Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer

Официальное название

The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection

Обзор

This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.

Подробное описание

The study hypothesis is that neoadjuvant therapy of colorectal cancer leads to endothelial dysfunction, reduced microvascular density, and tissue fibrosis, and therefore contributes to the occurrence of perioperative complications. The primary objective of the study is to assess the association between microvascular density and neoadjuvant therapy, identify differences in biomarkers and demographic factors between patients with neoadjuvant therapy and those without neoadjuvant therapy, and compare clinical outcomes between patients treated with neoadjuvant therapy and those who underwent surgery as initial treatment. Secondary objectives are to determine the association of microvascular density and fibrosis in surgical wound tissue with postoperative complications and wound healing complications, and identify differences in biomarkers between patients with and without perioperative complications.

The study was approved by the Ethics Committee of the Osijek Clinical Hospital Center.

The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy and 34 patients undergoing colorectal cancer surgery who did not receive neoadjuvant therapy but whose first-line treatment is surgery. During the surgery, a skin and subcutaneous tissue sample will be taken for pathohistological analysis of microvascular density and tissue fibrosis, allowing for a more detailed assessment of microvascular changes associated with perioperative complications. It is planned to follow the patient from the surgery until the end of hospitalization, and data on post-discharge complications will be tracked through the medical history in the Hospital Information System one month after discharge from the hospital.

Вмешательства

• Процедура Skin and subcutaneous tissue sampling for histopathological analysis
  During the operation, a sample of skin and subcutaneous tissue approximately 1 cm long and 2 mm wide will be taken from the surgical incision site. The sample will be taken from an area that has not previously been affected by radiotherapy and will not compromise patient safety. Histopathological analysis will be performed in the Clinical Department of Pathology and Forensic Medicine. The degree of fibrosis of the skin and subcutaneous tissue and the microvascular density of the skin tissue wil
• Процедура Blood sampling for laboratory analyses before and after surgery
  Before surgery, blood samples will be taken for laboratory analysis. The following parameters will be assessed: leukocytes, hemoglobin, hematocrit, platelets, prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, urea, creatinine, blood glucose, potassium, AST, ALT, GGT, CRP, albumin, cholinesterase, IL-6, von Willebrand factor, and endothelin-1. Laboratory findings will be monitored 16 hours after surgery (leukocytes, hemoglobin,

Первичные конечные точки

• Analysis of microvascular density [Срок оценки: Assessed on tissue samples collected during surgery]
• Degree of skin fibrosis [Срок оценки: Assessed on tissue samples collected during surgery]

Вторичные конечные точки (6)

• von Willebrand factor [Срок оценки: Once, before surgery]
• Intraoperative hemodynamics [Срок оценки: During surgery]
• Vasoactive drugs [Срок оценки: During surgery]
• Blood transfusion during surgery [Срок оценки: During surgery]
• Postoperative laboratory parameters [Срок оценки: 16 hours after surgery]
• Postoperative laboratory parameters - CRP [Срок оценки: 16 hours after surgery]

Критерии участия

Критерии включения

• Adults aged ≥18 years with histologically confirmed colorectal cancer
• Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)
• Ability to understand the study protocol and provide written informed consent.
• Both sexes
• ASA classification II or III
• Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group

Критерии исключения

• Age <18 years
• Patients who are not conscious, not oriented, or unable to provide informed consent
• Patients unable to understand the study protocol
• Emergency surgical cases
• Patients on chronic corticosteroid therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Хорватия · 1 центр

• KBC Osijek — Osijek

Публикации

• Elawa S, Fredriksson I, Steinvall I, Zotterman J, Farnebo S, Tesselaar E. Skin perfusion and oxygen saturation after mastectomy and radiation therapy in breast cancer patients. Breast. 2024 Jun;75:103704. doi: 10.1016/j.breast.2024.103704. Epub 2024 Mar 6. PMID 38460441
• Afolabi H, Salleh SM, Zakaria Z, Ch'ng ES, Mohd Nafi SN, Abdul Aziz AAB, Al-Mhanna SB, Wada Y, Abdulrahman AS. The Prediction of Survival Outcome and Prognosis Factor in Association with Comorbidity Status in Patients with Colorectal Cancer: A Research-Based Study. Healthcare (Basel). 2022 Sep 5;10(9):1693. doi: 10.3390/healthcare10091693. PMID 36141305
• Chen CC, Wu ML, Huang KC, Huang IP, Chung YL. The Effects of Neoadjuvant Treatment on the Tumor Microenvironment in Rectal Cancer: Implications for Immune Activation and Therapy Response. Clin Colorectal Cancer. 2020 Dec;19(4):e164-e180. doi: 10.1016/j.clcc.2020.04.002. Epub 2020 Apr 16. PMID 32387305
• Admasu FT, Dejenie TA, Ayehu GW, Zewde EA, Dessie G, Adugna DG, Enyew EF, Geto Z, Abebe EC. Evaluation of thromboembolic event, basic coagulation parameters, and associated factors in patients with colorectal cancer: a multicenter study. Front Oncol. 2023 May 2;13:1143122. doi: 10.3389/fonc.2023.1143122. eCollection 2023. PMID 37205202
• Lee S, Huh SJ, Oh SY, Koh MS, Kim SH, Lee JH, Han JY, Choi HJ, Kim SJ, Kim HJ. Clinical significance of coagulation factors in operable colorectal cancer. Oncol Lett. 2017 Jun;13(6):4669-4674. doi: 10.3892/ol.2017.6058. Epub 2017 Apr 20. PMID 28599468
• Gamboa AC, Lee RM, Turgeon MK, Varlamos C, Regenbogen SE, Hrebinko KA, Holder-Murray J, Wiseman JT, Ejaz A, Feng MP, Hawkins AT, Bauer P, Silviera M, Maithel SK, Balch GC. Impact of Postoperative Complications on Oncologic Outcomes After Rectal Cancer Surgery: An Analysis of the US Rectal Cancer Consortium. Ann Surg Oncol. 2021 Mar;28(3):1712-1721. doi: 10.1245/s10434-020-08976-8. Epub 2020 Sep 23 PMID 32968958
• Hanna DN, Hawkins AT. Colorectal: Management of Postoperative Complications in Colorectal Surgery. Surg Clin North Am. 2021 Oct;101(5):717-729. doi: 10.1016/j.suc.2021.05.016. Epub 2021 Jul 30. PMID 34537139

Идентификаторы

NCT: NCT07422974 · CRC-NEO-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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