ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

This is an interventional treatment trial for Liver Tumors Not Resectable in One Surgical Procedure Read More

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 disease.
• 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.