Background & Aims:Palliative patients with malignant hilar biliary obstruction typically undergo endoscopic or internal/external percutaneous biliary drainage. Both approaches may cause bacterial colonization of the bile ducts, requiring multiple reinterventions. The 90-day mortality rate after palliative drainage is reported to be up to 36%. Few patients become eligible for systemic treatment. Primary percutaneous stenting may avoid infectious complications. The aim of this study was to investigate primary percutaneous stenting in palliative patients with malignant hilar biliary obstruction. Methods:We performed a single-arm phase II trial. Primary percutaneous stenting was performed with uncovered self-expandable metal stents across the hilar tumor without crossing the ampulla. The puncture tract was sealed without leaving an external drain. Outcomes included drainage-related severe complications and the proportion of patients receiving systemic treatment after drainage. Results:From October 2020 until June 2023, 67 patients were included, with perihilar cholangiocarcinoma in 27 patients (40.3%), intrahepatic cholangiocarcinoma in 23 patients (34.3%), gallbladder cancer in nine patients (13.4%), and other tumors in eight patients (12.0%). Drainage-related severe complications within 90 days were observed in 12 patients (17.9%); two patients (3.0%) developed acute cholecystitis, one patient (1.5%) had a biliary leak, three patients (4.5%) had hemorrhage, and six patients (9.0%) had persistent jaundice. No drainage-related 90-day mortality was observed. Cholangitis or pancreatitis was never observed after the first drainage. Palliative systemic treatment was started in 42 patients (62.7%). Conclusions:Primary percutaneous stenting for patients with malignant hilar biliary obstruction had a low incidence of drainage-related complications without any cholangitis or pancreatitis after the first drainage. Palliative systemic treatment was never withheld because of drainage-related complications or inadequate drainage. These results compare favorably to both endoscopic and internal/external percutaneous drainage. Impact and implications:This study demonstrates that primary percutaneous stenting in patients with malignant hilar biliary obstruction results in a low rate of drainage-related complications and enables initiation of systemic therapy in the majority of patients. These findings are clinically relevant for gastroenterologists, interventional radiologists, and oncologists aiming to optimize palliative care while minimizing infectious risks. The approach may offer a safe and effective alternative to conventional drainage strategies, although confirmation in comparative trials is needed to support broader implementation.

[This corrects the article DOI: 10.1016/j.jhepr.2025.101541.].

Background:Major liver resection is often required for complete clearance of colorectal liver metastases (CRLM). Patients with insufficient future liver remnant (FLR) volume/function are at high risk of post-hepatectomy liver failure (PHLF) and require FLR hypertrophy-inducing procedures to enable safe resection. The most recent variant of these procedures is combined portal and hepatic vein embolization (PVE/HVE). The DRAGON 1 trial evaluates the safety and efficacy of PVE/HVE, while assessing recruitment potential for the DRAGON 2 randomized trial. Methods:DRAGON 1 is a prospective, single-arm, international, multicenter trial. Patients with upfront unresectable CRLM due to a small FLR were included. The primary outcome was the ability of centers to recruit three patients and perform PVE/HVE and liver resection without 90-day mortality. Secondary outcomes included recruitment capacity, PVE/HVE technical details, FLR volume changes, complications, and resection rates. The study is registered at ClinicalTrials.gov, identifier: NCT04272931. Findings:In total, 102 patients were included from 43 centers. Twenty-four centers (24/43 = 56%) recruited three or more patients, and 20 centers (20/43 = 47%) achieved this without 90-day mortality. Of 96 patients undergoing PVE/HVE, no post-embolization mortality occurred, though major complications were reported in two patients. Resection was completed in 86 patients (86/96 = 90%), with seven patients (7/86 = 8%) dying within 90 days. PHLF grade B/C (International Study Group of Liver Surgery criteria) occurred in 19 patients (19/86 = 22%). Interpretation:DRAGON 1 demonstrates that PVE/HVE is safe, with no embolization-related mortality, low morbidity, and high resection rates in upfront unresectable CRLM. Funding:The Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet.

This phase II study compared radiofrequency ablation, microwave ablation, and cryoablation for early-stage breast cancer, demonstrating that cryoablation achieved the highest complete ablation rate with no complications, supporting its selection for a phase III trial.

433 Background: In the ABC-trials, the 3-year overall survival (OS) was only 2.8% for patients with advanced intrahepatic cholangiocarcinoma (iCCA) confined to the liver who received systemic gemcitabine with cisplatin. Hepatic arterial infusion pump (HAIP) combined with systemic chemotherapy had a pooled 3-year OS of 39.5% in a recent meta-analysis. HAIP chemotherapy involves continuous administration of floxuridine (FUDR) directly into the hepatic artery using a subcutaneous pump. The aim of this study was to prospectively assess the effectiveness of HAIP with systemic chemotherapy in patients with advanced iCCA confined to the liver in the Netherlands. Methods: We performed a single arm phase II trial in 3 centers in the Netherlands. Six cycles of HAIP chemotherapy with floxuridine were scheduled with 8 cycles of concurrent systemic chemotherapy with gemcitabine and cisplatin, if not administered previously. The primary endpoint was OS, secondary endpoints were progression-free survival (PFS) and objective response. Results: From January 2020 until September 2022, 50 patients with advanced iCCA were included. Combined HAIP and systemic chemotherapy was administered to 38 patients (76.0%). Eleven patients (22.0%) received HAIP chemotherapy alone, because they had received systemic treatment before enrollment. One patient (2.0%) didn’t start treatment, because he died 19 days after pump implantation due to COVID-19. The median follow-up was 26.4 months (95% CI: 21.7 – 39.0). The median OS was 22.1 months (95% CI: 19.7 – not reached). The 1-year OS rate was 80.0% (95% CI: 69.6% – 91.9%); the 3-year OS rate was 28.6% (95% CI: 16.0% – 51.2%). The median PFS was 10.0 months (95% CI: 8.7 – 12.2). An objective response on imaging (RECIST) was achieved in 27 patients (54.0%) and disease control at 6 months in 43 patients (86.0%). Four patients (8.0%) underwent a resection after HAIP chemotherapy of whom 2 patients had a complete pathologic response. Conclusions: Combined HAIP with systemic chemotherapy for patients with advanced iCCA was associated with a favorable 3-year OS of 28.6% compared with 2.8% after systemic chemotherapy alone in the ABC trials. Clinical trial information: NL8234 .

Objective: To evaluate patient reported outcome measures after early clot removal for acute deep vein thrombosis (DVT), using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36). Methods: Cross sectional design. Patients who underwent early clot removal between June 2012 and November 2021 were asked to complete the two questionnaires once. Lower CIVIQ-20 and higher SF-36 scores indicate better quality of life (QoL). Primary endpoints were the median scores. The one sample Wilcoxon signed rank test was used to compare SF-36 physical and mental component summary (PCS and MCS) to the normative and CIVIQ-20 to the minimum. Secondary, non-parametric independent t test or Fisher's exact test examined how age, sex, body mass index, stent placement, re-intervention, and time of questionnaire completion related to QoL. Multivariable linear regression tested whether various variables were associated with QoL. Results: The response rate was 73.5% (n = 39). Median time of questionnaire completion was 1.8 years (interquartile range [IQR] 3.1) after clot removal. The median CIVIQ-20 of 29.0 (IQR 28.0) was slightly higher than the minimum value 20.0 (p < .001). The median PCS (50.5, IQR 16.6) and median MCS (50.2, IQR 14.2) did not differ from the normative of 50.0. However, wide IQRs indicated impairments for a subgroup of patients. None of the tested variables affected QoL except for the finding that re-interventions had a significantly negative impact on the SF-36 MCS (standardised b coefficient of -0.4, p = .030). Conclusion: Overall patient reported outcome measures were satisfactory after early clot removal, but impaired physical and mental functioning levels were present in a subgroup of patients. Re-interventions were found to have a negative impact on mental QoL. This finding was independent of time that had passed between the procedure and questionnaire completion. This study emphasises that mental functioning deserves attention, besides the widely recognised physical consequences after invasive acute iliofemoral DVT treatment. (c) 2024 The Authors. Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). Article history: Received 30 August 2023, Revised 24 November 2023, Accepted 29 December 2023,

BACKGROUND:Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. METHODS:We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. FINDINGS:Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). INTERPRETATION:The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. FUNDING:Atrium Maquet Getinge Group.

Objective To determine the efficacy of genicular artery embolisation (GAE) compared with sham GAE for pain reduction in patients with symptomatic mild-to-moderate knee osteoarthritis (KOA).Design Double-blind randomised sham-controlled clinical trial conducted from June 2019 to December 2021. The follow-up period was 4 months.Setting Single-centre study conducted at a university medical centre in Rotterdam, Netherlands.Participants 58 adults with symptomatic mild-to-moderate KOA not improving with conservative treatment.Interventions Participants were randomised to receive either GAE treatment or a sham GAE treatment.Main outcome measures The primary outcome was reduction of pain measured with the Knee Injury and Osteoarthritis Outcome Score pain subscale (0–100, with 0 representing the worst pain outcome and 100 the best) after 4 months. Outcomes were assessed at baseline and 1 and 4 months.Results From June 2019 to December 2021, 58 patients were included. 29 patients were randomised to the GAE group and 29 to the sham group. All participants completed the study. The mean pain reduction after 4 months was 21.4 (95% CI 13.9 to 28.8) for the GAE group and 18.4 points (95% CI 11.6 to 25.1) for the sham group. The between-group difference for the mean pain reduction was 3.0 (95% CI −7.1 to 13.0) with an estimated Cohen’s d effect size of d = 0.15 (95% CI −0.37 to 0.66). Group allocation was not a significant contributor to pain reduction (p = 0.31). No serious adverse events (AEs) occurred. 23 mild AEs occurred in the GAE group and 5 in the sham group.Conclusion We did not establish a clinical effect of GAE in patients with mild-to-moderate KOA as GAE produced a similar effect on pain reduction as a sham GAE procedure.Trial registration number NCT03884049.

Intrahepatic arterioportal fistula (IAPF) is a rare cause of portal hypertension. Treatment is usually aimed at restoring the normal portal hemodynamics by obliterating the shunt. This report describes a case of idiopathic IAPF with severe portal hypertension complicated by portal enteropathy with vomiting, gastrointestinal hemor-rhage and sepsis. The patient was successfully treated with portal embolization. ( J CLIN EXP HEPA-TOL 2024;14:101295)

BackgroundAblation zone segmentation in contrast-enhanced computed tomography (CECT) images enables the quantitative assessment of treatment success in the ablation of liver lesions. However, fully automatic liver ablation zone segmentation in CT images still remains challenging, such as low accuracy and time-consuming manual refinement of the incorrect regions.PurposeTherefore, in this study, we developed a semi-automatic technique to address the remaining drawbacks and improve the accuracy of the liver ablation zone segmentation in the CT images.MethodsOur approach uses a combination of a CNN-based automatic segmentation method and an interactive CNN-based segmentation method. First, automatic segmentation is applied for coarse ablation zone segmentation in the whole CT image. Human experts then visually validate the segmentation results. If there are errors in the coarse segmentation, local corrections can be performed on each slice via an interactive CNN-based segmentation method. The models were trained and the proposed method was evaluated using two internal datasets of post-interventional CECT images (n1$n_{1}$ = 22, n2$n_{2}$ = 145; 62 patients in total) and then further tested using an external benchmark dataset (n3$n_{3}$ = 12; 10 patients).ResultsTo evaluate the accuracy of the proposed approach, we used Dice similarity coefficient (DSC), average symmetric surface distance (ASSD), Hausdorff distance (HD), and volume difference (VD). The quantitative evaluation results show that the proposed approach obtained mean DSC, ASSD, HD, and VD scores of 94.0%, 0.4 mm, 8.4 mm, 0.02, respectively, on the internal dataset, and 87.8%, 0.9 mm, 9.5 mm, and -0.03, respectively, on the benchmark dataset. We also compared the performance of the proposed approach to that of five well-known segmentation methods; the proposed semi-automatic method achieved state-of-the-art performance on ablation segmentation accuracy, and on average, 2 min are required to correct the segmentation. Furthermore, we found that the accuracy of the proposed method on the benchmark dataset is comparable to that of manual segmentation by human experts (p$p$ = 0.55, t$t$-test).ConclusionsThe proposed semi-automatic CNN-based segmentation method can be used to effectively segment the ablation zones, increasing the value of CECT for an assessment of treatment success. For reproducibility, the trained models, source code, and demonstration tool are publicly available at .

IntroductionThis study investigates the incidence of extrahepatic perfusion and incomplete hepatic perfusion at intraoperative methylene blue testing and on postoperative nuclear imaging in patients undergoing hepatic arterial infusion pump (HAIP) chemotherapy.MethodsThe first 150 consecutive patients who underwent pump implantation in the Netherlands were included. All patients underwent surgical pump implantation with the catheter in the gastroduodenal artery. All patients underwent intraoperative methylene blue testing and postoperative nuclear imaging (99mTc-Macroaggregated albumin SPECT/CT) to determine perfusion via the pump.ResultsPatients were included between January-2018 and December-2021 across eight centers. During methylene blue testing, 29.3% had extrahepatic perfusion, all successfully managed intraoperatively. On nuclear imaging, no clinically relevant extrahepatic perfusion was detected (0%, 95%CI: 0.0-2.5%). During methylene blue testing, 2.0% had unresolved incomplete hepatic perfusion. On postoperative nuclear imaging, 8.1% had incomplete hepatic perfusion, leading to embolization in only 1.3%.ConclusionMethylene blue testing during pump placement for intra-arterial chemotherapy identified extrahepatic perfusion in 29.3% of patients, but could be resolved intraoperatively in all patients. Postoperative nuclear imaging found no clinically relevant extrahepatic perfusion and led to embolization in only 1.3% of patients. The role of routine nuclear imaging after HAIP implantation should be studied in a larger cohort.

Background and aims: Abdominal aortic aneurysm (AAA) patients undergo uniform surveillance programs both leading up to, and following surgery. Circulating biomarkers could play a pivotal role in individualizing surveillance. We applied a multi-omics approach to identify relevant biomarkers and gain pathophysiological insights. Materials and methods: In this cross-sectional study, 108 AAA patients and 200 post-endovascular aneurysm repair (post-EVAR) patients were separately investigated. We performed partial least squares regression and ingenuity pathway analysis on circulating concentrations of 96 proteins (92 Olink Cardiovascular-III panel, 4 ELISA-assays) and 199 metabolites (measured by LC-TQMS), and their associations with CT-based AAA/sac volume. Results: The median (25th-75th percentile) maximal diameter was 50.0 mm (46.0, 53.0) in the AAA group, and 55.4 mm (45.0, 64.2) in the post-EVAR group. Correcting for clinical characteristics in AAA patients, the aneurysm volume Z-score differed 0.068 (95 %CI: (0.042, 0.093)), 0.066 (0.047, 0.085) and -0.051 (-0.064, -0.038) per Z-score valine, leucine and uPA, respectively. After correcting for clinical characteristics and orthogonalization in the post-EVAR group, the sac volume Z-score differed 0.049 (0.034, 0.063) per Z-score TIMP-4, -0.050 (-0.064, -0.037) per Z-score LDL-receptor, -0.051 (-0.062, -0.040) per Z-score 1-OG/2-OG and -0.056 (-0.066, -0.045) per Z-score 1-LG/2-LG. Conclusions: The branched-chain amino acids and uPA were related to AAA volume. For post-EVAR patients, LDLreceptor, monoacylglycerols and TIMP-4 are potential biomarkers for sac volume. Additionally, distinct markers for sac change were identified.

Objective: To evaluate the efficacy of endovascular embolization of pelvic varicose veins in the treatment of pelvic venous disorders (PeVD).Methods: A single-center retrospective study was performed, including 156 women referred to the Erasmus University Medical Center between January 2011 and October 2020 for an evaluation of PeVD.Data on presenting symptoms, clinical workup, treatment, and clinical outcomes were collected.The primary end point was resolution of symptoms after treatment.Secondary outcomes were correlation between symptoms at presentation and relief of symptoms after treatment, minor or major procedural complications, recurrences, and additional treatments needed.Results: Ninety patients underwent a pelvic phlebography, of which 75 received embolization of pelvic varicose veins.Median follow-up after phlebography was 13.2 months (interquartile range, 6.0-40.1 months).Of the treated patients, 53 (70.7%) had partial or complete relief of symptoms.Forty-six women (61.3%) who received embolization of pelvic varicose veins required additional treatments for leg and/or vulvar varicose veins.Conclusions: This study found that endovascular embolization of pelvic varicose veins can be an effective treatment for PeVDs.However, additional treatments are often required for leg and/or vulvar varicose veins.(

Purpose: Genicular artery embolization is a novel minimally invasive procedure used to alleviate pain in patients with symptomatic knee osteoarthritis. The target of this treatment is peri-genicular angiogenesis, which has been stated to be a contributor to KOA pain. The aim of GAE is to reduce blood flow to the hyperaemic synovium through embolization and subsequently reduce synovitis and the pain it produces. Multiple cohort studies have shown promising results, however, data from a randomized controlled trial is lacking. Therefore, we conducted a randomized sham controlled trial to investigate whether GAE provides clinically relevant pain reduction in KOA patients resistant to conservative therapy.

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Background: Surveillance programs in abdominal aortic aneurysms (AAA) are mainly based on imaging and leave room for improvement to timely identify patients at risk for AAA growth. Many biomarkers are dysregulated in patients with AAA, which fuels interest in biomarkers as indicators of disease progression. We examined associations of 92 cardiovascular disease (CVD)-related circulating biomarkers with AAA and sac volume. Methods: In a cross-sectional analysis, we separately investigated (1) 110 watchful waiting (WW) patients (undergoing periodic surveillance imaging without planned intervention) and (2) 203 patients after endovascular aneurysm repair (EVAR). The Cardiovascular Panel III (Olink Proteomics AB, Sweden) was used to measure 92 CVD-related circulating biomarkers. We used cluster analyses to investigate protein-based subphenotypes, and linear regression to examine associations of biomarkers with AAA and sac volume on CT scans. Results: Cluster analyses revealed two biomarker-based subgroups in both WW and EVAR patients, with higher levels of 76 and 74 proteins, respectively, in one subgroup versus the other. In WW patients, uPA showed a borderline significant association with AAA volume. Adjusting for clinical characteristics, there was a difference of −0.092 (−0.148, −0.036) loge mL in AAA volume per SD uPA. In EVAR patients, after multivariable adjustment, four biomarkers remained significantly associated with sac volume. The mean effects on sac volume per SD difference were: LDLR: −0.128 (−0.212, −0.044), TFPI: 0.139 (0.049, 0.229), TIMP4: 0.110 (0.023, 0.197), IGFBP-2: 0.103 (0.012, 0.194). Conclusion: LDLR, TFPI, TIMP4, and IGFBP-2 were independently associated with sac volume after EVAR. Subgroups of patients with high levels of the majority of CVD-related biomarkers emphasize the intertwined relationship between AAA and CVD. ClinicalTrials.gov Identifier: NCT03703947.

Purpose Peptide receptor radionuclide therapy (PRRT) using [ 177 Lu]Lu-DOTATATE has been shown to effectively prolong progression free survival in grade 1–2 gastroenteropancreatic neuroendocrine tumours (GEP-NET), but is less efficacious in patients with extensive liver metastases. The aim was to investigate whether tumour uptake in liver metastases can be enhanced by intra-arterial administration of [ 177 Lu]Lu-DOTATATE into the hepatic artery, in order to improve tumour response without increasing toxicity. Methods Twenty-seven patients with grade 1–2 GEP-NET, and bi-lobar liver metastases were randomized to receive intra-arterial PRRT in the left or right liver lobe for four consecutive cycles. The contralateral liver lobe and extrahepatic disease were treated via a “second-pass” effect and the contralateral lobe was used as the control lobe. Up to three metastases (> 3 cm) per liver lobe were identified as target lesions at baseline on contrast-enhanced CT. The primary endpoint was the tumour-to-non-tumour (T/N) uptake ratio on the 24 h post-treatment [ 177 Lu]Lu-SPECT/CT after the first cycle. This was calculated for each target lesion in both lobes using the mean uptake. T/N ratios in both lobes were compared using paired-samples t -test. Findings After the first cycle, a non-significant difference in T/N uptake ratio was observed: T/N IA = 17·4 vs. T/N control = 16·2 ( p = 0·299). The mean increase in T/N was 17% (1·17; 95% CI [1·00; 1·37]). Of all patients, 67% (18/27) showed any increase in T/N ratio after the first cycle. Conclusion Intra-arterial [ 177 Lu]Lu-DOTATATE is safe, but does not lead to a clinically significant increase in tumour uptake.