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Spots Global Cancer Trial Database for Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer

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Trial Identification

Brief Title: 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 ID: NCT05116696

Study Description

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

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Clinical Center of Serbia, Belgrade, , Serbia

Contact Details

Name: Lazar Davidovic, MD PhD

Affiliation: Clinical Center of Serbia

Role: STUDY_CHAIR

Name: Petar M Zlatanovic, MD

Affiliation: Clinical Center of Serbia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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