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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01842971
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 42.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Procedure: two stage hepatectomy	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jun 7, 2013
• Actual Primary Completion Date: Dec 13, 2016
• Actual Study Completion Date: Dec 13, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of complete surgical procedure [postoperative week 4]

   the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.

Secondary Outcome Measures

1. overall mortality [one year after the two stage hepatectomy]

   the overall mortality is defined as the number of patients who are dead at one year after the surgery

2. number of patient with hepatocellular insufficiency [postoperative day 30]

   the hepatocellular insufficiency is defined by a prothrombin rate below 50%

3. overall morbidity [postoperative day 30]

   the overall morbidity is classified according to the Dindo Clavien classification

4. preoperative liver volumetry [one week prior to the surgery]

   the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist

5. quality of life [the day before the first stage surgery and the day before the second stage surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amiens University Hospital	Amiens		France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

• Principal Investigator: jean marc regimbeau, MD, PhD, Amiens University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT01842971
• Other Study ID Numbers: PI2012_843_0028; A41707-36
• First Posted: Apr 30, 2013
• Last Update Posted: Aug 2, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Centre Hospitalier Universitaire, Amiens: two stage hepatectomy; liver metastasis; colorectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis

Study Results

No Results Posted as of Aug 2, 2018