NCT01842971

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2016

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

3.5 years

First QC Date

April 24, 2013

Last Update Submit

July 31, 2018

Conditions

Colorectal Cancer

Keywords

two stage hepatectomyliver metastasiscolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • overall mortality

    one year after the two stage hepatectomy

  • number of patient with hepatocellular insufficiency

    postoperative day 30

  • overall morbidity

    postoperative day 30

  • preoperative liver volumetry

    one week prior to the surgery

  • quality of life

    the day before the first stage surgery and the day before the second stage surgery

Study Arms (1)

two stage hepatectomy

EXPERIMENTAL

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

Interventions

two stage hepatectomyPROCEDURE
two stage hepatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens University Hospital

Amiens, 80054, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • jean marc regimbeau, MD, PhD

    Amiens University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2013

First Posted

April 30, 2013

Study Start

June 7, 2013

Primary Completion

December 13, 2016

Study Completion

December 13, 2016

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

FR(1)