Stepan Suchanek

A large randomised controlled intervention trial to prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: baseline results and factors affecting the eradication

Objective To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China. Design A total of 184 786 residents aged 25–54 years were enrolled in this trial and received 13C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth. Results The prevalence of H. pylori in trial participants was 57.6%. A total of 94 101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baseline-value of 13C-urea breath test, missed medication doses, smoking and drinking were independent predictors of eradication failure. The missed doses and high baseline delta over baseline-value were important contributors in men and women (all Ptrend<0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend<0.001), while high body mass index (Ptrend<0.001) and history of stomach disease were significant predictors in women. The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined. Conclusions This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies. Trial registration number ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.

Colorectal cancer screening: 20 years of development and recent progress

Colorectal cancer (CRC) is the second most common cancer in Europe and its incidence is steadily increasing. This trend could be reversed through timely secondary prevention (screening). In the last twenty years, CRC screening programs across Europe have experienced considerable improvements (fecal occult blood testing; transition from opportunistic to population based program settings). The Czech Republic is a typical example of a country with a long history of nationwide CRC screening programs in the face of very high CRC incidence and mortality rates. Each year, approximately 8000 people are diagnosed with CRC and some 4000 die from this malignancy. Twenty years ago, the first pilot studies on CRC screening led to the introduction of the opportunistic Czech National Colorectal Cancer Screening Program in 2000. Originally, this program was based on the guaiac fecal occult blood test (FOBT) offered by general practitioners, followed by colonoscopy in cases of FOBT positivity. The program has continuously evolved, namely with the implementation of immunochemical FOBTs and screening colonoscopy, as well as the involvement of gynecologists. Since the establishment of the Czech CRC Screening Registry in 2006, 2405850 FOBTs have been performed and 104565 preventive colonoscopies recorded within the screening program. The overall program expanded to cover 25.0% of the target population by 2011. However, stagnation in the annual number of performed FOBTs lately has led to switching to the option of a population-based program with personal invitation, which is currently being prepared.

Reporting systems in gastrointestinal endoscopy: Requirements and standards facilitating quality improvement: European society of gastrointestinal endoscopy position statement

To develop standards for high quality of gastrointestinal endoscopy, the European Society of Gastrointestinal Endoscopy (ESGE) has established the ESGE Quality Improvement Committee. A prerequisite for quality assurance and improvement for all gastrointestinal endoscopy procedures is state-of-the-art integrated digital reporting systems for standardized documentation of the procedures. The current paper describes the ESGE’s viewpoints on requirements for high-quality endoscopy reporting systems. The following recommendations are issued: Endoscopy reporting systems must be electronic. Endoscopy reporting systems should be integrated into hospital patient record systems. Endoscopy reporting systems should include patient identifiers to facilitate data linkage to other data sources. Endoscopy reporting systems shall restrict the use of free text entry to a minimum, and be based mainly on structured data entry. Separate entry of data for quality or research purposes is discouraged. Automatic data transfer for quality and research purposes must be facilitated. Double entry of data by the endoscopist or associate personnel is discouraged. Available data from outside sources (administrative or medical) must be made available automatically. Endoscopy reporting systems shall enable the inclusion of information on histopathology of detected lesions; patient’s satisfaction; adverse events; surveillance recommendations. Endoscopy reporting systems must facilitate easy data retrieval at any time in a universally compatible format. Endoscopy reporting systems must include data fields for key performance indicators as defined by quality improvement committees. Endoscopy reporting systems must facilitate changes in indicators and data entry fields as required by professional organizations.

Training on an ex vivo animal model improves endoscopic skills: a randomized, single-blind study

BACKGROUND Animal models are used for training of different endoscopic procedures. Whether this really improves endoscopic skills remains controversial. OBJECTIVE To assess the effectiveness of training by using an ex vivo animal gastric model on the performance of two therapeutic procedures-hemostasis and treatment of perforation. DESIGN A randomized, single-blind study. SETTING An experimental endoscopy center in a university hospital. PARTICIPANTS Thirty-one gastroenterology fellows with comparable endoscopic experience. METHODS Participants were randomized into two groups: with (T, n = 16) and without (S, n = 15) training. All fellows continued with standard endoscopic practice. Baseline skills were assessed at enrollment. All physicians in group T underwent 2 full days of a hands-on course over a 3-month period, in addition to their standard endoscopic practice. Both groups then underwent a blinded, final evaluation. Endoscopic skills were scored from 1 (best) to 5 (poorest) by two expert, blinded tutors. Outcomes of clinical hemostatic procedures also were analyzed. MAIN OUTCOME MEASUREMENTS Successful hemostasis and successful perforation closure. RESULTS Thirty physicians completed the study. Hemostasis results (n = 15): The number of physicians who carried out a successful hemostasis procedure increased significantly in the group with training (27% vs 73%; P = .009) but did not change in the group without training (20% vs 20%). The mean scores of injection and clipping technique improved significantly only after training. The number of clips used decreased significantly only in the group with training; the time of clipping did not change significantly in either group. Perforation results (n = 15): The number of physicians with a successful and complete perforation closure increased nearly significantly in the group with training (40% vs 73%, P = .06) as opposed to the group without training (27% vs 47%; P = .27). The procedure time decreased significantly in the group with training only. In clinical practice, fellows in group T had a significantly higher success rate with respect to hemostatic procedures (83.2%, range 67-100 vs 63.6%, range 25-100; P = .0447). The majority of participants (93%) agreed that such courses should be compulsory in gastroenterological credentials. LIMITATIONS A retrospective analysis of clinical outcomes. Clinical outcome data were based on self-reporting of the participants. CONCLUSION Hands-on training by using an animal ex vivo model improves endoscopic skills in both hemostasis and perforation closure. In clinical practice, the training improves the outcome of hemostatic procedures.

Colorectal cancer prevention in the Czech Republic: time trends in performance indicators and current situation after 10 years of screening

The incidence and mortality of colorectal cancer (CRC) in the Czech Republic is significant. The National CRC Screening Program started in 2000 and was further enhanced in 2009. In 2010, the European Guidelines were introduced. The aim of the present trend study was to evaluate the quality of the Czech National Colorectal Cancer Screening Program using early performance and long-term impact indicators. The screening program has been assessed using data from three sources: the Czech National Cancer Registry, the Czech National Reference Centre, and the Czech CRC Screening Registry. The data were compared with a set of recommended quality control indicators. Between 2006 and 2010, a total of 1 881 299 fecal occult blood tests were performed, of which 87 397 were positive (4.6%). Until 2011, a total of 68 527 fecal occult blood test follow-up colonoscopies were performed. In addition, between 2009 and 2011, a total of 10 309 screening colonoscopies were performed. As a result, a total of 25 255 adenomas (32.0% rate) and 3379 CRCs (4.3% rate) were detected. A trend of cancer detection in earlier stages has been observed. The overall program coverage has increased to 22.7% of the target population in 2010. The majority of European guidelines’ quality indicators for nonpopulation-based programs were implemented in the Czech National CRC Screening program. An improvement in program management was accompanied by an increase in coverage as well as other performance indicators.

Improvements in colorectal cancer screening programmes – quantitative immunochemical faecal occult blood testing – how to set the cut-off for a particular population

OBJECTIVE The aim of the study was to determine the optimum cut-off value of the quantitative immunochemical test (q-FIT) OC-Sensor for colorectal cancer and advanced adenomatous polyps in a particular population. METHODS 815 patients were referred for colonoscopy and were offered two q-FIT examinations at two different colonoscopy centers. The patients were classified according to the colonoscopic findings. Test sensitivity, specificity, and accuracy were statistically evaluated using one test and two tests at the levels of 50, 75, 100, 125, and 150 ng/mL of faecal hemoglobin in those patients with advanced polyps and colorectal cancer. The optimum cut-off test level for clinically significant neoplasia was determined using one test. RESULTS The optimum cut-off value of q-FIT OC-Sensor for the detection of clinically significant neoplasia in our particular population was determined as 75 ng/mL using one test. This value provides an optimum proportion of 73% sensitivity (±95% CI 60.3% - 83.4%) and 90% specificity (±95% CI 86.8% - 92.8%), PPV and NPV were determined as 54.76% and 95.43% respectively. CONCLUSIONS The first step in the implementation of q-FIT test in the screening program in our country is to determine the optimum cut-off level for a population, and to estimate the number of tests performed with respect to the optimum cost effectiveness and economical climate. Using one test, the optimum level of q-FIT OC-Sensor® in the Czech Republic was determined as 75 ng/mL. This study could serve as a model for further studies in other countries, where screening does not yet exist.

How significant is the association between metabolic syndrome and prevalence of colorectal neoplasia

The incidence and prevalence of metabolic syndrome (MS) and colorectal cancer (CRC) has been rising in developed countries. The association between these two diseases has been widely studied and reported. Less evidence is available about the relationship between MS and CRC precancerous lesions (adenomatous polyps, adenomas). The aim of this paper is to present an overview of our scientific understanding of that topic and its implication in clinical practice. One of the principal goals of current CRC secondary prevention efforts is to detect and remove the precancerous lesions in individuals with an average CRC risk to prevent the development of invasive cancer. MS is not currently considered a high-risk CRC factor and is therefore not included in the guidelines of organized screening programs. However, in light of growing scientific evidence, the approach to patients with MS should be changed. Metabolic risk factors for the development of adenomas and cancers are the same - obesity, impaired glucose tolerance, dyslipidemia, hypertension, cardiovascular diseases and diabetes mellitus type 2. Therefore, the key issue in the near future is the development of a simple scoring system, easy to use in clinical practice, which would identify individuals with high metabolic risk of colorectal neoplasia and would be used for individual CRC secondary prevention strategies. Currently, such scoring systems have been published based on Asian (Asia-Pacific Colorectal Screening Score; APCS) and Polish populations.

Monitoring of Circulating Tumor Cells by a Combination of Immunomagnetic Enrichment and RT-PCR in Colorectal Cancer Patients Undergoing Surgery

BACKGROUND The presence of circulating tumor cells (CTC) has been reported in patients with advanced colorectal cancer. Monitoring CTC (also known as a liquid-biopsy) has recently become the center of interest for low-invasive monitoring of cancer progression and predictive biomarkers testing. Along with high-cost technology and a complex methodology, a straightforward method based on magnetic beads enrichment followed by RT-PCR is set to allow for routine CTC analysis in colorectal cancer patients. OBJECTIVES The main purpose of this study was to evaluate the possibility of CTC detection in routine monitoring of patients starting before and continuing after surgery. MATERIAL AND METHODS The investigated group consisted of 30 patients mainly in advanced stages of colorectal cancer. In all patients, CTC detection was performed prior to surgery, in a subset of 14 patients additional sampling was done during and after surgery. In all cases, peripheral blood was processed using AdnaTest ColonCancer kit, which relies on enriching CTCs using EpCAM-functionalized magnetic beads and subsequently identifying tumorspecific CEA, EGFR and GA733-2 mRNA transcripts. RESULTS Out of all the tested samples, CTC were found in one patient suffering from advanced disease with lung and liver metastases. There, however, the positive finding was confirmed in 3 consecutive samples acquired before, during and shortly after palliative R2 resection. CONCLUSIONS The presence of CTC may be used to observe post-operative disease development. Due to the overall low CTC detection, further technology development may be necessary before its universal applicability to manage colorectal cancer patients.

Improved specimen adequacy using jumbo biopsy forceps in patients with Barrett's esophagus.

AIM To assess the sampling quality of four different forceps (three large capacity and one jumbo) in patients with Barretts esophagus. METHODS This was a prospective, single-blind study. A total of 37 patients with Barretts esophagus were enrolled. Targeted or random biopsies with all four forceps were obtained from each patient using a diagnostic endoscope during a single endoscopy. The following forceps were tested: A: FB-220K disposable large capacity; B: BI01-D3-23 reusable large capacity; C: GBF-02-23-180 disposable large capacity; and jumbo: disposable Radial Jaw 4 jumbo. The primary outcome measurement was specimen adequacy, defined as a well-oriented biopsy sample 2 mm or greater with the presence of muscularis mucosa. RESULTS A total of 436 biopsy samples were analyzed. We found a significantly higher proportion of adequate biopsy samples with jumbo forceps (71%) (P < 0.001 vs forceps A: 26%, forceps B: 17%, and forceps C: 18%). Biopsies with jumbo forceps had the largest diameter (median 2.4 mm) (P < 0.001 vs forceps A: 2 mm, forceps B: 1.6 mm, and forceps C: 2mm). There was a trend for higher diagnostic yield per biopsy with jumbo forceps (forceps A: 0.20, forceps B: 0.22, forceps C: 0.27, and jumbo: 0.28). No complications related to specimen sampling were observed with any of the four tested forceps. CONCLUSION Jumbo biopsy forceps, when used with a diagnostic endoscope, provide more adequate specimens as compared to large-capacity forceps in patients with Barretts esophagus.

Cut-off optimization for 13 C-urea breath test in a community-based trial by mathematic, histology and serology approach

The performance of diagnostic tests in intervention trials of Helicobacter pylori (H.pylori) eradication is crucial, since even minor inaccuracies can have major impact. To determine the cut-off point for 13C-urea breath test (13C-UBT) and to assess if it can be further optimized by serologic testing, mathematic modeling, histopathology and serologic validation were applied. A finite mixture model (FMM) was developed in 21,857 subjects, and an independent validation by modified Giemsa staining was conducted in 300 selected subjects. H.pylori status was determined using recomLine H.pylori assay in 2,113 subjects with a borderline 13C-UBT results. The delta over baseline-value (DOB) of 3.8 was an optimal cut-off point by a FMM in modelling dataset, which was further validated as the most appropriate cut-off point by Giemsa staining (sensitivity = 94.53%, specificity = 92.93%). In the borderline population, 1,468 subjects were determined as H.pylori positive by recomLine (69.5%). A significant correlation between the number of positive H.pylori serum responses and DOB value was found (rs = 0.217, P < 0.001). A mathematical approach such as FMM might be an alternative measure in optimizing the cut-off point for 13C-UBT in community-based studies, and a second method to determine H.pylori status for subjects with borderline value of 13C-UBT was necessary and recommended.