Associating Liver Partition With Portal Vein Ligation For Staged Hepatectomy (ALPPS) or Portal Vein Occlusion in Treating Patients With Liver Cancer

NCT01722175 | Withdrawn Phase 2

• 1 other identifier: 201209123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Liver free of tumors

  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.

  At 3 months

Secondary Outcomes (5)

• Overall survival

  Up to 3 years

• Disease-free survival

  Up to 3 years

• Incidence of complications

  3 months

• Liver volumetric change after step 1 of ALPPS or PVO

  8 weeks

• Liver synthetic and transport function

  3 months

Study Arms (2)

Arm I (ALPPS)

EXPERIMENTAL

Patients undergo Associating Liver Partition with Portal Vein Ligation (ALPPS) step 1 surgery on day 0 and step 2 surgery 7-14 days later, based on patient's liver size.

Procedure: ALPPS surgery

Arm II (PVO)

ACTIVE COMPARATOR

Patients undergo portal vein occlusion (PVO) step 1 on day 0 and step 2 surgery 6-8 weeks later, based on patient's liver size.

Procedure: PVO surgery

Interventions

ALPPS surgery PROCEDURE

Arm I (ALPPS)

PVO surgery PROCEDURE

Arm II (PVO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Steven Strasberg, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Primary Completion: April 1, 2016
• Study Completion: January 1, 2019
• Last Updated: July 22, 2014

Record last verified: 2014-07