Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn's Disease (Versus-CD): Data from the ENEIDA Registry.

BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.

Endoscopic retrograde cholangiopancreatography for the management of choledocholithiasis in older patients.

BACKGROUND: Older adults are increasing in number and frequently seeking hospital care for acute illness. We aimed to measure the utilization and safety of ERCP in patients aged 85 and older in our hospital. METHODS: This is a single-site, retrospective, observational and descriptive study. We obtained data about admissions and ERCP utilization from our hospital database. We reviewed medical and procedural records of patients aged 85 or older who underwent ERCP for choledocholithiasis between 2013 and 2019. We evaluated technical and medical adverse events after ERCP. RESULTS: 494 ERCP for choledocholithiasis were performed during this period and 154 (31%) were aged 85 or older. We identified 567 (4.8%) admissions for biliary tract diseases in the older population, and 27% of cases had required ERCP. In older patients, the rate of technical adverse events was around 10%. There was no statistical difference between the older and younger groups regarding technical complications (8.8 vs 9.7%; p=0.7). Besides, in 36% of cases, a medical event, decompensated comorbidity or geriatric syndromes appeared after ERCP. The overall mortality for any cause at six months was nearly 20%, and the survival rate was significantly lower in patients who develop adverse events (technical or medical). CONCLUSIONS: Our hospital experiences frequent utilization of ERCP by patients aged 85 and older. Although technical adverse event rates are similar to those of younger adults, medical events appear frequently. We plan to strengthen our care plans for older adults and hope to reduce the medical complications experienced post ERCP.

Effect of intracolonic volume on gastric sensory-motor responses in constipation-predominant irritable bowel syndrome.

BACKGROUND: Interaction between gut stimuli may induce symptom overlap in patients with functional gastrointestinal disorders. The aim is to determine the effect of increased volumes of colonic contents on gastric sensory/motor responses and satiety in patients with constipation-predominant irritable bowel syndrome (IBS-C) and overlapping dyspeptic symptoms, and a cohort of healthy subjects. METHODS: In 15 patients with IBS-C and 10 healthy subjects, the effect of real versus sham colonic filling with gas (1080 ml) on gastric sensitivity (measured by stepwise distensions of the stomach), gastric compliance, abdominal perception, and nutrient drink tolerance was studied on separate days. RESULTS: In healthy subjects, colonic gas filling induced an increment in gastric sensitivity to distension (mean score 2.0 ± 0.2 before, and 3.0 ± 0.4 after; p = 0.038). In IBS, basal sensitivity was greater and remained unchanged after colonic gas filling (score 4.0 ± 0.1 and 3.8 ± 0.3, respectively; p < 0.001 vs. basal in health). Colonic gas infusion induced abdominal symptoms that were significantly greater in IBS-C (score 2.6 ± 0.1) than in health (score 1.7 ± 0.4; p = 0.027), with minor changes in gastric tone, and no changes in gastric compliance in both groups. Colonic filling produced a profound reduction in nutrient drink tolerance in IBS (791 ± 87 ml sham filling, 491 ± 58 ml gas filling; p < 0.001) but only a minor reduction in health (940 ± 70 ml sham filling, 860 ± 94 ml gas filling; p = 0.223). CONCLUSIONS & INFERENCES: The volume of the colonic contents modulates satiety in patients with IBS-C, due to a general visceral pan-hypersensitivity. These effects should be considered in the choice of treatment for constipation in these patients.

Adverse Events and Acute Chronic Liver Failure in Patients With Cirrhosis Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter Matched-Cohort Study.

BACKGROUND: Data on the outcome of adverse events (AEs) and the risk of developing acute-on-chronic liver failure (ACLF) after ERCP in patients with cirrhosis are unknown. We examined the incidence and risk factors of post-ERCP AEs in patients with cirrhosis and the appearance of ACLF after ERCP. METHODS: In this multicenter, retrospective, matched-cohort study, we evaluated ERCPs performed from January 2002 to 2015. A group of patients with cirrhosis with non-ERCP interventions and one without interventions was also analyzed for the development of ACLF. RESULTS: A total of 441 ERCPs were analyzed; 158 in patients with cirrhosis (cases) and 283 in patients without cirrhosis (controls). The overall rate of AEs after all ERCPs was significantly higher in cases compared to controls (17% vs 9.5, p = 0.02). Cholangitis developed more in cases compared to controls (6.3% vs 1.8%; p = 0.01). In a subanalysis of those with sphincterotomy, the rate of bleeding was higher in those with cirrhosis (9.4% vs 3.4%; p = 0.03). Logistic regression identified cirrhosis (OR, 2.48; 95% CI, 1.36-4.53; p = 0.003) and sphincterotomy (OR, 2.66; 95% CI, 1.23-5.72; p = 0.01) as risk factors of AEs. A total of 18/158 (11.4%) cases developed ACLF after ERCP. ACLF occurred in 7/27 cases with post-ERCP AEs and in 11/131 without post-ERCP AEs (25.9% vs 8.3%; p = 0.01). A total of 3.2% (13/406) patients without interventions developed ACLF compared to 17.5% (102/580) who developed ACLF after non-ERCP interventions. Patients with decompensated cirrhosis at ERCP had a higher risk of developing ACLF (17% vs 6.8%; p = 0.04). Patients with a MELD score ≥ 15 were 3.1 times more likely (95% CI: 1.14-8.6; p = 0.027) to develop ACLF after ERCP. CONCLUSIONS: The rate of AEs after ERCP is higher in patients with cirrhosis compared to the non-cirrhotic population. The incidence of ACLF is higher in those with AEs after ERCP compared to those without AEs, especially cholangitis. The development of ACLF is common after ERCP and other invasive procedures. ACLF can be precipitated by numerous factors which include preceding events before the procedure, including manipulation of the bile duct, and AEs after an ERCP.

Rate of adverse events of gastroduodenal snare polypectomy for non-flat polyp is low: A prospective and multicenter study.

AIM: To evaluate the rate of adverse events (AEs) during consecutive gastric and duodenal polypectomies in several Spanish centers. METHODS: Polypectomies of protruded gastric or duodenal polyps ≥ 5 mm using hot snare were prospectively included. Prophylactic measures of hemorrhage were allowed in predefined cases. AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy. Patients were followed for 48 h, one week and 1 mo after the procedure. RESULTS: 308 patients were included and a single polypectomy was performed in 205. Only 36 (11.7%) were on prior anticoagulant therapy. Mean polyp size was 15 ± 8.9 mm (5-60) and in 294 cases (95.4%) were located in the stomach. Hemorrhage prophylaxis was performed in 219 (71.1%) patients. Nine patients presented AEs (2.9%), and 6 of them were bleeding (n = 6, 1.9%) (in 5 out of 6 AE, different types of endoscopic treatment were performed). Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and, consequently, were considered incidents. We did not find any independent risk factor of bleeding. CONCLUSION: Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.