Value of immunonutrition in patients undergoing pancreatic resection: a trial sequential meta-analysis

Ricci, Claudio; Serbassi, Francesco; Alberici, Laura; Ingaldi, Carlo; Eusebi, Leonardo Henry; Raffele, Emilio De; Pironi, Loris; Sasdelli, Anna Simona; Mosconi, Cristina; Vicennati, Valentina; Casadei, Riccardo

doi:10.1016/j.hpb.2023.03.014

Cited by 2 publications

(2 citation statements)

References 39 publications

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“…A systematic review and meta‐analysis of two randomized trials and four nonrandomized studies comprising 712 patients also reported similar results with no difference between a conventional and Roux‐en‐Y reconstruction 31 . Two recent meta‐analyses concluded that immunonutrition reduced infectious complications and length of stay after a PD 32,33 . The PANasta trial represents the most robust analysis comparing two different techniques of pancreato‐jejunal anastomosis and reported no difference between the Blumgart and Cattel‐Warren techniques 34 .…”

Section: Pancreasmentioning

confidence: 77%

“…31 Two recent metaanalyses concluded that immunonutrition reduced infectious complications and length of stay after a PD. 32,33 The PANasta trial represents the most robust analysis comparing two different techniques of pancreato-jejunal anastomosis and reported no difference between the Blumgart and Cattel-Warren techniques. 34 Ellis et al have recently published the results of a robust RCT demonstrating a significant reduction in rates of CR-POPF and surgical site infections by implementing piperacillin-tazobactam in perioperative antibiotic prophylaxis for patients undergoing a PD.…”

Section: Risk Mitigation Strategies In Pdmentioning

confidence: 99%

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Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

Shrikhande,

Kunte,

Chopde

et al. 2023

Journal of Surgical Oncology

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Randomized controlled clinical trials (RCTs) are at the heart of “evidence‐based” medicine. Conducting well‐designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high‐volume centers with highly selected patients, which may not necessarily reflect a “real‐world” practice setting. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, the impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulations. Prospective data registries may also allow for quality benchmarking and auditing. There are several high‐quality RCTs providing evidence to support current practices in hepatopancreatobiliary (HPB) oncology. Evidence from big data bridges the gap in several instances where RCTs are lacking. In this article, we review the evidence from RCTs and big data in HPB oncology identify the existing lacunae, and discuss the future directions of research in HPB oncology.

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Section: Pancreasmentioning

confidence: 77%

Section: Risk Mitigation Strategies In Pdmentioning

confidence: 99%

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

Shrikhande,

Kunte,

Chopde

et al. 2023

Journal of Surgical Oncology

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Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis

Ricci,

Grego,

Alberici

et al. 2024

Ann Surg Oncol

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Background The superiority of early drain removal (EDR) versus late (LDR) after pancreaticoduodenectomy (PD) has been demonstrated only in RCTs. Methods A meta-analysis was conducted using a random-effects model and trial sequential analysis. The critical endpoints were morbidity, redrainage, relaparotomy, and postoperative pancreatic fistula (CR-POPF). Hemorrhage (PPH), delayed gastric emptying (DGE), length of stay (LOS), and readmission rates were also evaluated. Risk ratios (RRs) and mean differences (MDs) with a 95% confidence interval (CI) were calculated. Type I and type II errors were excluded, comparing the accrued sample size (ASS) with the required sample size (RIS). When RIS is superior to ASS, type I or II errors can be hypothesized. Results ASS was 632 for all endpoints except DGE and PPH (557 patients). The major morbidity (RR 0.55; 95% CI 0.32–0.97) was lower in the EDR group. The CR-POPF rate was lower in the EDR than in the LDR group (RR 0.50), but this difference is not statistically significant (95% CI 0.24–1.03). The RIS to confirm or exclude these results can be reached by randomizing 5959 patients. The need for percutaneous drainage, relaparotomy, PPH, DGE, and readmission rates was similar. The related RISs were higher than ASS, and type II errors cannot be excluded. LOS was shorter in the EDR than the LDR group (MD − 2.25; 95% CI − 3.23 to − 1.28). The RIS was 567, and type I errors can be excluded. Conclusions EDR, compared with LDR, is associated with lower major morbidity and shorter LOS.

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Value of immunonutrition in patients undergoing pancreatic resection: a trial sequential meta-analysis

Cited by 2 publications

References 39 publications

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

Big data and RCT's in surgical oncology: Impact on improving hepatopancreatobiliary cancer surgical care on the global stage

Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis

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