Colorectal Liver MetastasisNCT03895723
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
A study testing laparoscopic and robotic liver resection and open surgery in people with Colorectal Liver Metastasis, run by Xu jianmin at 1 site in China.
Trial summary
To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Liver Metastasis
- What is being tested?
- laparoscopic and robotic liver resection and open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- liver metastases were unresectable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenju Chang
Shanghai, Shanghai Municipality, 200032
Wenju Chang, MD, +8613764476150, chang_erich@hotmail.com
About this study
Official title: Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.
Read the detailed description
the minimally invasive procedure contain laparoscopic or robotic surgery
- Conditions
- Colorectal Liver Metastasis
- Being tested
- laparoscopic and robotic liver resection, open surgery
- Keywords
- Colorectal liver metastasis, Minimally invasive surgery, Robotic surgery, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic and robotic liver resectionProcedure or surgery
laparoscopic and robotic procedure for liver resection
open surgeryProcedure or surgery
using open surgery procedure for liver resection
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive surgery | Experimental | the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection Receives: Procedure: laparoscopic and robotic liver resection |
| Open surgery | Other | the open surgery means traditional open surgery for liver resection Receives: Procedure: open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing
Measured: 3 years disease-free survival
Secondary outcomes (2)
Overall survival (OS)
OS was calculated from the date of liver resection to the date of death with any reason
Measured: 5 years overall survival
Sugical complications
According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery
Measured: 1 months after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A: minimally invasive surgery Arm B: open
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu jianmin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895723
- Sponsor's protocol ID
- RSRCLM-02
- Status last verified
- Mar 2019
- First submitted
- 28 Jun 2017
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT03895723
- Acronym / sponsor ID
- RSRCLM-02
- Conditions
- Colorectal Liver Metastasis
- Keywords
- Colorectal liver metastasis, Minimally invasive surgery, Robotic surgery, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xu jianminUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm A: minimally invasive surgery Arm B: open
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive surgery | Experimental | Procedure: laparoscopic and robotic liver resectionthe intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection |
| Open surgery | Other | Procedure: open surgerythe open surgery means traditional open surgery for liver resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- liver metastases were unresectable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic and robotic liver resectionlaparoscopic and robotic procedure for liver resection | Procedure or surgery | Minimally Invasive surgery |
| open surgeryusing open surgery procedure for liver resection | Procedure or surgery | Open surgery |
Primary outcome
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
2 secondary outcomes
Overall survival (OS)
Time frame: 5 years overall survival
Sugical complications
Time frame: 1 months after sugery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic and robotic liver resection and open surgery in people with Colorectal Liver Metastasis, run by Xu jianmin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: 3 years disease-free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.