Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05116696
Other study ID # CltiCancer
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date October 15, 2021

Study information

Verified date November 2021
Source Clinical Centre of Serbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 836
Est. completion date October 15, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Serbia Clinical Center of Serbia Belgrade

Sponsors (1)

Lead Sponsor Collaborator
Clinical Centre of Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Short-term mortality 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 During the hospital stay (up to 30-days) and 30-day after the initial surgery
Secondary Hospital adverse event 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. During the patients hospital stay (up to 30-days)
See also
  Status Clinical Trial Phase
Completed NCT04444232 - Cancer Communication Within Hispanic Social Networks N/A
Recruiting NCT06233253 - Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy N/A
Recruiting NCT05799820 - QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC Phase 2
Recruiting NCT04666727 - Role of Diet on the Microbiome of the Digestive System
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Recruiting NCT02376452 - Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients Phase 2
Completed NCT02254486 - Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults Phase 3
Completed NCT01486251 - Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00704600 - Nelfinavir, a Phase I/Phase II Rectal Cancer Study Phase 1/Phase 2
Completed NCT00485316 - Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma Phase 3
Recruiting NCT05223036 - Testing Obeticholic Acid for Familial Adenomatous Polyposis Phase 2
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT05022511 - Three Birds With One Stone N/A
Completed NCT04607291 - Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening Phase 1
Not yet recruiting NCT03969784 - Microparticles in Peritoneal Carcinomatosis of Colorectal Origin N/A
Terminated NCT05291988 - A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2