Clinical trial NCT05116696: Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer
Official title: Comparison of Short- and Long Term Clinical Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 836
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: All-cause mortality
timeFrame: up to 60 months
Secondary outcomes:
measure: Short-term mortality
timeFrame: During the hospital stay (up to 30-days) and 30-day after the initial surgery
measure: Hospital adverse event
timeFrame: During the patients hospital stay (up to 30-days)
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
Study officials:
affiliation: Clinical Center of Serbia
name: Lazar Davidovic, MD PhD
role: STUDY_CHAIR
affiliation: Clinical Center of Serbia
name: Petar M Zlatanovic, MD
role: PRINCIPAL_INVESTIGATOR
References: