Dataset Information

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage.

ABSTRACT: BACKGROUND:The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD). METHODS/DESIGN:This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic wrapping of the GDA stump using the pedicled falciform ligament. The control group consists of 200 patients without the wrap. The primary endpoint is the rate of postoperative erosion hemorrhage of the GDA stump or hepatic artery within 3 months. The secondary endpoints are postpancreatectomy hemorrhage stratified according to the texture of the pancreas, postoperative pancreatic fistula (POPF), postoperative rate of therapeutic interventions, morbidity, and mortality. DISCUSSION:Only few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6-9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefore, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statistical significance. TRIAL REGISTRATION:clinicaltrials.gov, NCT02588066 ; Registered on 27 October 2015.

SUBMITTER: Mussle B

PROVIDER: S-EPMC5898061 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage.

Müssle Benjamin B Zühlke Leonie L Wierick Ann A Sturm Dorothée D Grählert Xina X Distler Marius M Rahbari Nuh N NN Weitz Jürgen J Welsch Thilo T

Trials 20180412 1

<h4>Background</h4>The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD).<h4>Methods/design</h4>This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic w ...[more]

PMID: 29650056

Similar Datasets

Project description:BackgroundThe use of the vancomycin wrap to pretreat the hamstring graft in anterior cruciate ligament reconstruction (ACLR) has grown in popularity since it was first described in 2012 and has significantly reduced rates of postoperative infection. However, it remains unknown if this antibiotic treatment affects the molecular composition of the graft.PurposeTo establish whether treatment with vancomycin at 5 mg/mL, the most commonly used concentration, alters the molecular function of the hamstring graft in ACLR.Study designControlled laboratory study.MethodsSurplus hamstring tendon collected after routine ACLR surgery was used for in vitro cell culture and ex vivo tissue experiments. Vancomycin was used at 5 mg/mL in RPMI or saline diluent to treat cells and tendon tissue, respectively, with diluent control conditions. Cell viability at 30, 60, and 120 minutes was assessed via colorimetric viability assay. Tendon cells treated with control and experimental conditions for 1 hour was evaluated using semiquantitative reverse transcription analysis, immunohistochemistry staining, and protein quantitation via enzyme-linked immunosorbent assay for changes in apoptotic, matrix, and inflammatory gene and protein expression.ResultsVancomycin treatment at 5 mg/mL significantly reduced tenocyte viability in vitro after 60 minutes of treatment (P < .05); however, this was not sustained at 120 minutes. Vancomycin-treated tendon tissue showed no significant increase in apoptotic gene expression, or apoptotic protein levels in tissue or supernatant, ex vivo. Vancomycin was associated with a reduction in inflammatory proteins from treated tendon supernatants (IL-6; P < .05).ConclusionVancomycin did not significantly alter the molecular structure of the hamstring graft. Reductions in matrix protein and inflammatory cytokine release point to a potential beneficial effect of vancomycin in generating a homeostatic environment.Clinical relevanceVancomycin ACL wrap does not alter the molecular structure of the ACL hamstring graft and may improve graft integrity.

Project description:BACKGROUND:The aim of this study is to understand the determinants of adherence to wrap-around care (WAC) by professional care providers working in child and family services. WAC is a care coordination method targeting families with complex needs. The core components of WAC involve activating family members and the social network, integrating the care provider network, and assessing, planning and evaluating the care process. WAC was introduced in the Netherlands using two approaches: the network approach (NA) and the team approach (TA). METHODS:A cross-sectional study was conducted using a digital questionnaire targeted at care providers. After imputation of missing data, univariate and multilevel regression analyses were conducted to study the associations between adherence to the core components of WAC, the determinants of adherence and background characteristics. RESULTS:In total 145 out of 275 care providers (52.7%) responded to the questionnaire. Multilevel regression analysis showed that self-efficacy of the care providers and the way WAC is organised (NA versus TA region) were significantly associated with adherence to core components of WAC. Self-efficacy was significantly associated with all WAC core components (activating family members and the social network: ? (95% confidence interval, CI)?=?.27(.04-.50), integrating the network of care providers: ? (95% CI)?=?.27(.05-.50) and assessing, planning and evaluating the care process: ? (95% CI)?=?.30(.08-.52)). The way WAC is organised was significantly associated to two core components (activating family members and the social network: ? (95% CI)?=?.18(0.1-.37) and integrating the network of care providers: ? (95% CI)?=?.25(.09-.42)). CONCLUSION:The way WAC is organised and the self-efficacy of care providers who use WAC are factors that are relevant for the redesign of the strategy for introducing WAC. Longitudinal research into the predictive value of determinants of adherence to WAC is advised.

Dataset Information

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage.

Publications

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets