Enoxaparin prevents portal vein thrombosis and liver decompensation in patients with advanced cirrhosis.

BACKGROUND & AIMS: We performed a randomized controlled trial to evaluate the safety and efficacy of enoxaparin, a low-molecular-weight heparin, in preventing portal vein thrombosis (PVT) in patients with advanced cirrhosis. METHODS: In a nonblinded, single-center study, 70 outpatients with cirrhosis (Child-Pugh classes B7-C10) with demonstrated patent portal veins and without hepatocellular carcinoma were assigned randomly to groups that were given enoxaparin (4000 IU/day, subcutaneously for 48 weeks; n = 34) or no treatment (controls, n = 36). Ultrasonography (every 3 months) and computed tomography (every 6 months) were performed to check the portal vein axis. The primary outcome was prevention of PVT. Radiologists and hepatologists that assessed outcomes were blinded to group assignments. Analysis was by intention to treat. RESULTS: At 48 weeks, none of the patients in the enoxaparin group had developed PVT, compared with 6 of 36 (16.6%) controls (P = .025). At 96 weeks, no patient developed PVT in the enoxaparin group, compared with 10 of 36 (27.7%) controls (P = .001). At the end of the follow-up period, 8.8% of patients in the enoxaparin group and 27.7% of controls developed PVT (P = .048). The actuarial probability of PVT was lower in the enoxaparin group (P = .006). Liver decompensation was less frequent among patients given enoxaparin (11.7%) than controls (59.4%) (P < .0001); overall values were 38.2% vs 83.0%, respectively (P < .0001). The actuarial probability of liver decompensation was lower in the enoxaparin group (P < .0001). Eight patients in the enoxaparin group and 13 controls died. The actuarial probability of survival was higher in the enoxaparin group (P = .020). No relevant side effects or hemorrhagic events were reported. CONCLUSIONS: In a small randomized controlled trial, a 12-month course of enoxaparin was safe and effective in preventing PVT in patients with cirrhosis and a Child-Pugh score of 7-10. Enoxaparin appeared to delay the occurrence of hepatic decompensation and to improve survival.

Endoscopic Papillectomy for Ampullary Adenomas: Different Outcomes in Sporadic Tumors and Those Associated with Familial Adenomatous Polyposis.

BACKGROUND: Ampullary adenomas are rare and potentially malignant. Surgery was the standard treatment but endoscopic papillectomy (EP) is a possible alternative. AIM: We retrospectively evaluated the principal clinical outcomes of EP in all patients referred to our unit also dividing sporadic ampullary adenoma (SAA) from familial adenomatous polyposis (FAP)-associated adenomas. METHODS: All consecutive patients who underwent endoscopic papillectomy because of ampullary adenoma were considered. The primary outcome was the technical success of EP. Secondary outcomes included the number of procedures, the adverse event rate, the recurrence rate, the concordance of histology pre- and post-EP, and the evaluation of factors related to technical success. RESULTS: Between January 2001 and December 2015, sixty-two patients were included (21 FAP and 41 SAA). Technical success was achieved in 75.8% and was different in the two groups (FAP 95.2%, SAA 65.8%, p 0.025). Intraductal invasion was negatively associated with technical success (41.7% vs. 84.0%; p 0.005). The intestinal subtype was predictive of success (79.7% vs. 0%; p 0.012) as well as en bloc resection (90.3% vs. 61.3%; p 0.016). Adverse events were reported in 14 patients (22.6%). CONCLUSIONS: EP is an effective and safe procedure and is a viable alternative to surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03494543.

Endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction after failed ERCP in low performance status patients.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) with the placement of a biliary stent is the treatment of choice for palliation of malignant obstructive jaundice. In 5-10% of cases ERCP fails. In these cases an effective alternative is endoscopic ultrasonography-guided biliary drainage (EUS-BD). AIM: Evaluation of the principal clinical outcomes of direct transluminal EUS-BD. PATIENTS AND METHODS: This study is a retrospective analysis. All consecutive patients with malignant obstructive jaundice, in whom ERCP had failed, were enrolled. The primary outcome was the technical success of EUS-BD defined as the correct placement of the metal or plastic stent across the stomach or duodenum to the biliary tree. The most important secondary outcomes were early and late clinical success, both linked to the decrease of bilirubin haematic level. RESULTS: Between January 2011 and November 2017 thirty-six patients were included. Technical success was obtained in 91.6%. A clinical success, early or late was obtained in 75.8%. The ECOG performance status of less than 3 was correlated with clinical success. Adverse events occurred in 30.3% of patients. CONCLUSIONS: EUS-BD is an effective and safe procedure.