Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases

Deshayes, Emmanuel; Piron, Lauranne; Bouvier, Antoine; Lapuyade, Bruno; Lermite, Émilie; Vallar, Laurent; Laurent, Césari; Pinaquy, Jean-Baptiste; Chevallier, P.; Dohan, Anthony; Rode, Agnès; Sengel, Christian; Guillot, Chloé; Quénet, François; Guiu, Boris

doi:10.1186/s12885-020-07065-z

Cited by 35 publications

(18 citation statements)

References 12 publications

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“…The HYPER-LIV01 trial (registration number: NCT03841305 ( http://www.clinicaltrials.gov )) is a multicentre French trial that is currently recruiting and will compare patients with operable CRLM with an FLR less than 30 per cent randomizing to either PVE or DVE. The FLR will be assessed not only for change in volume but also function using 99mTc-mebrofenin SPECT-CT and will add considerably to the evidence base for DVE 37 . In addition to the HYPER-LIV01 trial, the Maastricht Group are also running the prospective DRAGON-1 study (DRAGON-1 –Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE (registration number: NCT04272931 ( http://www.clinicaltrials.gov )) to assess safety and feasibility of DVE in patients with CRLM as a precursor to a randomized clinical trial comparing PVE and DVE (DRAGON-2) with the results awaited.…”

Section: Discussionmentioning

confidence: 99%

Portal vein embolization versus dual vein embolization for management of the future liver remnant in patients undergoing major hepatectomy: meta-analysis

et al. 2022

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Background This meta-analysis aimed to compare progression to surgery, extent of liver hypertrophy, and postoperative outcomes in patients planned for major hepatectomy following either portal vein embolization (PVE) or dual vein embolization (DVE) for management of an inadequate future liver remnant (FLR). Methods An electronic search was performed of MEDLINE, Embase, and PubMed databases using both medical subject headings (MeSH) and truncated word searches. Articles comparing PVE with DVE up to January 2022 were included. Articles comparing sequential DVE were excluded. ORs, risk ratios, and mean difference (MD) were calculated using fixed and random-effects models for meta-analysis. Results Eight retrospective studies including 523 patients were included in the study. Baseline characteristics between the groups, specifically, age, sex, BMI, indication for resection, and baseline FLR (ml and per cent) were comparable. The percentage increase in hypertrophy was larger in the DVE group, 66 per cent in the DVE group versus 27 per cent in the PVE group, MD 39.07 (9.09, 69.05) (P = 0.010). Significantly fewer patients failed to progress to surgery in the DVE group than the PVE group, 13 per cent versus 25 per cent respectively OR 0.53 (0.31, 0.90) (P = 0.020). Rates of post-hepatectomy liver failure 13 per cent versus 22 per cent (P = 0.130) and major complications 20 per cent versus 28 per cent (Clavien–Dindo more than IIIa) (P = 0.280) were lower. Perioperative mortality was lower with DVE, 1 per cent versus 10 per cent (P = 0.010) Conclusion DVE seems to produce a greater degree of hypertrophy of the FLR than PVE alone which translates into more patients progressing to surgery. Higher quality studies are needed to confirm these results.

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Section: Discussionmentioning

confidence: 99%

Portal vein embolization versus dual vein embolization for management of the future liver remnant in patients undergoing major hepatectomy: meta-analysis

et al. 2022

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“…Improving the therapeutic effect of hepatic arterial chemoembolization in the treatment of inoperable primary liver cancer patients is a current research hotspot; PLC usually has insipid onset and long incubation period and lacks effective early diagnosis methods clinically. Therefore, most clinically diagnosed PLC patients are middle and late cases without surgical indications [ 7 ]. TACE is the main treatment of this stage.…”

Section: Introductionmentioning

confidence: 99%

To Systematically Evaluate and Analyze the Efficacy and Safety of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Primary Liver Cancer

Xiao

Lan

Zhong

et al. 2022

Journal of Healthcare Engineering

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The efficacy and safety of transcatheter arterial chemoembolization (TACE) are systematically evaluated in the treatment of primary liver cancer, which provides a reference for clinical practice and more in-depth research. Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP, and WanFang Data, supplemented by other searches, collected all randomized controlled trials (RCT) comparing TACE combined with TACE alone for HCC. The meta-analysis, after selecting the literature, extracting data, and evaluating the methodological quality of the included studies following the inclusion criteria, was performed using RevMan 5.1 software. There was statistical difference in 3-year survival rate of TACE combined with heat treatment for advanced hepatocellular carcinoma (OR = 1.72,95%CI (1.22,2.41), P = 0.002 , I2 = 0%, and Z = 3.12), total effective rate (OR = 1.91,95%CI (1.31,2.78), P = 0.0008 , I2 = 0%, and Z = 3.37), quality-of-life improvement rate (OR = 2.29,95%CI (1.62,3.23), P < 0.00001 , I2 = 83%, and Z = 3.37), and complication rate (OR = 2.29,95%CI (1.62,3.23), P < 0.00001 , I2 = 83%, and Z = 3.37). Compared with TACE alone, TACE combined with hyperthermia can significantly improve the survival rate and recent efficacy of patients, improve the quality of life, and have a trend to reduce the incidence of toxicity. However, its long-term efficacy and more comprehensive safety need to be verified by more sample and high-quality RCT.

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“…This method was evaluated retrospectively and was able to show advantages over PVE alone [ 73 ]. Currently, HYPER-LIV01 is ongoing as a randomized controlled prospective trial that is testing PVE against PVE with HVE (NCT03841305) [ 74 ]. Note, the HVE may be particularly relevant for liver segment IV, as this is not addressed by classic PVE.…”

Section: Liver Resectionmentioning

confidence: 99%

Treatment of Intrahepatic Cholangiocarcinoma—A Multidisciplinary Approach

Krenzien

Nevermann

Krombholz

et al. 2022

Cancers

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Intrahepatic cholangiocarcinoma (iCC) is distinguished as an entity from perihilar and distal cholangiocarcinoma and gallbladder carcinoma. Recently, molecular profiling and histopathological features have allowed further classification. Due to the frequent delay in diagnosis, the prognosis for iCC remains poor despite major technical advances and multimodal therapeutic approaches. Liver resection represents the therapeutic backbone and only curative treatment option, with the functional residual capacity of the liver and oncologic radicality being deciding factors for postoperative and long-term oncological outcome. Furthermore, in selected cases and depending on national guidelines, liver transplantation may be a therapeutic option. Given the often advanced tumor stage at diagnosis or the potential for postoperative recurrence, locoregional therapies have become increasingly important. These strategies range from radiofrequency ablation to transarterial chemoembolization to selective internal radiation therapy and can be used in combination with liver resection. In addition, adjuvant and neoadjuvant chemotherapies as well as targeted therapies and immunotherapies based on molecular profiles can be applied. This review discusses multimodal treatment strategies for iCC and their differential use.

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Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases

Cited by 35 publications

References 12 publications

Portal vein embolization versus dual vein embolization for management of the future liver remnant in patients undergoing major hepatectomy: meta-analysis

Portal vein embolization versus dual vein embolization for management of the future liver remnant in patients undergoing major hepatectomy: meta-analysis

To Systematically Evaluate and Analyze the Efficacy and Safety of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Primary Liver Cancer

Treatment of Intrahepatic Cholangiocarcinoma—A Multidisciplinary Approach

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