The introduction of an early oral feeding strategy after PD reduced the time to resumption of adequate oral intake and length of hospital stay without negatively impacting postoperative morbidity.

IntroductionPublishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols.MethodsA systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty.ResultsThe number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02).ConclusionPublishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology.

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Background: PVE and ALPPS are offering a chance for resectability.ALPPS initial high M&M rates caused dispute. After tailoring selection criteria and modifying the procedure M&M decreased to acceptable figures in recent publications. The role of PVE/ALPPS in a high-volume centre is unclear. Referring to our own experience we aim to clarify this. Methods: We searched our own hospitals prospective database for ALPPS and PVE. Data for ALPPS were split in 2 groups (before and after world expert meeting February 2015). Results: From 01/2010 to 12/2016 we performed 1021 liver resections e 142 patients (14%) underwent left and right trisegmentectomies (50 after ALPPS, 48 after PVE). Number of yearly resections reached 200/year from 2015. PVE as stage 1 was used in 75 patients, 48 patients went to step 2. ALPPS Stage 1 was performed in 57, Stage 2 in 52 patients. Overall 132 patients were submitted to a hypertrophy concept resembling 13% of our patients. There was only a slight rise in the utilization of ALPPS concept from 2015 levelled out by the rise of total operations performed. Conclusion: 2 stage procedures are useful for 13% of patients in a high-volume centre. Still, they mark the high-end level of complex procedures with higher M&M than expected in liver surgery. The fact of > 140 publications for ALPPS in the last 2 years doesn't resemble the rise in the application of hypertrophy concepts in our data. Our data also show that PVE and ALPPS are not competing therapies e their use is rather complementary.