Randomised clinical trial: faecal microbiota transplantation for recurrent Clostridum difficile infection - fresh, or frozen, or lyophilised microbiota from a small pool of healthy donors delivered by colonoscopy.

BACKGROUND: Faecal microbiota transplantation (FMT) has become routine in managing recurrent C. difficile infection (CDI) refractory to antibiotics. AIM: To compare clinical response and improvements in colonic microbiota diversity in subjects with recurrent CDI using different donor product. METHODS: Seventy-two subjects with ≥3 bouts of CDI were randomised in a double-blind study to receive fresh, frozen or lyophilised FMT product via colonoscopy from 50 g of stool per treatment from eight healthy donors. Recipients provided stools pre- and 7, 14 and 30 days post-FMT for C. difficile toxin and, in a subset, microbiome composition by 16S rRNA gene profiling. RESULTS: Overall resolution of CDI was 87% during 2 months of follow-up after FMT. Stool samples before FMT had significantly decreased bacterial diversity with a high proportion of Proteobacteria compared to donors. Cure rates were highest for the group receiving fresh product seen in 25/25 (100%), lowest for the lyophilised product 16/23 (78%; P = 0.022 vs. fresh and 0.255 vs. frozen) and intermediate for frozen product 20/24 (P = 0.233 vs. fresh). Microbial diversity was reconstituted by day 7 in the subjects receiving fresh or frozen product. Improvement in diversity was seen by day 7 in those randomised to lyophilised material with reconstitution by 30 days. CONCLUSIONS: Comparative efficacy in faecal microbiota transplantation was observed in subjects receiving fresh or frozen faecal product from the same donors. The lyophilised product had a slightly lowered efficacy compared with fresh product, but it resembled other treatments in microbial restoration 1 month after faecal microbiota transplantation.

Aspirin chemoprevention in patients with increased risk for colorectal cancer: a cost-effectiveness analysis.

BACKGROUND: Aspirin chemoprevention combined with colonoscopy screening is not cost-effective for the general population. However, the cost-effectiveness of aspirin in individuals with prior adenoma resection has not been evaluated. AIM: To evaluate the cost-effectiveness of aspirin chemoprevention alone and in combination with colonoscopy surveillance in patients with prior adenoma resection. METHODS: A model of the natural history of individuals with a history of endoscopic polypectomy was constructed. Four strategies were compared: (i) no intervention, (ii) routine colonoscopy surveillance, (iii) aspirin chemoprevention alone, and (iv) aspirin therapy combined with colonoscopy. RESULTS: Compared with no intervention, all other strategies were more costly but were associated with gains in years of life saved. Aspirin chemoprevention alone was associated with a gain of 0.0092 years, whereas routine colonoscopic surveillance and combination strategy were associated with further gains in years of life saved (0.0124 and 0.0138 years, respectively). Compared with no intervention, the incremental cost-effectiveness ratio of routine colonoscopy surveillance was $78,226 per year of life saved, and the incremental cost-effectiveness ratio of combination aspirin and colonoscopy was $60,942 per year of life saved. CONCLUSION: Aspirin chemoprevention combined with colonoscopic surveillance in post-polypectomy patients may be considered a cost-effective strategy.

Cost-effectiveness of hepatic venous pressure gradient measurements for prophylaxis of variceal re-bleeding.

BACKGROUND: Measurement of the hepatic venous pressure gradient may identify a sub-optimal response to drug prophylaxis in patients with a history of variceal bleeding. However, the cost-effectiveness of routine hepatic venous pressure gradient measurements to guide secondary prophylaxis has not been examined. METHODS: A Markov model was constructed using specialized software (DATA 3.5, Williamstown, MA, USA). Three strategies involved secondary prophylaxis without haemodynamic monitoring using beta-blockers alone, beta-blockers plus isosorbide mononitrate or endoscopic variceal ligation alone. Four strategies involved secondary prophylaxis with beta-blockers plus isosorbide mononitrate or beta-blockers alone, accompanied by one or two hepatic venous pressure gradient measurements to identify haemodynamic non-responders, who underwent endoscopic variceal ligation as an alternative. The total expected costs, variceal bleeding episodes and total deaths were calculated for each strategy over 3 years. RESULTS: The two most effective strategies were combination therapy alone and combination therapy with two hepatic venous pressure gradient measurements. The incremental cost-effectiveness ratio of the latter strategy was 136,700 dollars per year of life saved compared with combination therapy alone. The ratio improved as the time horizon was extended or the rates of variceal re-bleeding were increased. CONCLUSIONS: The cost-effectiveness of haemodynamic monitoring to guide secondary prophylaxis of recurrent variceal bleeding is highly dependent on local hepatic venous pressure gradient measurement costs, life expectancy and re-bleeding rates.

Where do ERCP, endoscopic ultrasound, magnetic resonance cholangiopancreatography, and intraoperative cholangiography fit in the management of acute biliary pancreatitis? A decision analysis model.

OBJECTIVES: The role of ERCP in acute biliary pancreatitis (ABP) is controversial. Magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasonography (EUS) are modalities for bile duct visualization that could lower costs and prevent ERCP-related complications. We analyzed costs and examined the cost-effectiveness of these modalities to define their role in ABP. METHODS: A decision analysis model of ABP was constructed. The strategies evaluated were 1) ERCP, 2) MRCP followed by ERCP if positive for common bile duct stones (CBDS) or if biliary sepsis ensued, 3) EUS followed by ERCP if positive or if biliary sepsis ensued, and 4) observation with intraoperative cholangiography at the time of cholecystectomy with ERCP only if biliary sepsis ensued. We compared costs and performed cost-effectiveness analysis between strategies at probabilities of CBDS ranging from 0% to 100%. The outcome measures were total costs and costs per ABP death prevented. RESULTS: At probabilities of CBDS < 15%, observation with intraoperative cholangiography is the least expensive strategy, whereas EUS and ERCP are the least expensive strategies at probabilities of 15-58% and >58%, respectively. In terms of cost-effectiveness, at probabilities of CBDS of 7-45%, EUS is the most cost-effective alternative, and at a probability of >45% ERCP is the most cost-effective option. CONCLUSIONS: Total costs and cost-effectiveness ratios of these strategies in patients with ABP are highly dependent on the probability of CBDS.