The Efficacy Comparison of Endoscopic Bariatric Therapies: 6-Month Versus 12-Month Intragastric Balloon Versus Endoscopic Sleeve Gastroplasty.

INTRODUCTION: Intragastric balloon (IGB) insertion and endoscopic sleeve gastroplasty (ESG) are known to be effective and safe in achieving weight loss. The aim of this study was to compare the effects of a 6-month IGB therapy, a 12-month IGB therapy, and ESG. METHODS: We retrospectively analyzed the weight loss at IGB (Orbera) removal after 6 months (124 patients), at IGB (Orbera365) removal after 12 months (61 patients) and at 6 and 12 months after ESG (42 and 34 patients, respectively). Postprocedural care, including medication and diet, was the same for all procedures. RESULTS: Mean TBWL in patients undergoing IGB placement for 6 and 12 months and ESG after 6 and 12 months were 15.2, 15.8, 26.5, and 28.7 kg, respectively. There was no significant difference in the mean %TBWL in patients undergoing IGB placement for 6 or for 12 months (15.3% vs. 14.7%, P = 0.7). ESG patients showed a significantly higher mean %TBWL than IGB patients after 6 months (15.3 vs. 19.8, P = 0.005) and 12 months (14.7 vs. 22.5, P < 0.001). CONCLUSION: All three studied methods were effective for achieving weight loss. However, there was no significant difference between 6-month and 12-month IGB therapies outcomes. ESG appeared to be a more effective obesity treatment modality than IGB.

Ligation of oesophageal varices may increase formation of "deep" gastric collaterals.

BACKGROUND/AIMS: Endosonography (EUS) is rarely used in the routine diagnostic of portal hypertension in patients with cirrhosis even though it has significantly higher sensitivity for detection of varices than gastroduodenoscopy. The aim of this cross-sectional study was to assess the features of portal hypertension identified with EUS and to analyze the effect of variceal ligation on the prevalence of "deep" varices in subjects with cirrhosis. METHODOLOGY: A cohort of 121 patients was divided into 2 groups depending on whether they had a history of variceal bleeding treated with ligation or not. RESULTS: "Deep" oesophageal varices and large (> 5 mm) gastric varices occurred significantly more common in patients with previous banding. Also, large "deep" gastric varices occurred significantly more common in the banded group with no or small varices than in the not-banded group with similar endoscopy. Sixty percent of banded patients who had grade II/III oesophageal varices on endoscopy had large "deep" gastric varices comparing to 20% of not-banded with the same endoscopical findings (p = 0.04). CONCLUSION: Previous banding may increase the risk of the development of large "deep" oesophageal and gastric varices. Thus potential new indication for EUS in patients with cirrhosis could be a follow-up examination after successful eradication of varices.

A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of long-term treatment with prucalopride.

BACKGROUND: Randomized trials have confirmed the efficacy of prucalopride for the treatment of chronic constipation up to 12 weeks. This study aimed to assess the efficacy of prucalopride over a 24-week period (ClinicalTrials.gov: NCT01424228). METHODS: Adults with chronic constipation and ≤2 spontaneous complete bowel movements (SCBMs)/week were randomized to receive prucalopride 2 mg or placebo daily for 24 weeks. The primary endpoint was the proportion of patients achieving a mean of ≥3 SCBMs/week over the treatment period, assessed using daily e-diaries. Secondary outcomes and safety parameters were assessed throughout the study. KEY RESULTS: Overall, 361 patients were randomized and received prucalopride or placebo. Baseline characteristics were similar in the prucalopride (N = 181) and placebo (N = 180) groups. Mean age was 48.9 years (standard deviation, 16.0) and most patients were women. The proportion of participants achieving the primary endpoint was not statistically different between the prucalopride and placebo groups (25.1% vs 20.7%; p = 0.367). There was also no statistically significant difference between groups over the first 12-week period (prucalopride, 25.1%; placebo, 20.1%; p = 0.341). There were no statistically significant differences between groups for most secondary endpoints. No new safety concerns were identified. CONCLUSIONS & INFERENCES: This trial did not show statistically significant improvements in primary or secondary outcomes with prucalopride compared with placebo over 24 or 12 weeks. This is in contrast to the results of four previous 12-week trials, which demonstrated prucalopride to be significantly more effective than placebo. An extensive evaluation did not provide an explanation for the null efficacy results of this study.

5T4 oncofetal antigen in gastric carcinoma and its clinical significance.

OBJECTIVE: To evaluate the role of 5T4 antigen in gastric cancer progression and prognosis. DESIGN: A prospective study of 5T4 antigen expression in primary, secondary and recurrent gastric carcinoma, the relationship to selected prognostic parameters and the course of disease. PATIENTS: Eighty six patients operated on for gastric cancer. TISSUE: One hundred and twenty two gastric tumours were studied, including 86 primary carcinomas, 32 coexisting lymph node metastases and four recurrent carcinomas. METHODS: Immunohistochemistry using 5T4 monoclonal antibody on frozen sections. RESULTS: The 5T4 antigen was detected in 41% of primary gastric tumours including early gastric cancer. A strong relationship was found between 5T4 positivity and tumour histology. Thus, 52% of gastric carcinomas of intestinal type expressed 5T4 antigen compared with 28% of the diffuse type (P = 0.028). Among 16 sets of primary gastric carcinomas and regional lymph node metastases, coordinate 5T4 expression was seen in 14 cases; the other two showed acquisition of positivity on metastatic tumour cells (carcinomas of diffuse type). 5T4 antigen was detected more frequently in carcinomas with p53 accumulation compared with those with undetectable p53 levels (P = 0.015). The presence of 5T4 in cancer cells was correlated with poor short-term prognosis (24% vs 49% of 2 year survival for 5T4 positive and negative tumours respectively, P = 0.024). The effect on survival was evident in the p53 negative group, with patients 5T4 positive showing worse survival (28% vs 60% in 2 years). CONCLUSIONS: Our results suggest that the assessment of 5T4 expression in gastric carcinoma can be helpful in identifying patients with poor short-term prognosis.

Correlation between Endosonographic and Doppler Ultrasound Features of Portal Hypertension in Patients with Cirrhosis.

Purpose. Endoscopic ultrasound (EUS) permits the detailed visualization of clinically significant features of portal hypertension; however, it is an invasive procedure that is not widely available. The aim of this cross-sectional study was to determine whether a correlation exists between the features of portal hypertension detected using both Doppler ultrasound and EUS in subjects with liver cirrhosis. Materials and Methods. Analyzed cohort included 42 patients who underwent a detailed Doppler ultrasound focusing on the parameters of blood flow in the portal/splenic vein as well as an endoscopic/EUS procedure that included the assessment of the size and localization of "deep" varices. Results. The size of "deep" oesophageal varices detected with EUS exhibited no correlation with the parameters assessed by Doppler ultrasound. However, the size of the "deep" gastric varices detected using EUS correlated with the time averaged maximum velocity (T(max) as well as V(min), V(max)) for the portal vein using Doppler ultrasound and exhibited a correlation with the V(max) and T(max) for the splenic vein. No significant correlation was determined between the diameter of the azygous vein and the thickness of the gastric wall when seen on EUS versus the parameters measured with Doppler ultrasound. Conclusion. EUS provides important information regarding the features of portal hypertension, and in the case of "deep" oesophageal varices exhibits a limited correlation with the parameters detected by Doppler ultrasound. Thus, despite its invasiveness, EUS is a method that provides a reliable and unique assessment of the features of portal hypertension in patients with liver cirrhosis.

Upper gastrointestinal endosonography in patients evaluated for liver transplantation.

BACKGROUND: Endosonography (EUS), which merges endoscopic and ultrasound examinations, is a useful modality to display abnormal vessels that develop in the intrinsic circulation, frequently called "deep" varices. If these pathological veins exceed of 5 mm diameter, they significantly increase the risk of bleeding among patients with cirrhosis. In the most recent pilot study EUS proved useful to assess children for orthotopic liver transplantation (OLT). AIM: We performed a cross-sectional study of EUS on 33 (22 males and 11 females) adult cirrhotic subjects being assessed for OLT. MATERIALS/METHODS: We used an echoendoscope at 7.5 MHz/12 MHz/20 MHz to evaluate the esophagus and stomach, including "deep" periesophageal/perigastric varices (adjacent to the muscularis propria) and paraesophageal/paragastric varices (outside the muscularis propria). "Deep" varices were considered to be large if >5 mm. RESULTS: On endoscopy, 26 (79%) patients showed esophageal varices (EV), including 11 (33%) with large (>5 mm) varices. Gastric varices (GV) were observed in 13 (39%) subjects, with 3 patients displaying large (>5 mm) varices. On EUS large "deep" EV (both para and periesophageal) were observed in 12 (36%) subjects, among whom 5 (42%) did not have large varices on endoscopy. Large "deep" GV were found on EUS in 12 (36%) subjects. On endoscopy 4 of them (33%) showed no varices and 3 (25%) had small GV. CONCLUSIONS: EUS offers a precise evaluation of portal hypertension in OLT candidates. "Deep" potentially dangerous varices, which are undetected with routine endoscopy, were noted in a significant proportion of patients. The role of EUS in prioritizing subjects for OLT must be evaluated in a prospective study.

Is prevalence of PBC underestimated in patients with systemic sclerosis?

BACKGROUND: Clinically significant primary biliary cirrhosis occurs in 2.5% of patients with systemic sclerosis. Primary biliary cirrhosis-specific autoantibodies include anti-mitochondrial, anti-glycoprotein 210, and anti-sp100 antibodies. The majority of asymptomatic anti-mitochondrial-positive subjects express histological features of primary biliary cirrhosis. Early detection of primary biliary cirrhosis is important, as timely introduction of ursodeoxycholic acid may improve prognosis. The aim was to assess the prevalence of MIT3 IgG-anti-mitochondrial, gp210, sp100 and other autoantibodies in patients with systemic sclerosis and compare the clinical and biochemical parameters in those who are primary biliary cirrhosis-specific autoantibodies positive and negative. MATERIALS/METHODS: Fifty-two consecutive patients with systemic sclerosis were included. Thirty-three suffered from limited skin SS and 19 from diffuse SS. RESULTS: Eight (15%) patients with systemic sclerosis tested positive for primary biliary cirrhosis-specific autoantibodies. No significant differences were observed between primary biliary cirrhosis-specific autoantibodies positive and negative subjects in terms of various demographic, clinical or biochemical features. A trend towards increased prevalence of chronic fatigue in primary biliary cirrhosis-specific autoantibodies positive patients was observed. CONCLUSIONS: Primary biliary cirrhosis-specific autoantibodies were detected in 15% of the systemic sclerosis patients. Since patients with primary biliary cirrhosis-specific antibodies are at high-risk or do suffer from primary biliary cirrhosis, screening for primary biliary cirrhosis-specific autoantibodies may be considered during routine assessment of systemic sclerosis.