Data from: Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov - a retrospective analysis

Objectives: To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in ClinicalTrials.gov and published trials. Design: Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in ClinicalTrials.gov were eligible for inclusion. From ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in ClinicalTrials.gov and in the published paper were registered. Results: 105 trials were evaluated. Sixty-six trials (63%) were published. Thirty-one percent of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with lacking data in 22% and 11% of cases concerning the primary outcome measure and sample size. In 26% of the published papers data of sample size calculations were missing and discrepancies between sample size reporting in ClinicalTrials.gov and published trials existed. Conclusion: The quality of registration of randomised controlled trials still needs improvement

updated_english_version_of_trial_registration_study, final

An Excel file, with data extracted from the database: ClinicalTrials.gov and related publications. Abbreviations for column headings - see the uploaded ReadMe file

Rebleeding and mortality risk are increased by ACLF but reduced by pre-emptive TIPS

Background & aims: The relationship between acute-on-chronic liver failure (ACLF) and acute variceal bleeding (AVB) is poorly understood. Specifically, the prevalence and prognosis of ACLF in the context of AVB is unclear, while the role of transjugular intrahepatic portosystemic shunt (TIPS) in the management in patients with ACLF has not been described to date. Methods: A multicenter, international, observational study was conducted in 2,138 patients from 34 centers between 2011 and 2015. ACLF was defined and graded according to the EASL-CLIF consortium definition. Placement of pre-emptive TIPS (pTIPS) was based on individual center policy. Patients were followed-up for 1 year, until death or liver transplantation. Cox regression and competing risk models (Gray's test) were used to identify independent predictors of rebleeding or mortality. Results: At admission, 380/2,138 (17.8%) patients had ACLF according to EASL-CLIF criteria (grade 1: 38.7%; grade 2: 39.2%; grade 3: 22.1%). The 42-day rebleeding (19% vs. 10%; p <0.001) and mortality (47% vs. 10%; p <0.001) rates were higher in patients with ACLF and increased with ACLF grades. Of note, the presence of ACLF was independently associated with rebleeding and mortality. pTIPS placement improved survival in patients with ACLF at 42 days and 1 year. This effect was also observed in propensity score matching analysis of 66 patients with ACLF, of whom 44 received pTIPs and 22 did not. Conclusions: This large multicenter international real-life study identified ACLF at admission as an independent predictor of rebleeding and mortality in patients with AVB. Moreover, pTIPS was associated with improved survival in patients with ACLF and AVB. Lay summary: Acute variceal bleeding is a deadly complication of liver cirrhosis that results from severe portal hypertension. This study demonstrates that the presence of acute-on-chronic liver failure (ACLF) is the strongest predictor of mortality in patients with acute variceal bleeding. Importantly, patients with ACLF and acute variceal (re)bleeding benefit from pre-emptive (early) placement of a transjugular intrahepatic portosystemic shunt.CIBERehd is funded by Instituto de Salud Carlos III . Juan Carlos Garcia - Pagan is supported by Ministerio de Educacion y Ciencia ( SAF - 2016 - 75767 - R ). Virginia Hernández - Gea is supported by Instituto de Salud Carlos III ( PI14/00182 ). Gilberto Silva - Junior is funded by CAPES Foundation, Ministry of Education of Brazil , Brasilia, Brazil (process number BEX 5960/13 - 4 ). Edilmar Alvarado is supported by a Rio Hortega Fellowship grant form Instituto de Salud Carlos III . Jonel Trebicka is supported by grants from the Deutsche Forschungsgemeinschaft (SFB TRR57 to P18), European Union's Horizon 2020 Research and Innovation Programme ( Galaxy , No. 668031 and MICROB-PREDICT , No. 825694 ) and Societal Challenges - Health, Demographic Change and Wellbeing (No. 731875 ), and Cellex Foundation (PREDICT). Gu W is supported by the China Scholarships Council (CSC: #201906230332 ). Rafael Bañares is funded by Instituto de Salud Carlos III ( PI18/01901 ). Michael Praktiknjo is funded by the Ernst und Berta Grimmke Stiftung (Lfd.Nr. 5/19). The funders had no influence on study design, data collection and analysis, decision to publish or preparation of the manuscript