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

TerminadoFase 2ClinicalTrials.gov

ID: NCT01775267Tipo: INTERVENTIONALInicio: 1 de nov de 2012Fin estimado: 1 de nov de 2015

Traducción no disponible, mostrando original

Resumen

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. * Trial with surgical intervention

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

procedure

Associating liver partition and portal vein ligation for staged hepatectomy

procedure

Portal vein embolization or ligation

Ubicaciones

Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit

Buenos Aires, Argentina

Patrocinadores

PrincipalUniversity of Zurich

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