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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Tumors Not Resectable in One Surgical Procedure

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

Outcome Time Frame:

2012 to 2015

Safety Issue:

No

Principal Investigator

Erik Schadde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Visceral and Transplant Surgery

Authority:

Switzerland: Swissmedic

Study ID:

USZ-ZH-VIS-ALPPS

NCT ID:

NCT01775267

Start Date:

November 2012

Completion Date:

November 2015

Related Keywords:

  • Liver Tumors Not Resectable in One Surgical Procedure
  • Liver Neoplasms

Name

Location

Washington University St. Louis, Missouri  63110