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Background: Studies indicate that patients can be "seeded" with their own cancer cells during oncologic surgery and that the immune response to these circulating cancer cells might influence the risk of cancer recurrence. Preliminary data from animal studies and some retrospective analyses suggest that anesthetic technique might affect the immune response during surgery and hence the risk of cancer recurrence. In 2015, experts called for prospective scientific inquiry into whether anesthetic technique used in cancer resection surgeries affects cancer-related outcomes such as recurrence and mortality. Therefore, we designed a pragmatic phase 3 multicenter randomized controlled trial (RCT) called General Anesthetics in Cancer Resection (GA-CARES).
Methods: After clinical trial registration and institutional review board approval, patients providing written informed consent were enrolled at five sites in New York (NY) State. Eligible patients were adults with known or suspected cancer undergoing one of eight oncologic surgeries having a high risk of cancer recurrence. Exclusion criteria included known or suspected history of malignant hyperthermia or hypersensitivity to either propofol or volatile anesthetic agents. Patients were randomized (1:1) stratified by center and surgery type using REDCap to receive either propofol or volatile agent for maintenance of general anesthesia (GA). This pragmatic trial, which seeks to assess the potential impact of anesthetic type in "real world practice", did not standardize any aspect of patient care. However, potential confounders, e.g., use of neuroaxial anesthesia, were recorded to confirm the balance between study arms. Assuming a 5% absolute difference in 2-year overall survival rates (85% vs 90%) between study arms (primary endpoint, minimum 2-year follow-up), power using a two-sided log-rank test with type I error of 0.05 (no planned interim analyses) was calculated to be 97.4% based on a target enrollment of 1800 subjects. Data sources include the National Death Index (gold standard for vital status in the USA), NY Cancer Registry, and electronic harvesting of data from electronic medical records (EMR), with minimal manual data abstraction/data entry.
Discussion: Enrollment has been completed (n = 1804) and the study is in the follow-up phase. This unfunded, pragmatic trial, uses a novel approach for data collection focusing on electronic sources.
Trial Registration: Registered (NCT03034096) on January 27, 2017, prior to consent of the first patient on January 31, 2017.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832634 | PMC |
http://dx.doi.org/10.1186/s13741-022-00290-z | DOI Listing |
BMC Gastroenterol
December 2024
Department of Radiology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Hunan Cancer Hospital, Central South University, No.283, Tongzipo Road, Changsha, Hunan, 410013, China.
Background: Although stage I gastric cancer (GC) presents a favorable survival rate, outcomes for patients experiencing recurrence remain poor. This research focuses on assessing the prognosis and identifying risk factors for stage I GC patients, further assessing the necessity of adjuvant chemotherapy (AC).
Methods: The study involved a retrospective analysis of 902 patients with stage I GC who received curative resection from November 2010 to December 2020.
Acta Med Okayama
December 2024
Department of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Tenosynovial giant cell tumor (TGCT) is a fibrous histiocytic tumor originating in the synovial membrane. While cervical TGCT may not be considered a common diagnosis preoperatively because it is relatively rare, it has a high recurrence rate and should be considered. Total resection is preferable, but it can be challenging due to the risk of damaging the vertebral artery.
View Article and Find Full Text PDFActa Med Okayama
December 2024
Department of Gastroenterological Surgery, Kochi Health Sciences Center.
Traumatic neuroma is an abnormal proliferation of injured nerves resulting from trauma or surgery. We present a case of traumatic neuroma arising in the cystic duct after cholecystectomy. A 66-year-old man was referred to our department due to a biliary tumor.
View Article and Find Full Text PDFActa Med Okayama
December 2024
Department of Radiology, Kawasaki Medical School.
Radiation-induced angiosarcoma (RIAS) is a rare, late adverse event of radiotherapy comprising approximately half of all radiation-induced sarcomas. It has a relatively short latency period and generally unfavorable prognosis. This study presents a case of RIAS that developed 5 years and 11 months after the completion of hypofractionated radiotherapy (42.
View Article and Find Full Text PDFJ Minim Access Surg
December 2024
Department of Surgery, Division of Colorectal Surgery, China Medical University Hsinchu Hospital, Zhubei City, Taiwan.
Introduction: Transvaginal natural orifice specimen extraction surgery (NOSES) is an innovative and feasible approach for left-sided colorectal resections in females. This study aimed to report our experience with transvaginal NOSES for left-sided laparoscopic colorectal resections.
Patients And Methods: We analysed data for all patients with transvaginal extraction performed for left-sided laparoscopic colorectal resections between 2011 and 2021 at a tertiary teaching hospital in Taiwan.
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