ASSOCIATING LIVER PARTITION WITH PORTAL VEIN LIGATION FOR STAGED HEPATECTOMY (ALPPS) Versus Conventional Portal Vein Occlusion (PVO) for Resection of Liver Tumors Unresectable in One Step - a Randomized Controlled Trial
Inclusion criteria: •Patient may have primary or secondary hepatic malignancies with a
FLR/TLV < 30% or a FLR/BW ratio of < 0.5 for patients with normal liver function (defined
as normal transaminases, normal bilirubin, normal factor V, and normal PT/INR). In case of
injury due to chemotherapy, known high grade steatosis, or cholestasis > 50 mmol/L,
patient may be enrolled into the trial if FLR/TLV is < 40% or FLR/BW ratio < 0.8.
- Patient must have extensive liver tumors that would require portal vein embolization
or a two-stage hepatectomy and portal vein embolization or ligation by the judgment
of surgeons in the tumor board.
- Patient may have extrahepatic disease as long as it may be addressed after liver
surgery and there is a tumor board decision to proceed with liver resection (mostly
applicable to CRC metastases).
- Patient may have received previous chemotherapy.
- In cases of cholestasis, preoperative drainage procedures (PTC or ERCP) are left up
to judgement of physicians.
- Patient must be = 18 years of age. The patient population over 65 years old needs to
be carefully included based on comorbidities.
- Patient may have undergone previous liver resection.
- Patient's location must be such that proper staging and follow-up may be performed.
- Patient's case must be presented at the Multidisciplinary Meeting attended by
hepatobiliary surgeons, oncologists, hepatologists, and radiologists, or must be
approved directly by Dr. Strasberg or Dr. Chapman.
Exclusion criteria: •Patient must not have any significant concomitant diseases rendering
him/her unsuitable for major liver surgery by the judgment of the physicians involved,
especially if the patient is > 65 years old.
- Patient must not have enrolled into a clinical trial within 4 weeks of study entry.
- Patient must not have peritoneal carcinomatosis or other extensive extrahepatic
- Patient must not have advanced stages of carcinoma of the gallbladder (T3/T4)
- Patient must not have issues such as drug and/or alcohol abuse.
- Patient must not need major extrahepatic surgery (e.g. pancreas resection, gastric
resection, rectal surgery) within 3 months of study entry.
- Patient must not be a candidate for liver transplantation in case of HCC.
- Patient must not be pregnant or breastfeeding. If a female of childbearing potential,
patient must have a negative pregnancy test within 14 days of enrollment.