Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

Colorectal Liver Metastasis Clinical Trial

Official title:

Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895723
• Other study ID #: RSRCLM-02
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

the minimally invasive procedure contain laparoscopic or robotic surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• liver metastases were unresectable.

Related Conditions & MeSH terms

• Colorectal Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• laparoscopic and robotic liver resection
laparoscopic and robotic procedure for liver resection
• open surgery
using open surgery procedure for liver resection

Locations

Country	Name	City	State
China	Wenju Chang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xu jianmin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	OS was calculated from the date of liver resection to the date of death with any reason	5 years overall survival
Secondary	Sugical complications	According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery	1 months after sugery