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

• ClinicalTrials.gov Identifier: NCT03895723
• Recruitment Status: Unknown
• First Posted: March 29, 2019
• Last Update Posted: March 29, 2019
• Sponsor: Xu jianmin
• Information provided by (Responsible Party): Xu jianmin, Fudan University

Tracking Information

• First Submitted Date: June 28, 2017
• First Posted Date: March 29, 2019
• Last Update Posted Date: March 29, 2019
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2019)

disease-free survival (DFS) [ Time Frame: 3 years disease-free survival ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 27, 2019)

• Overall survival (OS) [ Time Frame: 5 years overall survival ]
  OS was calculated from the date of liver resection to the date of death with any reason
• Sugical complications [ Time Frame: 1 months after sugery ]
  According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
• Official Title: Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
• Brief Summary: To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.
• Detailed Description: the minimally invasive procedure contain laparoscopic or robotic surgery
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm A: minimally invasive surgery Arm B: open

Masking: Single (Outcomes Assessor)
Masking Description:

The assessor was masking for patients treatment arms

Primary Purpose: Treatment

• Condition: Colorectal Liver Metastasis

Intervention

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

Study Arms

• Experimental: Minimally Invasive surgery
  the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection
  Intervention: Procedure: laparoscopic and robotic liver resection
• Open surgery
  the open surgery means traditional open surgery for liver resection
  Intervention: Procedure: open surgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 27, 2019): 220
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2024
• Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03895723
• Other Study ID Numbers: RSRCLM-02
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Xu jianmin, Fudan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Xu jianmin
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fudan University
• Verification Date: March 2019