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Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer

NCT ID: NCT05116696

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

836 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-10-15

Brief Summary

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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

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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

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Chronic Limb-Threatening Ischemia Colorectal Carcinoma Colorectal Carcinoma Metastatic in the Liver

Keywords

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Peripheral Arterial Disease (PAD) Chronic Limb-Threatening Ischemia (CLTI) Colorectal Carcinoma (CRC) Colorectal Liver Metastases (CRLM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic limb-threatening ischemia (CLTI) group

All CLTI patients presenting with wound, ischemia, foot infection (WIfI) stage IV disease consecutively treated at one institution

For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery

Intervention Type PROCEDURE

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

Colorectal liver metastases (CRLM) group

All CRLM patients presenting with wound, ischemia, foot infection (WIfI) with stage IV disease consecutively treated at one institution

For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery

Intervention Type PROCEDURE

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

Interventions

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For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Centre of Serbia

OTHER

Sponsor Role lead

Responsible Party

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Petar Zlatanovic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lazar Davidovic, MD PhD

Role: STUDY_CHAIR

Clinical Center of Serbia

Petar M Zlatanovic, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Center of Serbia

Locations

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Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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CltiCancer

Identifier Type: -

Identifier Source: org_study_id