Colorectal Liver MetastasesNCT06779474
Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
An observational study of Colorectal Liver Metastases, run by Yanhong Deng at 1 site in China.
Trial summary
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- Laparoscopic ALPPS
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants are hospitalized at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
Who may be able to join
- Male or female subjects > 18 years < 75 of age.
- ECOG performance status 0-1.
- Histologically confirmed colorectal adenocarcinoma.
- Imaging (CT or MRI) or pathological confirmation of liver metastasis.
- Child-Pugh grade A liver function.
- FLR/sTLV (standardized total liver volume) < 30% (patients without underlying liver diseases)or < 40% (patients with liver diseases, such as hepatic steatosis, cirrhosis, or liver damage after chemotherapy).
- The indication of surgery is evaluated by a multidisciplinary team attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists.
Who cannot join
- Patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor.
- Patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon.
- Diagnosis of other malignant tumors within the past 5 years.
- Intention to become pregnant during the course of the study.
- Inability to comply with the study protocol.
- Previous enrollment in the current study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Weidong Pan, 86-13925032539, panwd@mail.sysu.edu.cn
About this study
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Laparoscopic ALPPS has recently been reported as a minimally invasive technique that reduces perioperative risks. This study aimed to assess the safety and feasibility of full laparoscopic ALPPS in patients with CRLM.
- Conditions
- Colorectal Liver Metastases
- Being tested
- Laparoscopic ALPPS
- Keywords
- Colorectal liver metastases, Associating liver partition and portal vein ligation for staged hepatectomy, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ALPPSProcedure or surgery
Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic ALPPS group | CRLM patients with insufficient future liver remnant who are performed laparoscopic associating liver partition with portal vein ligation for staged hepatectomy Receives: Procedure: Laparoscopic ALPPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Morbidity and mortality of laparoscopic ALPPS
Measured: within the first 90 days after the first stage of ALPPS
Secondary outcomes (3)
Resection rate
R0 resection rate of laparoscopic ALPPS
Measured: within the first 14 days after the second stage of ALPPS
Survival
follow-up after the surgery every 3 months, to evaluate recurrence, death, analysis 1-year, 3-year overall survival rates，disease-free survival rates and recurrence rate.
Measured: 3 years
Future liver remnant after surgery
Future liver remnant volume calculated 3 months after the stage 2 surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanhong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779474
- Sponsor's protocol ID
- 2022ZSLYEC-130
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
- ClinicalTrials.gov ID
- NCT06779474
- Acronym / sponsor ID
- 2022ZSLYEC-130
- Conditions
- Colorectal Liver Metastases
- Keywords
- Colorectal liver metastases, Associating liver partition and portal vein ligation for staged hepatectomy, Laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yanhong DengUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 16 Jan 2025 (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.
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Laparoscopic ALPPS has recently been reported as a minimally invasive technique that reduces perioperative risks. This study aimed to assess the safety and feasibility of full laparoscopic ALPPS in patients with CRLM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic ALPPS group | – | Procedure: Laparoscopic ALPPSCRLM patients with insufficient future liver remnant who are performed laparoscopic associating liver partition with portal vein ligation for staged hepatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are hospitalized at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
Key inclusion criteria (7 listed)
- Male or female subjects > 18 years < 75 of age.
- ECOG performance status 0-1.
- Histologically confirmed colorectal adenocarcinoma.
- Imaging (CT or MRI) or pathological confirmation of liver metastasis.
- Child-Pugh grade A liver function.
Key exclusion criteria (6 listed)
- Patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor.
- Patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon.
- Diagnosis of other malignant tumors within the past 5 years.
- Intention to become pregnant during the course of the study.
- Inability to comply with the study protocol.
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 ALPPSLaparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy | Procedure or surgery | Laparoscopic ALPPS group |
Primary outcome
Incidence of Adverse Events
Time frame: within the first 90 days after the first stage of ALPPS
Morbidity and mortality of laparoscopic ALPPS
3 secondary outcomes
Resection rate
Time frame: within the first 14 days after the second stage of ALPPS
Survival
Time frame: 3 years
Future liver remnant after surgery
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. Study protocol
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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.
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 Colorectal Liver Metastases, run by Yanhong Deng 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weidong Pan (86-13925032539, panwd@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: within the first 90 days after the first stage of ALPPS). 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 17 Apr 2025.