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

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 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

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

Lazar Davidovic, MD PhD

Petar M Zlatanovic, MD

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.

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.

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

Comparison of Short- and Long Term Clinical Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer Liver Metastases

It will be made upon the reader's request

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

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

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.

Clinical Centre of Serbia

Principal Investigator

Liver Diseases

Liver Neoplasms

Neoplastic Processes

Single arm study: percutaneous or open irreversible electropration of CRLM

Percutaneous (CT-guided) or open (US-guided) irreversible electroporation of central colorectal liver metastasis.

Irreversible electroporation (IRE)

Martijn R Meijerink, MD, PhD

Krijn P van Lienden, MD, PhD

Arian R van Erkel, MD, PhD

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeastasis.

The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for resection or thermal ablation due to vicinity to vulnerable structures such as vessels and bile ducts. Other objectives are safety, feasibility (technical success) and imaging characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities in dianosing local site recurrence (LSR) or residual disease (RD).

29 patients with histologically confirmed colorectal carcinoma who present with unresectable and not thermally ablative CRLM\< 3.5cm suitable for IRE will undergo percutaneous or open irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious) adverse events are registered. One day post-IRE MRI is performed to assess technical success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or recurrent disease. Overall technique effectiveness is determined 1 year after treatment.

The investigators hypothesize that IRE for central CRLM will lead to good tumor control without causing severe complications.

Single arm prospective trial with predefined endpoint: accept indication if at least 50% of patients are alive without local tumor progression at 12 months following irreversible electroporation (IRE) treatment for centrally located colorectal cancer liver metastases (CRLM)

Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases

Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE) - a Phase II Clinical Trial (COLDFIRE-2 Study)

The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after the initail IRE procedure) of IRE for CRLM on cross-sectional imaging performed after respectively 6 weeks, and after 3, 6, 9 and 12 months. Research has shown that 95% of all recurrences after RFA of CRLM are diagnosed within one year after treatment. Therefore, one year follow-up will allow for accurate calculation of efficacy. Exact secondary efficacy rate may require follow-up longer than 12 months since this includes lesions that have been re-treated due to local site recurrence/local tumor residue (which will be individualized for each patient after re-treatment of LSR/LTR).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer	NCT05116696	Chronic Limb-Th... Colorectal Carc... Colorectal Carc...	For chronic lim...	-	Clinical Centre of Serbia
Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases	NCT02082782	Colorectal Live...	Irreversible el...	18 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for colorectal liver metastases (crlm)