Resectable Simultaneous Colorectal Cancer Liver MetastasisNCT06550700
The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery
An observational study of Resectable Simultaneous Colorectal Cancer Liver Metastasis, run by Changhai Hospital at 1 site in China.
Trial summary
Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resectable Simultaneous Colorectal Cancer Liver Metastasis
- What is being tested?
- laparoscopic hybrid surgery (LHS)
- Type of treatment
- Surgery or procedure
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 1 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study collected clinical data from patients who underwent simultaneous resection of colorectal cancer liver metastases at the Department of Colorectal Surgery in Changhai Hospital from January 2010 to June 2021.
Who may be able to join
- Liver metastasis was detected while the colorectal cancer was diagnosed.
- Both the primary lesions and liver metastases were confirmed by postoperative pathological examination.
- Clinical data is complete.
Who cannot join
- Patients with unresectable extrahepatic metastases.
- Patients with other malignant tumor diseases that have not been cured.
- Clinical and pathological data were missed or incomplete follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: The Outcomes of Simultaneous Resection for Colorectal Cancer Liver Metastases by Laparoscopic Hybrid Surgery Versus Totally Open Surgery: a Prospective Cohort Study
Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.
- Being tested
- laparoscopic hybrid surgery (LHS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hybrid surgery (LHS)Procedure or surgery
First performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic hybrid surgery (LHS) cohort | Routine colorectal surgery is performed first, followed by liver surgery. The LHS cohort first performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision. Receives: Procedure: laparoscopic hybrid surgery (LHS) | |
| totally open surgery (TOS) cohort | Routine colorectal surgery is performed first, followed by liver surgery. The blood vessel detachment, bowel detachment, the distal bowel of the tumor in the TOS cohort were accomplished by open surgery through the mid-abdominal incision approach. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term outcome: Operative time
Time taken for surgery
Measured: Within one week of the patient undergoing surgery
short-term outcome: Blood loss
Patient haemorrhage during surgery
Measured: Within one week of the patient undergoing surgery
short-term outcome: Time of liquid diet
Time for patients to eat fluids for the first time after surgery
Measured: Within one week of the patient undergoing surgery
short-term outcome: Postoperative hospital stay
Length of stay of patients after surgery
Measured: Within one week of the patient undergoing surgery
short-term outcome: Surgical complications
Complications that occur in patients after surgery
Measured: Within one week of the patient undergoing surgery
Secondary outcomes (2)
overall survival (OS)
the time after surgical treatment until death for any reason
Measured: 3years
disease-free survival (DFS)
the time after surgical treatment until the first observation of tumor recurrence or death for any reason
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2010
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Simultaneous Colorectal Cancer Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550700
- Sponsor's protocol ID
- CHLM
- Status last verified
- Apr 2025
- First submitted
- 19 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Simultaneous Resection for Colorectal Cancer Liver Metastases by Laparoscopic Hybrid Surgery Versus Totally Open Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06550700
- Acronym / sponsor ID
- CHLM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Aug 2024 (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.
Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic hybrid surgery (LHS) cohort | – | Procedure: laparoscopic hybrid surgery (LHS)Routine colorectal surgery is performed first, followed by liver surgery. The LHS cohort first performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision. |
| totally open surgery (TOS) cohort | – | –Routine colorectal surgery is performed first, followed by liver surgery. The blood vessel detachment, bowel detachment, the distal bowel of the tumor in the TOS cohort were accomplished by open surgery through the mid-abdominal incision approach. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study collected clinical data from patients who underwent simultaneous resection of colorectal cancer liver metastases at the Department of Colorectal Surgery in Changhai Hospital from January 2010 to June 2021.
Key inclusion criteria (3 listed)
- Liver metastasis was detected while the colorectal cancer was diagnosed.
- Both the primary lesions and liver metastases were confirmed by postoperative pathological examination.
- Clinical data is complete.
Key exclusion criteria (3 listed)
- Patients with unresectable extrahepatic metastases.
- Patients with other malignant tumor diseases that have not been cured.
- Clinical and pathological data were missed or incomplete follow-up data.
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 hybrid surgery (LHS)First performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision. | Procedure or surgery | laparoscopic hybrid surgery (LHS) cohort |
Primary outcome
short-term outcome: Operative time
Time frame: Within one week of the patient undergoing surgery
Time taken for surgery
short-term outcome: Blood loss
Time frame: Within one week of the patient undergoing surgery
Patient haemorrhage during surgery
short-term outcome: Time of liquid diet
Time frame: Within one week of the patient undergoing surgery
Time for patients to eat fluids for the first time after surgery
short-term outcome: Postoperative hospital stay
Time frame: Within one week of the patient undergoing surgery
Length of stay of patients after surgery
short-term outcome: Surgical complications
Time frame: Within one week of the patient undergoing surgery
Complications that occur in patients after surgery
2 secondary outcomes
overall survival (OS)
Time frame: 3years
disease-free survival (DFS)
Time frame: 3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Simultaneous Colorectal Cancer Liver Metastasis, run by Changhai Hospital 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term outcome: Operative time (time frame: Within one week of the patient undergoing surgery). The study lists 5 primary outcomes in all. 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 11 Apr 2025.