for UC was higher in men (9.18 to 23.29 per 100,000) than in women (8.77 to 19.37 per 100,000). Rising time trends for UC were observed in the years from 2003 to 2007 in all men and women except for those aged from 40 to 64 years. CONCLUSIONS: Hospitalization rates for IBD in Poland increased from 1991 to 1996 and from 2003 to 2007, with rising time trends in both sexes. For CD, the rising time trend in men was limited to younger age groups. The hospitalization rate for UC was significantly higher in men than in women.

A score to estimate the likelihood of detecting advanced colorectal neoplasia at colonoscopy.

OBJECTIVE: This study aimed to develop and validate a model to estimate the likelihood of detecting advanced colorectal neoplasia in Caucasian patients. DESIGN: We performed a cross-sectional analysis of database records for 40-year-old to 66-year-old patients who entered a national primary colonoscopy-based screening programme for colorectal cancer in 73 centres in Poland in the year 2007. We used multivariate logistic regression to investigate the associations between clinical variables and the presence of advanced neoplasia in a randomly selected test set, and confirmed the associations in a validation set. We used model coefficients to develop a risk score for detection of advanced colorectal neoplasia. RESULTS: Advanced colorectal neoplasia was detected in 2544 of the 35,918 included participants (7.1%). In the test set, a logistic-regression model showed that independent risk factors for advanced colorectal neoplasia were: age, sex, family history of colorectal cancer, cigarette smoking (p<0.001 for these four factors), and Body Mass Index (p=0.033). In the validation set, the model was well calibrated (ratio of expected to observed risk of advanced neoplasia: 1.00 (95% CI 0.95 to 1.06)) and had moderate discriminatory power (c-statistic 0.62). We developed a score that estimated the likelihood of detecting advanced neoplasia in the validation set, from 1.32% for patients scoring 0, to 19.12% for patients scoring 7-8. CONCLUSIONS: Developed and internally validated score consisting of simple clinical factors successfully estimates the likelihood of detecting advanced colorectal neoplasia in asymptomatic Caucasian patients. Once externally validated, it may be useful for counselling or designing primary prevention studies.

Chronic low-dose aspirin use does not alter colonic mucosa in asymptomatic individuals: a prospective cross-sectional study (STROBE 1a).

OBJECTIVES: Aspirin may be involved in microscopic colitis (MC) development, but there are no data on colon histology in asymptomatic aspirin users. We prospectively assessed colonic and rectal mucosa from aspirin users, searching for MC features. METHODS: From colonoscopy screenees, two biopsy samples were taken from each of three locations: ascending colon, transverse colon and rectum. A pathologist measured chronicity of inflammation and activity indicators, epithelial cell height and subepithelial collagen layer width. Intraepithelial lymphocytes (IELs), intralaminal eosinophils and apoptotic cells/100 crypts were counted. Panel data models were used to analyse associations between aspirin use, biopsy location and microscopic parameters. RESULTS: Of 100 screenees (age: 40-65 years), 42 were current aspirin users. Median duration of aspirin usage was 48 months (range: 36-60) with dosage ranging from 75-325 mg/day. We observed reduced epithelium polymorphs in subjects who used aspirin for <48 months versus non-users (p=0.008). Paneth cell metaplasia was significantly less frequent in aspirin users versus non-users (p=0.006). Inflammatory cells in lamina propria (eosinophils) and epithelium (IELs) were most abundant in the ascending colon and decreased distally (ascending colon vs transverse colon and transverse colon vs rectum). Cryptitis was more frequent in the ascending colon vs the rectum. CONCLUSIONS: We observed no specific MC features in asymptomatic chronic low-dose aspirin users. We found subtle physiological and histopathological differences between the bowel segments.

Cyclooxygenase-2 immunohistochemical expression in serrated polyps of the colon.

AIM OF THE STUDY: Cyclooxygenase-2 (COX-2) expression has been observed in a substantial percentage of classical adenomas of the large bowel. The aim of the study was to assess and compare the expression of COX-2 in serrated polyps of the colon. MATERIAL AND METHODS: One hundred and nineteen serrated polyps were analyzed. There were 83 hyperplastic polyps (HP), 19 sessile serrated polyps (SSP) and 17 traditional serrated adenomas (TSA). COX-2 expression was assessed semi-quantitatively (0-2) and each lesion was fully characterized in terms of anatomical location, size, histology, age and sex of the patient. The general estimating equation (GEE) model with logit link was used in the statistical analysis. RESULTS: Epithelial expression of COX-2 was found in 85/119 serrated polyps (71.43%): 57/83 (68.67%) HP, 16/19 (84.21%) SSP, and 12/17 (70.59%) TSA. In HP and SSP it was predominantly of weak (49/83 HP, 12/19 SSP), whereas in TSA it was mainly of medium/strong intensity (8/17). The TSA category was associated with more frequent COX-2 expression (OR = 7.00, 95% CI: 1.49-32.88, p = 0.014) than HP, but such relation was not found for SSP vs. HP (p > 0.1). No associations between COX-2 expression and clinical parameters were found. CONCLUSIONS: Immunohistochemical COX-2 expression cannot serve as a diagnostic adjunct to differentiate HP and SSP.

Detection of anti-SP100 antibodies in primary biliary cirrhosis. Comparison of ELISA and immunofluorescence.

Primary biliary cirrhosis (PBC) is, which a chronic, autoimmune liver disease. Some patients have antinuclear antibodies anti-Sp100, which are considered to be disease-specific. We compared an enzyme-linked immunosorbent assay (ELISA) and indirect immunofluorescence (IIF) for detection of anti-Sp100. The sensitivity of anti-Sp100 determined by ELISA and IIF was 44% and 34%, respectively. Specificity was 99% for ELISA and 98% for IIF, respectively. The positive and negative predictive value (PPV, NPV) for anti-Sp100 determined by ELISA were 98%, 60% and 95%, 56% for IIF respectively. IIF required substantial experience in interpreting subjective patterns, whereas ELISA was more sensitive, cheaper, less time consuming, and produced clear-cut quantitative results.

Small bowel tumors detected and missed during capsule endoscopy: single center experience.

AIM: To characterize small bowel (SB) tumors detected by capsule endoscopy (CE), and identify missed tumors. METHODS: The study included 145 consecutive patients in whom 150 CEs were performed. Following CE, the medical records of the study population were reviewed. Results of double- or single-balloon enteroscopy performed after CE and the results of surgery in all patients operated on were retrieved. The patients were contacted through telephone interviews or postal mail. In addition, the national cancer registry and the polish clinical gastrointestinal stromal tumor (GIST) Registry were searched to identify missed neoplasms. RESULTS: Indications for CE included overt and occult obscure gastrointestinal bleeding (n = 81, 53.7%), anemia (n = 19, 12.7%), malabsorption (n = 18, 12%), abnormal CB follow through (n = 9, 6%), abdominal pain (n = 7, 5%), celiac disease (n = 5, 3%), neuroendocrine tumor (n = 3, 2%), Crohn's disease (n = 2, < 2%), Peutz-Jeghers syndrome (n = 2, < 2%), other polyposes (n = 2, < 2%), and diarrhea (n = 2, < 2%). The capsule reached the colon in 115 (76.6%) examinations. In 150 investigations, CE identified 15 SB tumors (10%), 14 of which were operated on or treated endoscopically. Malignancies included metastatic melanoma (n = 1), adenocarcinoma (n = 2), and GIST (n = 3). Benign neoplasms included dysplastic Peutz-Jeghers polyps (n = 4). Non-neoplastic masses included venous malformation (n = 1), inflammatory tumors (n = 2), and a mass of unknown histology (n = 1). During the follow-up period, three additional SB tumors were found (2 GISTs and one mesenteric tumor of undefined nature). The National Cancer Registry and Polish Clinical GIST Registry revealed no additional SB neoplasms in the post-examination period (follow-up: range 4.2-102.5 mo, median 39 mo). The sensitivity of CE for tumor detection was 83.3%, and the negative predictive value was 97.6%. The specificity and positive predictive value were both 100%. CONCLUSION: Neoplasms may be missed by CE, especially in the proximal SB. In overt obscure gastrointestinal bleeding, complementary endoscopic and/or radiologic diagnostic tests are indicated.

Proximal shift of advanced adenomas in the large bowel--does it really exist?

INTRODUCTION: During the last decades, the proximal shift in the distribution of colorectal carcinomas (CRCs) has been described. It is uncertain whether the shift is the result of actual changes in CRC incidence or reflects population aging. Most CRCs develop as a result of malignant progression of benign epithelial neoplasms--advanced adenomas (AA). OBJECTIVES: The aim of the study was to investigate whether the proximal shift of AA occurs over time. PATIENTS AND METHODS: Two databases were used. The first one (RETRO) included consecutive patients of the Department of Gastroenterology treated between the years 1981 and 1994. The secondone (Colonoscopy Screening Program--CSP) included asymptomatic participants of the colonoscopy screening program recruited between 2000 and 2004 from the Warsaw region. Only patients with AA who underwent total colonoscopy were included in the analysis. AA was defined as adenoma of 10 mm or more in diameter, with high-grade neoplasia, and villous or tubulovillous morphology, or any combination of the above features. The analysis was conducted using 2 different definitions of the proximal segment in the large intestine--either splenic flexure or the bend between the descending and sigmoid colon. To compare the distribution of AA, a multiple logistic regression model was used. RESULTS: 41 of 200 patients (20.5%) in RETRO and 122 of 430 patients (28.4%) in CSP group, respectively, were found to have AA located proximally to the splenic flexure. No proximal shift of AA was found after age and sex adjustment (P>0.1). CONCLUSIONS: The risk of having proximal AA was similar in both groups. The results suggest the lack of proximal shift in the distribution of advanced colorectal adenomas.

Randomized comparison of three palliative regimens including brachytherapy, photodynamic therapy, and APC in patients with malignant dysphagia (CONSORT 1a) (Revised II).

OBJECTIVES: Because most esophageal cancers are diagnosed at an advanced stage, a majority of patients require palliative dysphagia treatment. Dysphagia severity and the need for repeated re-canalization procedures significantly affect patients' quality of life (QoL). The aim of this study was to establish whether combining argon plasma coagulation (APC) of the neoplastic esophageal tissue with another re-canalization method results in a longer dysphagia-free period compared with APC alone. METHODS: We conducted a randomized trial in 93 patients with malignant dysphagia. Patients were followed until death. We compared three regimens of esophageal re-canalization; APC combined with high dose rate (HDR) brachytherapy, APC combined with photodynamic therapy (PDT), and APC alone. The primary outcome measure was the dysphagia-free period following randomization. Secondary measures were survival, QoL, treatment-associated complications, and treatment tolerance. A per-protocol analysis was carried out. RESULTS: The time to first dysphagia recurrence was significantly different between each combination treatment group and the control group (overall test: P=0.006; HDR vs. control, log-rank P=0.002, PDT vs. control, log-rank P=0.036), but not different between the combination groups (HDR vs. PDT, log-rank P=0.36). The median time to first dysphagia recurrence was 88, 59, and 35 days in the HDR, PDT, and control groups, respectively. There was no difference in overall survival between the study groups (P=0.27). No deaths, perforations, hemorrhages, or fistula formations were attributed to treatment. The only major complication was fever, occurring in three PDT patients. Minor complications were observed significantly more often in the combination treatment groups and included pain in both groups, transient dysphagia worsening, and skin sensitivity in the PDT group. The QoL 30 days after treatment in the HDR group was significantly better than in the other groups. CONCLUSIONS: In patients with inoperable esophageal cancer, palliative combination treatment of dysphagia with APC and HDR or PDT was significantly more efficient than APC alone, and was safe and well tolerated. APC combined with HDR resulted in fewer complications and better QoL than APC with PDT or APC alone (CONSORT 1b).

Quality indicators for colonoscopy and the risk of interval cancer.

BACKGROUND: Although rates of detection of adenomatous lesions (tumors or polyps) and cecal intubation are recommended for use as quality indicators for screening colonoscopy, these measurements have not been validated, and their importance remains uncertain. METHODS: We used a multivariate Cox proportional-hazards regression model to evaluate the influence of quality indicators for colonoscopy on the risk of interval cancer. Data were collected from 186 endoscopists who were involved in a colonoscopy-based colorectal-cancer screening program involving 45,026 subjects. Interval cancer was defined as colorectal adenocarcinoma that was diagnosed between the time of screening colonoscopy and the scheduled time of surveillance colonoscopy. We derived data on quality indicators for colonoscopy from the screening program's database and data on interval cancers from cancer registries. The primary aim of the study was to assess the association between quality indicators for colonoscopy and the risk of interval cancer. RESULTS: A total of 42 interval colorectal cancers were identified during a period of 188,788 person-years. The endoscopist's rate of detection of adenomas was significantly associated with the risk of interval colorectal cancer (P=0.008), whereas the rate of cecal intubation was not significantly associated with this risk (P=0.50). The hazard ratios for adenoma detection rates of less than 11.0%, 11.0 to 14.9%, and 15.0 to 19.9%, as compared with a rate of 20.0% or higher, were 10.94 (95% confidence interval [CI], 1.37 to 87.01), 10.75 (95% CI, 1.36 to 85.06), and 12.50 (95% CI, 1.51 to 103.43), respectively (P=0.02 for all comparisons). CONCLUSIONS: The adenoma detection rate is an independent predictor of the risk of interval colorectal cancer after screening colonoscopy.

Leiomyosarcoma of the inferior vena cava: clinicopathologic study of 40 cases.

This report details the clinicopathologic features and follow-up data on 40 cases of inferior vena cava leiomyosarcoma, a rare sarcoma with a poor prognosis. Study cohort consisted of 31 females and 9 males (mean age, 53 y), whose material was accessioned to the Armed Forces Institute of Pathology between 1976 and 2008. Inferior vena cava leiomyosarcomas ranged in size from 3.5 to 15.0 (median, 8.5) cms, and most involved the middle segment of the vessel and grew extraluminally. Eleven leiomyosarcomas were French Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) histologic grade I; 21, grade II; and 5 were grade III. Eleven of 33 patients managed by complete or radical resection had involved surgical margins. Twenty of the 34 patients (59%) with clinical follow-up data (mean, 33.5; median, 51 mo) died of sarcoma-related complications and 9 (26%) of unknown causes. The 5-year and 10-year survival rates after resection without documented residual macroscopic disease were 50% and 22%, respectively. Two patients are alive without disease 9 and 18 years after last surgical intervention. Suprahepatic vena caval and right atrial involvement by tumor, predominant intraluminal tumor growth, and residual postsurgical macroscopic disease were factors that statistically correlate with death within 2 years. By univariate analysis, intraluminal tumor (P=0.03), liver injury or failure (compromised liver) (P=0.01), and moderate to poor tumor differentiation (P=0.03) were associated with increased tumor-related mortality, whereas a compromised liver (P=0.01) was the only factor correlated with mortality by multivariate analysis. Our study concludes that a macroscopic resection of localized inferior vena cava leiomyosarcoma provides the best chance for long-term survival, suprahepatic tumors often result in early death, and a compromised liver correlates with overall poor survival, but French Federation Nationale des Centres de Lutte Contre le Cancer grading does not affect prognosis.

Aging or comorbid conditions - what is the main cause of kidney damage?

BACKGROUND: Chronic kidney disease (CKD) is widespread in the general population. It is generally accepted that worsening renal function is common with aging. However, the question still remains whether it is caused by the natural process of aging or whether coexisting chronic diseases and comorbid conditions contribute to deteriorating renal function. METHODS: The frequency of albuminuria-the marker of early kidney damage-was evaluated according to different coexisting conditions in younger (18/64 years old, n=2,074) and elderly (=65 years old, n=395) participants of the Polish study PolNef on early detection of CKD. Multivariate logistic regression was performed to identify associations between elevated levels of albuminuria, age and coexisting conditions. RESULTS: 12% of the younger group demonstrated albuminuria compared to 18% of the elderly. Independent predictors of detecting an elevated level of albuminuria for the whole examined population were male gender (2.48, 1.59-3.88), hypertension ineffectively treated (1.8, 1.34-2.4), diabetes (1.67, 1.11-2.49), and age (1.56, 0.97-2.52) at border levels of significance. Moreover, elevated levels of albuminuria occurred more frequently in the obese elderly group (1.89, 0.98-3.63, p=0.058). The following predictors were found based on gender: for men, hypertension regardless of efficacy of treatment, diabetes, smoking, and age at border level of significance, in contrast to women who had the sole predictor of ineffectively treated hypertension. CONCLUSIONS: The influence of aging alone on kidney damage is not evident. Moreover, it is different in males and females. Hypertension is the only coexisting comorbid condition contributing to kidney damage in both males and females. Advanced age together with comorbid conditions is more harmful to the kidney in males.

CHOP-21 for unfavorable Hodgkin's lymphoma. An exploratory study.

ABVD remains a standard chemotherapy for Hodgkin Lymphoma (HL) despite many efforts to demonstrate the superiority of other regimens. Bleomycin was proven marginally active in this combination (J Clin Oncol 22:1532-3, 2004) but adding significant toxicity. Response to ABVD is often slow and relapse rate of 20-30% is a concern. ABVD has never been directly compared to CHOP, the other global standard for other lymphomas that is composed of agents certainly active in HL. Current study is an update on our initial report of 2004 (Blood 104, 2004). In addition to extending the follow-up, we compared outcome after CHOP in a pilot series of previously untreated patients with a retrospective results of ABVD therapy at our institution. CR/CRu rates were 88 and 62% for CHOP and ABVD, respectively. In CHOP CS III/IV group, more patients had at least three risk factors (80%) than in ABVD CS III-IV group (40%). In contrast to ABVD, there were no deaths in CHOP group, but EFS was inferior. This might result from a higher risk level in CHOP patients. Toxicity of both regimens was mild: grade 3/4 leukopenia in 9%, grade 1/2/3 peripheral neuropathy in 6% of ABVD patients, and grade 3/4 neutropenia in 7% of CHOP patients. In conclusion, CHOP-21 is an active and low-toxic regimen in HL with risk factors. A prospective comparison of CHOP with a standard chemotherapy in a randomized study will be justified.