ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis

Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods

The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: two stage hepatectomy

Detailed Description

In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.

In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.

An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Amiens university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• potentially resectable liver metastasis from colorectal cancer
• portal embolisation required
• older than 18 years old

Exclusion Criteria:

• synchronous surgery on the colon or the rectum
• extra hepatic metastasis
• history of hepatectomy
• pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: two stage hepatectomy; the two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy	Procedure: two stage hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of complete surgical procedure	the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.	postoperative week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall mortality	the overall mortality is defined as the number of patients who are dead at one year after the surgery	one year after the two stage hepatectomy
number of patient with hepatocellular insufficiency	the hepatocellular insufficiency is defined by a prothrombin rate below 50%	postoperative day 30
overall morbidity	the overall morbidity is classified according to the Dindo Clavien classification	postoperative day 30
preoperative liver volumetry	the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist	one week prior to the surgery
quality of life	the quality of life is evaluated thanks to the EORTC QLQ C30 LMC 21 form the day before the first stage surgery and the day before the second stage surgery.	the day before the first stage surgery and the day before the second stage surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: jean marc regimbeau, MD, PhD, Amiens university hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2013
• Primary Completion (Actual): December 13, 2016
• Study Completion (Actual): December 13, 2016

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: colorectal cancer; liver metastasis; two stage hepatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: PI2012_843_0028; A41707-36 (Other Identifier: french ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No