Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial.

BACKGROUND & AIMS: High-dose proton pump inhibitor (PPI) therapy has been recommended to prevent rebleeding of high-risk peptic ulcer (PU) after hemostasis. Vonoprazan has been proven to be noninferior to PPIs in various acid-related diseases. This study aimed to compare the efficacy of vonoprazan vs PPI for preventing high-risk PU rebleeding after hemostasis. METHODS: A multicenter, randomized, noninferiority study was conducted in 6 centers. Pre-endoscopic and endoscopic therapy were performed according to standard protocol. After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days, then 20 mg once a day for 28 days) or high-dose PPI (pantoprazole intravenous infusion 8 mg/h for 3 days, then omeprazole 20 mg twice a day for 28 days). The primary outcome was a 30-day rebleeding rate. Secondary outcomes included 3- and 7-day rebleeding rate, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay, and safety. RESULTS: Of 194 patients, baseline characteristics, severity of bleeding, and stage of ulcers were comparable between the 2 groups. The 30-day rebleeding rates in vonoprazan and PPI groups were 7.1% (7 of 98) and 10.4% (10 of 96), respectively; noninferiority (within 10% margin) of vonoprazan to PPI was confirmed (%risk difference, -3.3; 95% confidence interval, -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates in the vonoprazan group remained noninferior to PPI (P < .001 by Farrington and Manning test). All secondary outcomes were also comparable between the 2 groups. CONCLUSION: In patients with high-risk PU bleeding, the efficacy of vonoprazan in preventing 30-day rebleeding was noninferior to intravenous PPI. (ClinicalTrials.gov, Number: NCT05005910).

Factors that predict recurrent spontaneous bacterial peritonitis in cirrhotic patients.

BACKGROUND: The recurrence rate of spontaneous bacterial peritonitis (SBP) is increasing in cirrhotic patients. Antibiotic prophylaxis should be prescribed in all cirrhotic patients after the first episode of SBP. However, antibiotics promote the development of antibiotic-resistant bacteria. OBJECTIVE: To identify the factors that predict the recurrence of SBP after the first episode in cirrhotic patients to optimise the stratification for secondary antibiotic prophylaxis. METHODS: This retrospective study included 145 cirrhotic patients who had their first SBP episode during 2011-2015. The 86 patients who survived were divided into either the SBP recurrence or non-recurrence group according to patient SBP outcome during the 2-year follow-up. Demographical, clinical and laboratory parameters were recorded at SBP diagnosis and before hospital discharge. SBP recurrence rate, recurrence-free survival and in-hospital mortality were also analysed. RESULTS: The recurrence rate of SBP after the first episode was 69.8% (60/86), and the median recurrence-free survival time was 142 days. The in-hospital mortality rate was 40.7% (59/145). The significant predictive factors for recurrence of SBP were serum potassium ≥4 mEq/L (HR: 1.89; P = .028), serum albumin ≤2 g/dL (HR: 2.5; P = .003) at diagnosis of SBP and platelet count before discharge ≤100 000/microliter (HR: 1.93; P = .029). CONCLUSION: SBP frequently recurs in cirrhotic patients. Serum potassium ≥4 mEq/L, serum albumin ≤2g/dL at SBP diagnosis and platelet count ≤100 000/microliter before discharge were identified as factors that may predict the recurrence of SBP after the first episode.

Acute hepatitis A infection-associated hemophagocytic lymphohistiocytosis in adult presenting as impending acute liver failure: A case report and literature review.

Hemophagocytic lymphohistiocytosis has been reported as a severe complication of various viral infections but unusual for the hepatitis A virus. We report a case of 25-year-old man with hepatitis A infection-associated hemophagocytic lymphohistiocytosis and impending acute liver failure to emphasize the importance of early diagnosis and treatment of this condition.

Development and validation of a 90-day mortality prediction model following endobiliary drainage in patients with unresectable malignant biliary obstruction.

Background: Palliative endobiliary drainage is the mainstay treatment for unresectable malignant biliary obstruction (MBO). Despite optimal drainage, the survival benefit is arguable. This study aimed to identify factors predicting post-endoscopic drainage mortality and develop and validate a mortality prediction model. Methods: We retrospectively analyzed data for 451 patients with unresectable pancreatobiliary cancers undergoing first endoscopic retrograde cholangiopancreatography (ERCP)-guided endobiliary stent placement between 2007 and 2017. We randomly assigned patients in a 3:1 fashion into a derivation cohort (n=339) and validation cohort (n=112). Predictors for 90-day mortality post-stenting were identified from the derivation cohort. A prediction model was subsequently developed and verified with the validation cohort. Results: The overall 90-day mortality rate of the derivation cohort was 46.9%, and the mean age was 64.2 years. The 2 most common diagnoses were cholangiocarcinoma (53.4%) and pancreatic cancer (35.4%). In all, 34.2% had liver metastasis. The median total bilirubin (TB) level was 19.2 mg/dL, and the mean serum albumin was 3.2 g/dL. A metallic stent was used for 64.6% of the patients, and the median stent patency time was 63 days. A total of 70.8% had TB improvement of more than 50% within 2 weeks after stenting, and 14.5% were eligible for chemotherapy. Intrahepatic obstruction (OR=5.69; P=0.023), stage IV cancer (OR=3.01; P=0.001), pre-endoscopic serum albumin (OR=0.48; P=0.001), TB improvement within 2 weeks after stenting (OR=0.57; P=0.036), and chemotherapy after ERCP (OR=0.11; P<0.001) were associated with 90-day mortality after stenting. The prediction model was developed to identify the risk of death within 90 days post-stent placement. The AUROC was 0.76 and 0.75 in derivation and validation cohorts. Patients with a score ≥ 1.40 had a high likelihood of death, whereas those scoring < -1.50 had a low likelihood of death. Additionally, a score ≥ 0.58 provided a 75.2% probability of death, which highlights the usability of the model. Conclusions: This study proposes a useful validated prediction model to forecast the 90-day mortality of unresectable MBO patients after stenting. The model permits physicians to stratify the death risk and may be helpful to provide a proper palliative strategy.

Development and validation of a risk score for predicting clinical success after endobiliary stenting for malignant biliary obstruction.

BACKGROUND: Endoscopic drainage is the primary treatment for unresectable malignant biliary obstruction (MBO). This study developed and validated a pre-endoscopic predictive score for clinical success after stent placement. METHODS: Patients with unresectable MBO undergoing ERCP-guided endobiliary stent placement between 2007 and 2017 were randomly divided into derivation (n = 383) and validation (n = 128) cohorts. To develop the risk score, clinical parameters were built by logistic regression to predict (1) ≥ 50% total bilirubin (TB) resolution within 2 weeks and (2) bilirubin normalization (TB level <1.2 mg/dL) within 6 weeks following stenting. The scoring scheme was applied to the validation cohort to test its performance. RESULTS: A ≥ 50% TB resolution within 2 weeks was shown in 70.5% of cases. The risk scoring scheme had areas under the receiver operating characteristic curve (AUROC) of 0.70 (95% CI, 0.64-0.76) and 0.67 (95% CI, 0.57-0.77) in the derivation and validation cohorts, respectively. Thirty-one percent had TB normalization within 6 weeks after stenting. Significant predictors for TB normalization were extrahepatic biliary obstruction (odds ratio [OR] = 2.35), pre-endoscopic TB level (OR = 0.88), and stent type (OR = 0.42). The AUROC of a risk score for predicting TB normalization within 6 weeks was 0.78 (95% CI, 0.72-0.83) and 0.76 (95% CI, 0.67-0.86) in the derivation and validation cohorts, respectively. A score > 1.30 yielded a specificity of 98% and a positive predictive value of 84% for predicting TB normalization. A score of < -4.18 provided a sensitivity of 80%-90% and a negative predictive value of 90%-93% for predicting the absence of TB normalization. CONCLUSIONS: The pre-endoscopic scoring system comprising biliary obstruction level, liver biochemistry, and type of stent provides prediction indices for TB normalization within 6 weeks after stenting. This scheme may help endoscopists identify patients with unresectable MBO suited for palliative stenting.

Diagnosis and treatment of the afferent loop syndrome.

Afferent loop syndrome (ALS) is a mechanical complication that arises after gastric surgery with gastrojejunostomy reconstruction. This condition was first described in 1950 by Roux, Pedoussaut, and Marchal to post-gastrectomy patients with bilious vomiting. Acute ALS is associated with complete obstruction and considered a surgical emergency, whereas chronic ALS is mostly related to partial obstruction of the afferent loop. The delay in diagnosis may lead to intestinal ischemia, perforation and can be associated with a high mortality rate up to 60%. Surgery is usually the mainstay treatment of ALS, but endoscopic therapy, including stent placement in malignancy-related, anastomotic stricture dilation, has been evolving over the past recent years.