12Fr-Pigtail Versus 14Fr-Balloon Percutaneous Radiologic Gastrostomy (PRG), Retrospective Evaluation of Outcomes and Complications; A Maastricht University Medical Centre Study

PURPOSE: To retrospectively compare tube and placement related results of a 12Fr-pigtail and a 14Fr-balloon gastrostomy tube. MATERIALS AND METHODS: All consecutive patients who underwent percutaneous radiologic gastrostomy (PRG) between January 2016 and June 2020 were enrolled in this retrospective single-center analysis. Follow-up for all patients was 180 days. Mortality after 30 days, technical success, days to first complication within 180 days, reason of unexpected visit (tube, anchor or pain related), and tube specific complications (obstruction, pain, luxation, leakage) were taken as outcome measures. Data were obtained from both PACS software and electronic health records. RESULTS: A total of 247 patients were enrolled (12Fr-pigtail: n?=?139 patients and 14Fr-balloon: n?=?108 patients). 30-day mortality was very low in both groups and never procedure related. Technical success was 99% in both groups. The average number of complications within 180 days after initial PRG placement was significantly higher in the 12Fr-pigtail group (12Fr-pigtail: 0.93 vs. 14Fr-balloon: 0.64, p?=?0.028). Time to first complication within 180 days was significantly longer in the 14Fr-balloon group (12Fr-pigtail: 29 days vs. 14Fr-balloon: 53 days, p?=?0.005). In the 14Fr-balloon group, the rate of tube-related complications (luxation and obstruction) was significantly lower compared to 12Fr-pigtail (29% vs. 45%, p?=?0.011). CONCLUSION: 14Fr-balloon gastrostomy tubes have significantly lower (tube-related) complications rates and longer time to first complication compared to 12Fr-pigtail tubes. No procedure-related mortality was observed in either group. Technical success was very high in both groups. Level of Evidence Level 3, non-controlled retrospective cohort study

Increased resectability after simultaneous portal and hepatic vein embolization (PVE/HVE) compared to PVE alone in patients with small FLRS – a DRAGON group analysis

Introduction: Major liver resections in patients with a small Future Liver Remnant (FLR) can only be performed safely after induction of adequate FLR-hypertrophy to reduce the risk of post-hepatectomy liver failure (PHLF). Hypertrophy induced by Portal Vein Embolization (PVE) is slow and 20-30% of patients are not resected after this procedure. Combining Portal and Hepatic Vein Embolization (PVE/HVE) accelerates FLR hypertrophy, whether this increases resectability is studied in this analysis. Methods: All participating centers in the DRAGON COLLABORATIVE that had already performed >5 PVE/ HVE between 2016 and 2019 were asked to contribute cases of PVE/HVE or PVE. Osirix MD was used for volumetric assessment. Multivariable analysis was performed for the endpoints: resectability, FLR hypertrophy, and major complications (Clavien-Dindo >IIIA). Results: From 7 DRAGON centers, 39 PVE/HVE and 160 PVE cases were included. After PVE/HVE, resectability (90% vs. 68%, p=0.007) and FLR hypertrophy (59% vs. 48%, p=0.02) were higher than PVE alone. 90-day mortality (3% vs. 16%, p=0.15) and major complications (26% vs. 34%, p=0.55) did not significantly differ between groups. PVE/HVE was not a significant risk factor for major complications, but it was an independent predictor for survival and hypertrophy. Results were confirmed via multivariable analysis. Conclusion: PVE/HVE resulted in increased resectablity and liver growth compared to PVE alone. Complications and mortality rate did not differ between PVE/HVE and PVE. Superiority of PVE/HVE over PVE will be investigated in the prospective DRAGON trials

Influence of cholestasis on portal vein embolization-induced hypertrophy of the future liver remnant

Purpose In the pre-clinical setting, hepatocellular bile salt accumulation impairs liver regeneration following partial hepatectomy. Here, we study the impact of cholestasis on portal vein embolization (PVE)-induced hypertrophy of the future liver remnant (FLR).Methods Patients were enrolled with perihilar cholangiocarcinoma (pCCA) or colorectal liver metastases (CRLM) undergoing PVE before a (extended) right hemihepatectomy. Volume of segments II/III was considered FLR and assessed on pre-embolization and post-embolization CT scans. The degree of hypertrophy (DH, percentual increase) and kinetic growth rate (KGR, percentage/week) were used to assess PVE-induced hypertrophy.Results A total of 50 patients (31 CRLM, 19 pCCA) were included. After PVE, the DH and KGR were similar in patients with CRLM and pCCA (5.2 [3.3-6.9] versus 5.7 [3.2-7.4] %, respectively, p = 0.960 for DH; 1.4 [0.9-2.5] versus 1.9 [1.0-2.4] %/week, respectively, p = 0.742 for KGR). Moreover, pCCA patients with or without hyperbilirubinemia had comparable DH (5.6 [3.0-7.5] versus 5.7 [2.4-7.0] %, respectively, p = 0.806) and KGR (1.7 [1.0-2.4] versus 1.9 [0.8-2.4] %/week, respectively, p = 1.000). For patients with pCCA, unilateral drainage in FLR induced a higher DH than bilateral drainage (6.7 [4.9-7.9] versus 2.7 [1.5-4.2] %, p = 0.012). C-reactive protein before PVE was negatively correlated with DH (rho = - 0.539, p = 0.038) and KGR (rho = - 0.532, p = 0.041) in patients with pCCA.Conclusions There was no influence of cholestasis on FLR hypertrophy in patients undergoing PVE. Bilateral drainage and inflammation appeared to be negatively associated with FLR hypertrophy. Further prospective studies with larger and more homogenous patient cohorts are desirable

Preoperative portal vein or portal and hepatic vein embolization: DRAGON collaborative group analysis.

The extent of liver resection for tumours is limited by the expected functional reserve of the future liver remnant (FRL), so hypertrophy may be induced by portal vein embolization (PVE), taking 6 weeks or longer for growth. This study assessed the hypothesis that simultaneous embolization of portal and hepatic veins (PVE/HVE) accelerates hypertrophy and improves resectability. All centres of the international DRAGON trials study collaborative were asked to provide data on patients who had PVE/HVE or PVE on 2016-2019 (more than 5 PVE/HVE procedures was a requirement). Liver volumetry was performed using OsiriX MD software. Multivariable analysis was performed for the endpoints of resectability rate, FLR hypertrophy and major complications using receiver operating characteristic (ROC) statistics, regression, and Kaplan-Meier analysis. In total, 39 patients had undergone PVE/HVE and 160 had PVE alone. The PVE/HVE group had better hypertrophy than the PVE group (59 versus 48 per cent respectively; P = 0.020) and resectability (90 versus 68 per cent; P = 0.007). Major complications (26 versus 34 per cent; P = 0.550) and 90-day mortality (3 versus 16 per cent respectively, P = 0.065) were comparable. Multivariable analysis confirmed that these effects were independent of confounders. PVE/HVE achieved better FLR hypertrophy and resectability than PVE in this collaborative experience

Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy

Study Purpose: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. Methods: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. Results: Not applicable. Conclusion: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR. Trial Registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019)

Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.

The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. Not applicable. DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR. Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019)

Dragon 1 Protocol Manuscript: Training, accreditation, implementation and safety evaluation of portal and hepatic vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy

Study purpose: the DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases.Methods: the DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection.Results: not applicable.Conclusion: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR.Trial registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).</p