Chronic Limb-Threatening IschemiaNCT05116696
Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer
An observational study of Chronic Limb-Threatening Ischemia and Colorectal Carcinoma, run by Clinical Centre of Serbia at 1 site in Serbia.
Trial summary
Colorectal cancer (CRC) and chronic limb-threatening ischemia (CLTI) are relatively frequent and potentially fatal diseases. However, studies that are comparing clinical outcomes between CRC and CLTI patients in more advanced stages of the disease are lacking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Limb-Threatening Ischemia, Colorectal Carcinoma, Colorectal Carcinoma Metastatic in the Liver
- What is being tested?
- For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 836 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Mar 2021to 15 Oct 2021
- 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: * Chronic limb-threatening (CLTI)group - patients presenting with wound, ischemia, infection (WIfI) stage IV disease undergoing some revascularization procedure (endovascular, open surgery hybrid) * All colorectal carcinoma (CRC) patients undergoing colorectal liver metastasis (CRLM) curative surgery
Who may be able to join
- All chronic limb-threatening (CLTI) patients presenting with wound, ischemia, infection (WIfI) stage IV disease undergoing some revascularization procedure (endovascular, open surgery hybrid).
- All colorectal carcinoma (CRC) patients undergoing colorectal liver metastasis (CRLM) surgery
Who cannot join
- For CLTI group: patients who did not undergo revascularization surgery, those who underwent primary major amputation, patients with lower stages of the disease (stage I, II, and III), patients who had acute lower limb ischemia
- For the CRLM group we excluded patients who did not undergo curative surgery, those who underwent liver resection due to other malignancies (hepatocellular carcinoma, cholangiocarcinoma, etc.), patients who underwent palliative surgery, liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short- and Long Term Clinical Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer Liver Metastases
Colorectal cancer (CRC) and chronic limb-threatening ischemia (CLTI) are relatively frequent and potentially fatal diseases. However, studies that are comparing clinical outcomes between CRC and CLTI patients in more advanced stages of the disease are lacking. The study aim was to evaluate outcomes of patients with colorectal cancer liver metastases (CRLM) treated by curative-intent liver resection and CLTI patients according to wound, ischemia, foot infection (WIfI) classification by comparing the short- and long-term clinical outcomes.
Read the detailed description
Peripheral arterial disease (PAD) is characterized by a global pandemic of growing proportions. In 2016, The Global Burden of Disease study reported that 202 million adults worldwide have PAD, with a higher prevalence compared to ischaemic heart disease (154 million), Alzheimer's disease (64 million) and cancer (43 million). The patient prognosis after PAD occurrence is poor because the disease often progresses to chronic limb-threatening ischemia (CLTI) that is an end-stage disease.
The 5-year mortality risk in CLTI patients is about 60%. When the mortality risk of CLTI is compared to mortality rates of the most common malignant diseases only six of them have a higher 5-year mortality rate compared to CLTI. One of them is colorectal cancer (CRC). CRC is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women.
According to the latest CLTI treatment guidelines, the Society for Vascular Surgery (SVS) WIfI (wound, infection, ischemia) classification should be employed to stage limb condition in patients with CLTI that is analog to the use of tumor, nodes, metastases (TNM) cancer staging system. Recent data indicate that WIfI appears to correlate strongly with important clinical outcomes.
The annual incidence of CLTI is greater than the incidence of cancers characterized by high mortality rates (esophageal, stomach, brain and ovarian). In addition, more people die from CLTI each year compared to death rates of the already mentioned cancers. However, studies that are comparing clinical outcomes between cancer and CLTI patients in more advanced stages of the disease are lacking.
The study aim was to evaluate outcomes of the wound, ischemia, foot infection (WIfI) stage IV CLTI and colorectal cancer liver metastases (CRLM) patients managed by curative-intent liver resection by comparing the short- and long-term clinical outcomes.
- Conditions
- Chronic Limb-Threatening Ischemia, Colorectal Carcinoma, Colorectal Carcinoma Metastatic in the Liver
- Being tested
- For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery
- Keywords
- Peripheral Arterial Disease (PAD), Chronic Limb-Threatening Ischemia (CLTI), Colorectal Carcinoma (CRC), Colorectal Liver Metastases (CRLM)
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Colorectal Neoplasms, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgeryProcedure or surgery
For chronic limb-threatening ischemia (CLTI) patients that represents one of the revascularisation methods (endovascular, open surgery, hybrid).
For the colorectal liver metastasis (CRLM) patients that represents liver resection with adjuvant chemo- or radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chronic limb-threatening ischemia (CLTI) group | All CLTI patients presenting with wound, ischemia, foot infection (WIfI) stage IV disease consecutively treated at one institution Receives: Procedure: For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery | |
| Colorectal liver metastases (CRLM) group | All CRLM patients presenting with wound, ischemia, foot infection (WIfI) with stage IV disease consecutively treated at one institution Receives: Procedure: For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Number of participants who died from all causes of death in both chronic limb-threatening ischemia (CLTI) and colorectal liver metastasis (CLRM) population in a given time period
Measured: up to 60 months
Secondary outcomes (2)
Short-term mortality
Number of participants for both chronic limb-threatening ischemia (CLTI) and colorectal liver metastasis (CLRM) population who died in hospital, as well as 30 days after the initial surgery
Measured: During the hospital stay (up to 30-days) and 30-day after the initial surgery
Hospital adverse event
Number of participants with the following postoperative adverse events: cardiac (acute coronary syndrome, heart failure, pulmonary embolism), pulmonary (intubation lasting longer than 72h, pneumonia, atelectasis requiring active treatment), hemodialysis, wound infection, postoperative surgical bleeding, red blood cell transfusion rate, hepatic insufficiency, biliary fistula, major amputation.
Measured: During the patients hospital stay (up to 30-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies 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
- Retrospective
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Zlatanovic, Clinical Centre of Serbia
- Investigators
- Lazar Davidovic, MD PhD, Study chair, Clinical Center of SerbiaPetar M Zlatanovic, MD, Principal investigator, Clinical Center of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116696
- Sponsor's protocol ID
- CltiCancer
- Status last verified
- Nov 2021
- First submitted
- 27 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be made upon the reader's request
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short- and Long Term Clinical Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT05116696
- Acronym / sponsor ID
- CltiCancer
- Conditions
- Chronic Limb-Threatening Ischemia, Colorectal Carcinoma, Colorectal Carcinoma Metastatic in the Liver
- Keywords
- Peripheral Arterial Disease (PAD), Chronic Limb-Threatening Ischemia (CLTI), Colorectal Carcinoma (CRC), Colorectal Liver Metastases (CRLM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 836 participants (actual)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Nov 2021 (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.
Colorectal cancer (CRC) and chronic limb-threatening ischemia (CLTI) are relatively frequent and potentially fatal diseases. However, studies that are comparing clinical outcomes between CRC and CLTI patients in more advanced stages of the disease are lacking. The study aim was to evaluate outcomes of patients with colorectal cancer liver metastases (CRLM) treated by curative-intent liver resection and CLTI patients according to wound, ischemia, foot infection (WIfI) classification by comparing the short- and long-term clinical outcomes.
Detailed description
Peripheral arterial disease (PAD) is characterized by a global pandemic of growing proportions. In 2016, The Global Burden of Disease study reported that 202 million adults worldwide have PAD, with a higher prevalence compared to ischaemic heart disease (154 million), Alzheimer's disease (64 million) and cancer (43 million). The patient prognosis after PAD occurrence is poor because the disease often progresses to chronic limb-threatening ischemia (CLTI) that is an end-stage disease.
The 5-year mortality risk in CLTI patients is about 60%. When the mortality risk of CLTI is compared to mortality rates of the most common malignant diseases only six of them have a higher 5-year mortality rate compared to CLTI. One of them is colorectal cancer (CRC). CRC is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women.
According to the latest CLTI treatment guidelines, the Society for Vascular Surgery (SVS) WIfI (wound, infection, ischemia) classification should be employed to stage limb condition in patients with CLTI that is analog to the use of tumor, nodes, metastases (TNM) cancer staging system. Recent data indicate that WIfI appears to correlate strongly with important clinical outcomes.
The annual incidence of CLTI is greater than the incidence of cancers characterized by high mortality rates (esophageal, stomach, brain and ovarian). In addition, more people die from CLTI each year compared to death rates of the already mentioned cancers. However, studies that are comparing clinical outcomes between cancer and CLTI patients in more advanced stages of the disease are lacking.
The study aim was to evaluate outcomes of the wound, ischemia, foot infection (WIfI) stage IV CLTI and colorectal cancer liver metastases (CRLM) patients managed by curative-intent liver resection by comparing the short- and long-term clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic limb-threatening ischemia (CLTI) group | – | Procedure: For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgeryAll CLTI patients presenting with wound, ischemia, foot infection (WIfI) stage IV disease consecutively treated at one institution |
| Colorectal liver metastases (CRLM) group | – | Procedure: For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgeryAll CRLM patients presenting with wound, ischemia, foot infection (WIfI) with stage IV disease consecutively treated at one institution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Chronic limb-threatening (CLTI)group - patients presenting with wound, ischemia, infection (WIfI) stage IV disease undergoing some revascularization procedure (endovascular, open surgery hybrid) * All colorectal carcinoma (CRC) patients undergoing colorectal liver metastasis (CRLM) curative surgery
Key inclusion criteria (2 listed)
- All chronic limb-threatening (CLTI) patients presenting with wound, ischemia, infection (WIfI) stage IV disease undergoing some revascularization procedure (endovascular, open surgery hybrid).
- All colorectal carcinoma (CRC) patients undergoing colorectal liver metastasis (CRLM) surgery
Key exclusion criteria (2 listed)
- For CLTI group: patients who did not undergo revascularization surgery, those who underwent primary major amputation, patients with lower stages of the disease (stage I, II, and III), patients who had acute lower limb ischemia
- For the CRLM group we excluded patients who did not undergo curative surgery, those who underwent liver resection due to other malignancies (hepatocellular carcinoma, cholangiocarcinoma, etc.), patients who underwent palliative surgery, liver transplantation
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 |
|---|---|---|
| For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgeryFor chronic limb-threatening ischemia (CLTI) patients that represents one of the revascularisation methods (endovascular, open surgery, hybrid). For the colorectal liver metastasis (CRLM) patients that represents liver resection with adjuvant chemo- or radiotherapy | Procedure or surgery | Chronic limb-threatening ischemia (CLTI) group, Colorectal liver metastases (CRLM) group |
Primary outcome
All-cause mortality
Time frame: up to 60 months
Number of participants who died from all causes of death in both chronic limb-threatening ischemia (CLTI) and colorectal liver metastasis (CLRM) population in a given time period
2 secondary outcomes
Short-term mortality
Time frame: During the hospital stay (up to 30-days) and 30-day after the initial surgery
Hospital adverse event
Time frame: During the patients hospital stay (up to 30-days)
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 Nov 2021.
- Individual participant dataSharing planned: Undecided. It will be made upon the reader's request
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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.
Lazar Davidovic, MD PhD study chair
Clinical Center of Serbia
Petar M Zlatanovic, MD principal investigator
Clinical Center of Serbia
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 Chronic Limb-Threatening Ischemia and Colorectal Carcinoma, run by Clinical Centre of Serbia at 1 site in Serbia.
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 2 inclusion and 2 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 Nov 2021. 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 Serbia. 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?
All-cause mortality (time frame: up to 60 months). 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 Nov 2021.