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

NCT05116696 | Completed DMC

• 1 other identifier: CltiCancer
• Study Type: observational
• Target: 836
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

  up to 60 months

Secondary Outcomes (2)

• Short-term mortality

  During the hospital stay (up to 30-days) and 30-day after the initial surgery

• Hospital adverse event

  During the patients hospital stay (up to 30-days)

Study Arms (2)

Chronic limb-threatening ischemia (CLTI) group

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

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

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

Interventions

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

Chronic limb-threatening ischemia (CLTI) group; Colorectal liver metastases (CRLM) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Colorectal Neoplasms; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lazar Davidovic, MD PhD

  Clinical Center of Serbia

  STUDY CHAIR

• Petar M Zlatanovic, MD

  Clinical Center of Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 11, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 15, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

SE (1)