Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country. METHODOLOGY: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus. RECOMMENDATIONS: We present here the second part of the Society's recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure. CONCLUSIONS: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania.

Position paper on treatment of hepatitis C in Romania, 2017. Part one.

BACKGROUND AND AIMS: Hepatitis C Virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania the mean prevalence is about 3%. New treatments became available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country. METHODOLOGY: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention has been created. These items were discussed and rated. Decisions were taken by consensus. RECOMMENDATIONS: We present here the first of the two parts of our Society's recommendations for chronic HCV infection treatment. An agreement was reached regarding the diagnostic tools, the assessment of severity and the up-dated therapy schedules. CONCLUSIONS: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to the real-life conditions in this country.

The role of narrow band imaging in colorectal polyp detection.

Colonoscopic detection and removal of polyps represent the most important prevention method for colorectal cancer. We aimed to investigate the diagnostic yield of narrow band imaging (NBI) colonoscopy for polyp detection compared with standard colonoscopy. In this prospective study, 505 patients that underwent total colonoscopy were randomized into two groups: 226 patients in NBI group and 279 in non-NBI group (standard colonoscopy). The primary endpoints were polyp detection rate (PDR) and adenoma detection rate (ADR) in both groups. Polyps detected with NBI technique were characterized according to the NBI International Colorectal Endoscopic (NICE) classification. The total number of polyps detected in NBI group was significantly higher compared with non-NBI group (325 polyps in 226 patients versus 189 polyps in 279 patients, respectively). PDR in NBI group was 55.3%, versus 43.3% in non-NBI group. ADR in NBI group was significantly higher compared with non-NBI group (35.3% versus 20%, respectively). The proportion of detected adenomas in the left-sided colon was significantly higher in NBI group (72.8% versus 61.06% in non-NBI group), which was related to an increased number of small adenomas detected in NBI group. Also, in NBI group, a significant number of flat adenomas were detected (28 versus 9 in non-NBI group). A total of 147 (45.2%) polyps were classified according to the NICE classification, and showed a good correlation with histological analysis. In conclusion, this study demonstrated increased PDR and ADR for NBI colonoscopy. A good correlation between the NICE classification and histological analysis was also observed.

Proposed score for the self-assessment of an endoscopy department performance in colonoscopy screening.

The aim of the paper was to propose a score for performance evaluation in colonoscopy units. METHOD: We proposed a score (CDCD score - Cecal intubation, polyp Detection rate, Cleansing and Documentation of cecal intubation) based on the following parameters that assess the quality of colonoscopy units: total colonoscopies rate, polyp detection rate, rate of cecal intubation photo record, rate of recorded Boston bowel preparation scale (BBPS) (rated 1 to 5 stars). The mean score obtained based on the above mentioned criteria was used as a quality parameter of the endoscopy unit. We applied and calculated this score in all screening colonoscopies performed in our Endoscopy Department during the last 4 years. RESULTS: The study group included 856 screening colonoscopies. The rate of total colonoscopies was 92.1% (789/856 cases) and the polyp detection rate was 23.9%. Regarding the quality of bowel preparation, the BBPS was recorded in 51.1% cases. The cecal intubation was photo recorded in 44% of cases. We considered that of the 4 parameters, the highest weight for an excellent quality belonged to the cecal intubation rate, followed by the polyp detection rate, because they evaluate the endoscopic technique, while the other 2 are more administrative. Thus, for the unit's assessment we used the following equation: UNIT'S QUALITY CDCD SCORE = (3×cecal intubation rate+3×polyp detection rate+1×photo documentation+1×BBPS documentation)/8. Thus, the CDCD Score for our unit was ≈4 stars (3.7 stars). CONCLUSION: The proposed CDCD score may be an objective tool for the quality assessment in different endoscopy units.

Fecal transplantation indications in ulcerative colitis. Preliminary study.

BACKGROUND AND AIMS: Fecal microbiota transplantation is used with success in persistent (more than two episodes) Clostridium Difficile Infection; it has also gained importance and started to be used in inflammatory bowel disease. There are theoretical arguments that justify its use in ulcerative colitis or Crohn's disease. Based on our clinical cases we tried to evaluate the indications of fecal microbiota transplantation young patients with ulcerative colitis and multiple relapses, in which biological or immunosuppressive treatment were ineffective. METHODS: Five patients with moderate-severe ulcerative colitis or Clostridium Difficile infection who ceased to have a therapeutic response to biological therapy, were given fecal microbiota transplant as an alternative to biological therapy and/or immunosuppression. Fecal microbiota transplant was administered via colonoscopy using healthy donors from their family. RESULTS: The results were favorable and spectacular in all patients and complete remission was achieved for at least 10 months. Clinical remission was achieved in all patients. Endoscopic appearance of ulcers in patients improved. In 2 patients the effect of the fecal microbiota transplant diminished after 10-12 months and the tendency to relapse appeared (3-4 stools/day, blood streaks present sometimes in the stool). Reintroduction of systemic therapy or immunosuppression demonstrated that patients regained the therapeutic response to these treatments, and remission was maintained. CONCLUSION: Fecal microbiota transplantation can be used as salvage therapy in patients refractory to biological therapy, as elective therapy in clostridium difficile infection or as an alternative therapy in young patients with multiple relapses who have reservations regarding biological or immunosuppressive treatment.

Self-Administered Home Series Fecal "Minitransplants" for Recurrent Clostridium difficile Infection on a Rectal Remnant.

A fecal microbiota transplant has proved to be an extremely effective method for patients with recurrent infections with Clostridium difficile. We present the case of a 65-year-old female patient with multiple Clostridium difficile infection (CDI) relapses on the rectal remnant, post-colectomy for a CDI-related toxic megacolon. The patient also evidenced associated symptomatic Clostridium difficile vaginal infection. She was successfully treated with serial fecal "minitransplants" (self-administered at home) and metronidazole ovules.

Intra-esophageal whitish mass - a challenging diagnosis.

BACKGROUND: Whitish intraluminal esophageal masses might represent the endoscopic feature of a bezoar or a pedunculated tumor, most likely a fibrovascular polyp, without exclusion of other mesenchymal tumors (leiomyoma, lipoma, gastrointestinal stromal tumor, leiomyosarcoma, granular cell tumor). If a process of dystrophic calcification is also encountered the differential diagnosis can be a challenge even after histological analysis, as it is highlighted by our case. CASE PRESENTATION: A 65-year-old female whom took lactate calcium tablets for 5 years presented with progressive dysphagia. A whitish esophageal mass with an appearance of a pharmacobezoar was detected at esophagoscopy. A pedunculated tumor was considered in the differential diagnosis, but the imagistic studies ruled out a pedicle. This intraluminal esophageal mass highly suggestive for a pharmacobezoar was endoscopically removed. The challenge of correct diagnosis was raised by histological examination performed after immersion into trichloracetic acid for decalcification. The identification of hyaline fibrous tissue, with numerous crystalline basophils deposits of minerals, rare fibrocytes and very few vessels brought in discussion a mesenchymal originating mass, most likely a fibrovascular polyp, even the pedicle was not detected. CONCLUSION: Based on our challenging and difficult to diagnose case we proposed an uncommon evolution: auto-amputation and calcification of an esophageal mesenchymal originating tumor (most likely a fibrovascular polyp).

Increasing prevalence of right-sided colonic adenomas in a high-volume endoscopy department in Romania: implications for colorectal cancer screening.

BACKGROUND & AIMS: A gradual shift of colorectal adenoma and carcinoma location toward the proximal colon has been recently observed both in the United States and Europe. We aimed to study the polyp and adenoma detection rate in a major endoscopy center of northwestern Romania over a 16-year period, and to characterize the distribution and the pathological features of the removed polyps according to age and sex, in order to assess the trend of proximal adenoma prevalence in our population. METHODS: We retrospectively analyzed 9,230 consecutive colonoscopies performed between 1996 and 2011 in a high-volume outpatient clinic in Cluj-Napoca, Romania. We analyzed 2,436 complete colonoscopies that detected 3,642 polyps in two time periods: 1996 to 2003 and 2004 to 2011. We compared the number, size and histopathological features of the polyps removed from the right-sided colon and the left sided-colon in the two periods. RESULTS: An increasing trend of polyp detection rate in the right-sided colon was observed, from 9.36% in the first period to 12.17% in the second period (p<0.001). The prevalence of right-sided colon adenomas also presented an increased trend (OR 1.45; CI95% 1.02-2.05; p=0.03). High-grade dysplasia (HGD) was found in 8.6% of the adenomas and in 4.1% of the diminutive polyps. Advanced neoplasia was detected in 1.5% of persons younger than 50 years. Multivariate logistic regression analysis evidenced that the right-sided polyps were significantly associated with the last time period (OR 1.3; p=0.001; CI95% 1.12-1.56), male gender (OR-1.3; p=0.001; CI95% 1.1-1.5) and age above 48 years (OR 1.3; p=0.006: CI95% 1-1.6). CONCLUSION: An increasing trend of polyp detection rate in the right-sided colon was documented, with an increasing prevalence of right-sided adenomas. The evaluation of the proximal colon is particularly important in males aged over 48. A clear-cut risk of HGD in the diminutive polyps and in the middle age subjects has been also observed.

Bleeding Dieulafoy's-like lesions of the gut identified by capsule endoscopy.

Dieulafoy's-like lesions (DLs-like) represent a cause of obscure gastrointestinal bleeding, enteroscopy being the main diagnostic and therapeutic procedure. Frequently, more than one enteroscopy is needed to identify the bleeding vessel. In our practice, video capsule endoscopy (VCE) identified and guided therapy in four cases of DLs-like; three of them were localized on the small bowel. We report, for the first time, a diagnosis of colonic DL-like performed by colon capsule endoscopy. Two patients presented with severe cardiovascular disorders, being hemodynamically unstable during VCE examination. Based on the VCE findings, only one invasive therapeutic procedure per patient was necessary to achieve hemostasis. VCE and enteroscopy may be regarded as complementary procedures in patients with gut DLs-like.

Unknown complicated celiac disease as an unexpected finding in patients investigated with capsule endoscopy for Crohn's disease. A case series.

Atypical symptoms of celiac disease may cause a late diagnosis, revealed by the onset of complications, which may inaccurately be attributed to Crohn's disease, as manifestations frequently overlap. Assessing the entire small bowel mucosa, capsule endoscopy may be an accurate procedure in these challenging situations. We present four Crohn's disease patients diagnosed with ulcerative jejunoilieitis complicating celiac disease after capsule endoscopy procedure. In three of these patients, the ulcerative jejunoileitis led in time to stricture formation, suggesting Crohn's disease. Administration of non-steroidal anti-inflammatory drugs made the diagnosis even more difficult in one case. In patients with Crohn's disease not responding to immunosuppressive or biological treatment, complicated celiac disease should be considered and capsule endoscopy should be performed for reassessing the diagnosis.

The etiology of upper gastrointestinal bleeding in cirrhotic patients.

AIMS: To investigate the etiology of upper digestive hemorrhage in cirrhotic patients. PATIENTS AND METHODS: From November 2004 to December 2006, we performed a prospective study at the Regional Institute of Gastroenterology and Hepatology "O. Fodor" Cluj-Napoca. The study was performed on 1,284 patients with esophageal varices from the endoscopy records, diagnosed with liver cirrhosis based on clinical, biochemical and endoscopic information, documented from the observation sheet. During the periodical examinations, we observed and monitored the patients' variceal and non-variceal bleedings. RESULTS: Out of the 1,284 patients included in this study, there were 297 cases of upper digestive hemorrhage, the dominant etiology being the variceal bleeding (217 cases - 73%), and 80 (27%) cases of upper non-variceal digestive hemorrhage. Duodenal ulcer was the main cause for upper non-variceal digestive hemorrhage in case of cirrhotic patients considered for this study (33.75%), followed by gastric ulcer (21.25%), portal hypertensive gastropathy (17.5%), acute erosive gastritis (11.25%), Mallory-Weiss syndrome (6.25%), esophageal ulcer (5%), antral vascular ectasia (1.25%), duodenal polyps (1.25%) and exulcerated gastric tumor (1.25%). We also observed the cases of hemorrhagic relapse in the group of patients with variceal hemorrhages. Variceal bleedings are predominant in each Child-Pugh clinical category, but one must mention that the risk of variceal rupture increases with the severity of the hepatic disease. There were 8 deaths, all caused by esophageal variceal hemorrhages. CONCLUSIONS: In our study, almost 27% of cirrhotic patients with upper gastrointestinal hemorrhage had bleeding from a non-variceal source, the most common etiology being peptic ulcer. Variceal bleeding is more severe and bears a higher mortality rate than non-variceal bleeding.

Variceal bleeding in cirrhotic patients: risk factors, evolution, treatment.

OBJECTIVES: The aim of this study was to monitor the risk factors that trigger variceal bleeding in cirrhotic patients, assess the severity of the bleeding and the efficacy of the endoscopic hemostasis techniques, as well as the recurrence of bleeding episodes and the mortality rate. MATERIALS AND METHODS: The current study was a prospective one, and it was conducted in the period November 2004 - December 2006 in the "O. Fodor" Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca. It included 273 patients with upper gastrointestinal bleeding because of variceal rupture, assessed by emergency endoscopy. The patients included in the study met the clinical, biochemical, endoscopic and ultrasound criteria for liver cirrhosis. Its etiology and staging were documented from the patients' observation charts. RESULTS: Out of the 273 cases of variceal bleeding there were 255 (93.4%) cases of bleeding from esophageal varices and 18 (6.6%) from gastric varices. Variceal bleeding episodes were more frequent in patients with alcoholic liver cirrhosis (51.28%). Most patients with variceal bleeding were in Child class B or C (77%). Mortality because of variceal hemorrhage was 2.93% in the study group. A number of 148 patients were treated by sclerotherapy and 125 patients with elastic ligatures. Bleeding relapses occurred in 65 (23.8%) patients within the study group, 43 men and 22 women. Variceal bleeding relapses were more frequent after sclerotherapy than after elastic ligatures. CONCLUSIONS: Variceal bleeding occurred more frequently in patients with alcoholic cirrhosis stage Child C. In the current study mortality was relatively low. The treatment of bleeding recurrence is more difficult, hence variceal rupture prevention and application of elastic ligatures represent a therapeutic necessity.

Non-variceal upper gastrointestinal bleeding: clinical, therapeutic and evolution aspects. Comparison between a tertiary medical center and a municipal hospital.

Upper gastrointestinal bleeding (UGIB) is one of the most common emergencies in gastroenterology practice. In recent years, the introduction of urgent upper gastrointestinal endoscopy (UGIE) and of the treatment with proton pump inhibitors (PPIs) in high doses has resulted in an improvement of the treatment outcome in patients with UGIB, but without a significant improvement in mortality rates. In our study we compared the epidemiological, clinical, therapeutic, and prognostic aspects in patients with non-variceal UGIB admitted over a period of one year in a tertiary center where urgent UGIE is a routine procedure and in a municipal hospital where UGIE with endoscopic hemostasis is not available. Patients admitted to the tertiary medical center had more clinical and endoscopic severity factors compared to those from the municipal hospital: they were older, with more frequent intake of NSAIDs, several comorbidities, some of them severe, and more severe posthemorrhagic anemia. The endoscopic examination revealed that active bleeding and stigmata of recent hemorrhage were more frequent in these patients. Urgent UGIE and, where necessary because of lesions, endoscopic hemostasis were performed in most of these patients. Patients admitted to the municipal hospital were treated more frequently with high-dose intravenous PPIs. Patients undergoing urgent UGIE and endoscopic therapy had a shorter duration of hospitalization. However, there were no differences regarding the need for surgery or mortality rates. The results of our study are consistent with the literature.

The safety of endoscopic ultrasonography-guided drainage of pancreatic fluid collections without fluoroscopic control: a single tertiary center experience.

BACKGROUND: Endoscopic ultrasonography (EUS) is preferred for guiding drainage of pancreatic fluid collections, with a success rate exceeding 90% when fluoroscopy is used. When fluoroscopy cannot be used, drainage can still be performed, but no data regarding the safety of such a procedure have yet been published. AIM: To establish the safety of EUS-guided drainage without fluoroscopic control and to identify criteria for the selection of suitable patients. METHODS: The pancreatic fluid collections considered suitable for EUS-guided drainage were >5 cm in diameter, symptomatic, without ductal communication. We attempted EUS-guided drainage of PC prospectively in 24 patients: 9 with abscesses and 15 with pseudocysts. RESULTS: Drainage was successful in 20 cases (83.3%), with complete resolution after a median 18 months' follow-up. EUS-guided drainage failed in four patients (16.7%): one in the abscess group due to symptomatic pneumoperitoneum and three in the pseudocyst group due to thick wall. Drainage failure was associated with a diameter <6 cm and wall thickness >2 mm and was considered to be due to the sliding of the cystotome on the pseudocyst wall. During follow-up there was one procedure unrelated death (4.1%) and no pancreatic fluid collections relapses. CONCLUSIONS: Fluoroscopic control represents a helpful tool, but it is not always necessary for EUS-guided drainage of pancreatic fluid collections. EUS-guided drainage is possible, efficient and safe without fluoroscopy in selected pancreatic fluid collections with a diameter larger than 6 cm and a thin wall. Collections with a thick wall should be drained under fluoroscopy or referred directly for surgery.

How severe is chronic hepatitis with HCV genotype 1b? A study of 1,220 cases on the waiting list for antiviral therapy in Romania.

INTRODUCTION: Chronic HCV infection represents a public health problem in Romania, with a prevalence of 3.23-4.56%, and more than 5,000 patients on the waiting lists for antiviral therapy. AIM: To perform an evaluation of the severity of chronic HCV infection genotype 1b, and a quantification of patients with a low viral load, in order to quantify the number of patients who may be considered for shortened treatment duration. MATERIAL: Histological assessment and viral load were performed in 1,220 consecutive patients from the waiting list for antiviral therapy in 2009. The severity of chronic hepatitis was assessed by histological evaluation (the necrotic-inflammatory index - Metavir and the fibrosis score - Metavir). Viral load was measured by PCR and 400,000 UI/ml and 600,000 UI/ml were defined as thresholds for low versus high viral load We assessed the influence of age, sex, and viral load on necro-inflammatory activity and fibrosis. RESULTS: The mean age of the patients included was 48 ± 10.69 years and females predominated (58%). Many of them (60%) were in stage F3, with a high potential for disease progression in the next 10 years (necro-inflammatory activity was moderate to severe in over 90%). Almost half of the patients had low viral load, below 600,000 copies/ml. The viral load was significantly associated with the age (p< 0.001) and sex (p< 0.001) of the patients. CONCLUSION: Chronic HCV hepatitis in patients on the waiting lists for antiviral therapy in Romania has a high severity with important predictable consequences on the duration of life, complications and treatment costs. The strategy of shortening the duration of treatment would be beneficial for almost 50% of the patients.