Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) Versus Portal Vein Occlusion (PVO) to Induce Liver Regeneration for Resection of Liver Tumors That Are Unresectable in One Step - a Randomized Controlled Trial
- 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.
- Patient must be able to understand and willing to sign a written informed consent
- 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.
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this