NCT03895723

Brief Summary

To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 28, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

June 28, 2017

Last Update Submit

March 27, 2019

Conditions

Colorectal Liver Metastasis

Keywords

Colorectal liver metastasisMinimally invasive surgeryRobotic surgeryLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • disease-free survival (DFS)

    DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing

    3 years disease-free survival

Secondary Outcomes (2)

  • Overall survival (OS)

    5 years overall survival

  • Sugical complications

    1 months after sugery

Study Arms (2)

Minimally Invasive surgery

EXPERIMENTAL

the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection

Procedure: laparoscopic and robotic liver resection

Open surgery

OTHER

the open surgery means traditional open surgery for liver resection

Procedure: open surgery

Interventions

laparoscopic and robotic liver resectionPROCEDURE

laparoscopic and robotic procedure for liver resection

Minimally Invasive surgery
open surgeryPROCEDURE

using open surgery procedure for liver resection

Open surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients were diagnosed with colorectal cancer liver metastases
  • without extra-hepatic liver metastases
  • age were within 18-75 yeas
  • the numbers of metastases more than 3
  • the maximal tumor size of liver metastases more than 10 cm

You may not qualify if:

  • liver metastases were unresectable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenju Chang

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

LaparoscopyConversion to Open Surgery

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor was masking for patients treatment arms
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arm A: minimally invasive surgery Arm B: open
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of colorectal cancer center

Study Record Dates

First Submitted

June 28, 2017

First Posted

March 29, 2019

Study Start

March 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2024

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)