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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

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


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.

- Patient must be able to understand and willing to sign a written informed consent
document.

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.

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this
trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Liver free of tumors

Outcome Description:

Assessed by two independent and blinded radiologists using dynamic MRI with liver specific contrast; proportion of patients in each treatment arm; incidence across two arms will be summarized using contingency tables and compared by 2-sample Chi-square test or Fisher's exact test.

Outcome Time Frame:

At 3 months

Safety Issue:

No

Principal Investigator

Steven Strasberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United Stated: Institutional Review Board

Study ID:

201209123

NCT ID:

NCT01722175

Start Date:

January 2013

Completion Date:

January 2019

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110