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Introduction: Anastomotic leakage is one of the most dangerous complications after rectal surgery. It can cause systemic complications, reduce the quality of life and worsen the results of oncological treatment. One of the causes of anastomotic leak is insufficient blood supply to the anastomosis. Intraoperative infrared angiography with indocyanine green (ICG) is expected to improve the assessment of intestinal perfusion and thus prevent anastomotic leakage. Aim: To present the results of the use of ICG intraoperative angiography during rectal surgery in the prevention of anastomotic leakage. Material and methods: The study included 76 patients undergoing rectal cancer surgery. Patients were randomized to 2 groups: Group I - 41 patients with ICG intraoperative angiography; and Group II - 35 patients without ICG imaging. Anastomotic leak, length of hospitalization, and complication rate were compared. Results: Group I patients received intravenous ICG before the anastomosis. Average time of intestinal wall contrasting was 42 s (22-65 s). Average ICG procedure time was 4 min (3.2% of total time of surgery). Three (7.3%) patients after angiography revealed intestinal ischemia requiring widened resection. No anastomotic leak was found post-operatively, and no side effects were observed after administration of ICG. In group II, 3 (8.6%) anastomotic leakages were diagnosed, 2 of which required reoperation. Conclusions: Intraoperative angiography with ICG in near-infrared light is a safe and effective method of assessing intestinal perfusion. ICG angiography may change the surgical plan and reduce the risk of anastomotic leakage. It is necessary to continue the study until the assumed number of patients is reached.
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BACKGROUND: Cancer continues to be the leading cause of mortality in high-income countries, necessitating the development of more precise and effective treatment modalities. Immunotherapy, specifically adoptive cell transfer of T cell receptor (TCR)-engineered T cells (TCR-T therapy), has shown promise in engaging the immune system for cancer treatment. One of the biggest challenges in the development of TCR-T therapies is the proper prediction of the pairing between TCRs and peptide-human leukocyte antigen (pHLAs). Modern computational immunology, using artificial intelligence (AI)-based platforms, provides the means to optimize the speed and accuracy of TCR screening and discovery. OBJECTIVE: This study proposes an observational clinical trial protocol to collect patient samples and generate a database of pHLA:TCR sequences to aid the development of an AI-based platform for efficient selection of specific TCRs. METHODS: The multicenter observational study, involving 8 participating hospitals, aims to enroll patients diagnosed with stage II, III, or IV colorectal cancer adenocarcinoma. RESULTS: Patient recruitment has recently been completed, with 100 participants enrolled. Primary tumor tissue and peripheral blood samples have been obtained, and peripheral blood mononuclear cells have been isolated and cryopreserved. Nucleic acid extraction (DNA and RNA) has been performed in 86 cases. Additionally, 57 samples underwent whole exome sequencing to determine the presence of somatic mutations and RNA sequencing for gene expression profiling. CONCLUSIONS: The results of this study may have a significant impact on the treatment of patients with colorectal cancer. The comprehensive database of pHLA:TCR sequences generated through this observational clinical trial will facilitate the development of the AI-based platform for TCR selection. The results obtained thus far demonstrate successful patient recruitment and sample collection, laying the foundation for further analysis and the development of an innovative tool to expedite and enhance TCR selection for precision cancer treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04994093; https://clinicaltrials.gov/ct2/show/NCT04994093. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45872.