Colorectal Liver MetastasisNCT02642978
Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases
A study testing RSRCLM and Open in people with Colorectal Liver Metastasis, run by Xu jianmin at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure. 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?
- RSRCLM and Open
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 1 Sep 2019
- 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
- Age ≥ 18 and ≤ 75 years;
- Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
- Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
- Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- Written informed consent for participation in the trial.
- The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.
Who cannot join
- Body mass index (BMI) more than 30 kg/m2.
- Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
- History of accepting abdominal surgery.
- Liver tumor located at I or invasive the middle hepatic vein.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, 200032
jianmin xu, professor, 008613501984869, xujmin@yahoo.com.cn
yunshi zhong, doctor, 008613564623481, zhong780124@sina.com
About this study
Official title: The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study
The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.
Read the detailed description
The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
- Conditions
- Colorectal Liver Metastasis
- Being tested
- RSRCLM, Open
- Keywords
- minimally invasive surgery, colorectal liver metastasis, robotic surgery, Patients with resectable colorectal liver metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSRCLMProcedure or surgery
The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
OpenProcedure or surgery
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis
| Study group | Role | What they receive |
|---|---|---|
| RSRCLM | Experimental | robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).Three different liver resection procedures were chose to personalized patients. Generally, when the size of liver metastasis was ≤ 3 cm, a wedge resection was chose without Hilar vessels blocking. The segmentectomy was performed using the Glissonian approach when tumor size was among 3-5 cm, and Hilar vessels was blocked, if necessary. For resection of Couinaud's segments II and III, left lateral sectionectomy (LLS) was performed commonly. Intraoperative ultrasound can help us find intrahepatic pedicles and follow the proper resection line. When liver tumor size was more than 5 cm or more than 3 tumors with the size over 3cm, hemicolectomy was applied usually. Receives: Procedure: RSRCLM |
| Open | Active comparator | Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated. Receives: Procedure: Open |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complication
According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery
Measured: 30 days after surgury
Secondary outcomes (4)
Operative mortality
death occurred 30 days after operation
Measured: 30 days post operatively
Disease-free survival(DFS)
DFS was defined as from the date of randomization to the date of tumor
Measured: 3 years disease-free survival
overall survival (OS)
overall survival was defined as from the date of randomization to the date of Death ;
Measured: OS rate at 3 and 5 years after operation
locoregional recurrence rate
local recurrence rate at 3 and 5 years after operation
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- micro-invasive surgery
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu jianmin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu jianmin, Fudan University
- Investigators
- wenju chang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642978
- Sponsor's protocol ID
- RSRCLM
- Status last verified
- Mar 2019
- First submitted
- 8 Sep 2015
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang W, Ye Q, Xu D, Liu Y, Zhou S, Ren L, He G, Zhou G, Liang F, Fan J, Wei Y, Wang X, Xu J. Robotic versus open surgery for simultaneous resection of rectal cancer and liver metastases: a randomized controlled trial. Int J Surg. 2023 Nov 1;109(11):3346-3353. doi: 10.1097/JS9.0000000000000581.
PubMed 37800563
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
- The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT02642978
- Acronym / sponsor ID
- RSRCLM
- Conditions
- Colorectal Liver Metastasis
- Keywords
- minimally invasive surgery, colorectal liver metastasis, robotic surgery, Patients with resectable colorectal liver metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xu jianminUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 30 Dec 2015 (estimated)
- 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.
The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.
Detailed description
The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- micro-invasive surgery
| Arm | Type | Receives |
|---|---|---|
| RSRCLM | Experimental | Procedure: RSRCLMrobot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).Three different liver resection procedures were chose to personalized patients. Generally, when the size of liver metastasis was ≤ 3 cm, a wedge resection was chose without Hilar vessels blocking. The segmentectomy was performed using the Glissonian approach when tumor size was among 3-5 cm, and Hilar vessels was blocked, if necessary. For resection of Couinaud's segments II and III, left lateral sectionectomy (LLS) was performed commonly. Intraoperative ultrasound can help us find intrahepatic pedicles and follow the proper resection line. When liver tumor size was more than 5 cm or more than 3 tumors with the size over 3cm, hemicolectomy was applied usually. |
| Open | Active comparator | Procedure: OpenTraditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 and ≤ 75 years;
- Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
- Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
Key exclusion criteria (4 listed)
- Body mass index (BMI) more than 30 kg/m2.
- Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
- History of accepting abdominal surgery.
- Liver tumor located at I or invasive the middle hepatic vein.
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 |
|---|---|---|
| RSRCLMThe Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM). | Procedure or surgery | RSRCLM |
| OpenTraditional open simultaneous radical resection of both colorectal cancer and liver metastasis | Procedure or surgery | Open |
Primary outcome
Surgical Complication
Time frame: 30 days after surgury
According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery
4 secondary outcomes
Operative mortality
Time frame: 30 days post operatively
Disease-free survival(DFS)
Time frame: 3 years disease-free survival
overall survival (OS)
Time frame: OS rate at 3 and 5 years after operation
locoregional recurrence rate
Time frame: 3 and 5 years
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.
- Derived from this study: PubMed 37800563Chang W, Ye Q, Xu D, Liu Y, Zhou S, Ren L, He G, Zhou G, Liang F, Fan J, Wei Y, Wang X, Xu J. Robotic versus open surgery for simultaneous resection of rectal cancer and liver metastases: a randomized controlled trial. Int J Surg. 2023 Nov 1;109(11):3346-3353. doi: 10.1097/JS9.0000000000000581.
- 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.
wenju chang, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSRCLM and Open 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 8 inclusion and 4 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?
Contact jianmin Xu, MD (008613501984869, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Complication (time frame: 30 days after surgury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642978, which also lists 1 linked publication.
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.