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Hypertrophy

Carcinoma, Hepatocellular

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Liver Extracts

All prospective patients who undergo unilobar SIRT for HCC at SGH or NCC are potential candidates for this study. The study aims to recruit 25 subjects and it is anticipated that 50% will be from SGH and 50% will be from NCC

Liver volume will be measure at 3 time points. All patients will undergo CT volumetry at baseline, 4-6 weeks and 8-12 weeks after SIRT. The images are then measured using a commercially available 3D software (Vital's Vitrea Advanced CT Liver Oncology package) and manually corrected, reviewed and resected by a single senior radiologist to ensure consistency in following the same anatomical landmarks.

CT volumetric measurement after Y90 radioembolization

Brian Goh, MBBS

Patients undergoing Y90 radioembolization to will be followed prospectively with CT volumetry to determine post-Y90 rate of liver hypertrophy.

Study protocol: Prospective study of early contra-lateral liver lobar hypertrophy after unilobar Y-90 selective internal radiation therapy (SIRT) in patients with hepatocellular carcinoma (HCC)

All patients scheduled to undergo unilobar (Right or left) SIRT with Y-90 for HCC at the Singapore General Hospital or the National Cancer Center Singapore during the study period may be enrolled. The target sample size is 25 over 2 years

Information on baseline demographics and disease staging, as well as pre- and post-treatment tumour and liver dimensions would be prospectively obtained.

The diagnosis of HCC is made based on current accepted diagnostic criteria ie. a characteristic appearance on contrast-enhanced quadriphasic CT scan and/or MRI, raised serum AFP levels and the presence of known risk factors. The RECIST criteria will be used to evaluate tumour response and disease progression at the time of the final volume determination.

Patients scheduled for unilobar SIRT will be consented for the study and enrolled into the study.

Liver volume will be measured at 3 time points.

CT volumetry will be performed at: 1) prior to treatment; 2) 4 to 6 weeks and 3) 8 to12 weeks after SIRT.

Administration of Y90 SIRT

This is based on our current institution practice. All patients would be reviewed with regards to suitability for Y90 SIRT and given appropriate counselling and advice regarding the angiographic procedures and the Y90 SIRT procedure, including potential side-effects. The patients undergo baseline blood investigations, typically liver function tests, renal function tests as well as full blood counts and coagulation profiles. All prior imaging CT and MRI were reviewed. Mapping hepatic angiography and 99mTc-MAA (micro-aggregated albumin) injection are performed according to standard technique. Prophylactic coil embolization of vessels at risk are performed either at mapping hepatic angiography or at 90Y radioembolization, at the discretion of the interventional radiologist. The catheter tip position for 99mTc-MAA injection is decided by consensus between the interventional radiologist and nuclear medicine physician during mapping hepatic angiography. 99mTc-MAA is slowly hand-injected through the indwelling catheter. Patients are subsequently immediately transferred to the gamma-camera suite for planar liver-to-lung shunt scintigraphy and SPECT/CT of the abdomen. Y90 microspheres treatment is planned by artery-specific SPECT/CT partition modelling as described in the literature.

All treatments are planned by a team of experienced nuclear medicine physicians. Y90 SIRT is performed using resin microspheres (SIR-Spheres; Sirtex Medical Ltd.) within 2 weeks of mapping hepatic angiography. Catheter tip placement is the same as that for the 99mTc-MAA injections. In accordance with our institutional protocol, all patients are observed overnight after treatment. They are discharged the following day after Bremsstrahlung planar scintigraphy of the lung and SPECT/CT of the abdomen were performed.

Measurement of liver volume

Liver volume will be measure at 3 time points. All patients will undergo CT volumetry at baseline, 4-6 weeks and 8-12 weeks after SIRT. Multiphasic dynamic contrast-enhanced hepatic CT scans are obtained with either a Dual Source CT (Siemens Medical) or Brilliance iCT (Philips Medical System). Scans will be obtained using a standard four phase liver protocol with a multidetector CT system with at least 64-channel detectors. Contrast medium is administered to the patients for acquisition of arterial-phase and portal-venous-phase and equilibrium CT images. The CT scanning parameters included collimation of 0.625-1.2mm. The reconstructed slice thickness for the scans are 0.8 - 1.5 mm and reconstruction intervals of 0.4 - 1 mm. Reconstructed CT slices have a matrix size of 512×512 pixels. The images are then measured using a commercially available 3D software (Vital's Vitrea Advanced CT Liver Oncology package) and manually corrected, reviewed and resected by a single senior radiologist to ensure consistency in following the same anatomical landmarks. The software allows saving of the work performed in order to allow reviewing and rechecking of the final measurements.

If the patients' pretreatment CT scans were performed at SGH or NCC, they need not undergo additional baseline CT scan and volumetry may be performed on these the existing imaging data. However, they will need to undergo a baseline CT scan if the pretreatment scan was performed outside the campus.

Subsequently, the patient's will need to undergo 2 follow-up CT scans at 4 to 6 weeks and 8 to 12 weeks after administration of SIRT.

Primary outcomes:

1. The change in volume of the contralateral liver volume from baseline
2. Change in volume of the ipsilateral liver from baseline
3. HCC tumor response or progression after treatment according to RECIST criteria.

Follow-up

Other than the 2 additional follow-up CT scans, patient's will undergo follow-up as per any regular non-study patient who was treated with SIRT.

Prospective Post Y90 Liver Hypertrophy

Prospective Study of Early Contra-lateral Liver Lobar Hypertrophy After Unilobar Y-90 Selective Internal Radiation Therapy (SIRT) in Patients With Hepatocellular Carcinoma (HCC)

Primary outcomes:

The rate of change in volume of the contralateral liver volume from baseline

Singapore General Hospital

Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach

Associating Liver Partition and Portal vein ligation for Staged hepatectomy

ALPPS

Eduardo de Santibañes, MD, PhD

The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by inducing a rapid and large FLR hypertrophy. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy. The aim of the present study was to assess the safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.

Complete resection of liver malignancies remains as the best treatment to offer the possibility of long-term survival or cure. At diagnosis, many patients have locally advanced disease that often precludes a curative resection. During the past two decades, a better assessment of resectability through modern imaging techniques along with new multimodal therapies and the introduction of modern chemotherapy regimens have allowed to increase the pool of candidates for surgical treatment in patients with locally advanced disease. The current principles for safe liver resections focus mainly on the liver parenchyma that remains after resection rather than the liver resected. In fact, one of the main conditioning factors of posthepatectomy liver failure (PHLF) is the amount and quality of future liver remnant (FLR). The induction of hypertrophy of healthy parenchyma using either portal vein embolization (PVE) or ligation (PVL), in the setting of 1-stage or 2-stage liver resections, is nowadays considered the standard of care for patients with locally advanced liver tumors and small FLR.2,5-8 However, the need for long intervals between interventions (6-12 weeks), results in resectability rates that rarely exceed 60-80%.

In 2012, Schnitbauer et al introduced a novel 2-stage technique that allowed tumor resection in 25 patients from 5 German centers with marginally resectable or primarily nonresectable disease by means of a rapid and large FLR hypertrophy. This technique was later popularized with the acronym ALPPS for "Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy". The promising preliminary results obtained with this new surgical proposal in terms of hypertrophy and the possibility of challenging the previous methods generated a pronounced reaction in the surgical community world-wide that has rarely been seen in the history of hepato-pancreato-biliary (HPB) surgery. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality. The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy.

Data for all patients undergoing 2-stage hepatectomies with the ALPPS approach at the HPB Surgery Section of the Hospital Italiano de Buenos Aires between June 2011 and April 2014 was analyzed on an intention to treat basis. Patient demographics, clinical characteristics (body mass index, anesthesiological risk score, Charlson comorbidity index, preoperative chemotherapy), tumor type, surgical details, FLR hypertrophy, postoperative liver function, postoperative complications, length of hospital stay and survival were analyzed.

Regarding the surgical procedure, during the first stage a complete tumor resection (clean-up) of the FLR is performed if bilateral disease was present, either trough anatomical or atypical resections. Subsequently, the portal vein of the diseased hemi-liver (DH) is divided and either total (up to the inferior vena cava) or partial (up to the middle hepatic vein) parenchymal transection using the Cavitron Ultrasonic Surgical Aspirator (CUSA; Valley Lab, Boulder, CO, USA) is carried out. At the end of the first stage, the DH is either wrapped in a plastic bag or a plastic sheath placed between the cut surfaces. Once volumetric CT analysis demonstrated enough FLR hypertrophy and provided the patient is in good condition, the second stage is carried out the next available operative day resecting the DH. The type of liver resections performed were defined using the Brisbane 2000 nomenclature.

ALPPS: Safety, Feasibility and Efficacy at a Single Center

Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center

Ocurrence of any postoperative complication or mortality considering the Dindo-Clavien classification of surgical complications

Percentage of patients that finally arrive to the 2nd stage of the ALPPS approach

Achievement of sufficient short-term hypertrophy of the future liver remnant (FLR). Sufficiency was defined as a FLR \>0.5% of body weight or \>25% of standardized total liver volume in case of healthy liver parenchyma, or \>0.8% and 40% in case of diseased parenchyma.

Disease free survival was the time that a patient remained alive and without evidence of disease from the second stage. Overall survival was the time from the first stage to patient death.

To identify clinical or operative risk factors of postoperative complications

To identify clinical or operative risk factors or a reduced kinetic growth rate of the future liver remnant (\<35 cc/day)

Hospital Italiano de Buenos Aires

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

Laparoscopic ALPPS

Shuguo Zheng

Shuguo Zheng, Professor

The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a single center. The validity, feasibility and limitations were assessed objectively through our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective and feasible.

Background: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published literature reported that the two stages of ALPPS are the conventional laparotomy surgery，Patients need to undergo the injury of two open operations in a short time. The incidence of postoperative complications and mortality rate is as high as 53% -73% and 12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure in a single center, with special emphasis in validity, feasibility and limitations.

Results:

Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, long-term curative effect and survival time were collected and analysed.

Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Post Y90 Liver Hypertrophy	NCT02783261	Hepatocellular ... Liver Hypertrop...	CT volumetric m...	21 Years - 99 Years	Singapore General Hospital
ALPPS: Safety, Feasibility and Efficacy at a Single Center	NCT02164292	Locally Advance...	ALPPS	18 Years - 85 Years	Hospital Italiano de Buenos Aires
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy	NCT02203409	Liver Tumor	Laparoscopic AL...	18 Years - 70 Years	Southwest Hospital, China
Prospective Post Y90 Liver Hypertrophy	NCT02783261	Hepatocellular ... Liver Hypertrop...	CT volumetric m...	21 Years - 99 Years	Singapore General Hospital
ALPPS: Safety, Feasibility and Efficacy at a Single Center	NCT02164292	Locally Advance...	ALPPS	18 Years - 85 Years	Hospital Italiano de Buenos Aires

Spots Global Cancer Trial Database for hypertrophy

Every month we try and update this database with for hypertrophy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hypertrophy

Every month we try and update this database with for hypertrophy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hypertrophy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.