Recurrence-free survival after curative resection of non-small cell lung cancer between inhalational gas anesthesia and propofol-based total intravenous anesthesia: a multicenter, randomized, clinical trial (GAS TIVA trial): protocol description
- 주제(키워드) Anesthesia , Desflurane , Inhalational anesthesia , Isoflurane , Lung Neoplasm , Metastasis , Non-small cell lung cancer , Propofol , Recurrence , Sevoflurane , Surgery
- 주제(기타) Anesthesiology; Surgery
- 설명문(일반) [Kim, Jeayoun; Ahn, Hyun Joo] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Yoon, Susie] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Song, In-Kyung] Univ Ulsan, Coll Med, Dept Anesthesiol & Pain Med, Lab Cardiovasc Dynam,Asan Med Ctr, Seoul, South Korea; [Lee, Kyuho] Yonsei Univ, Severance Hosp, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Hwang, Wonjung] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Kim, Heezoo] Korea Univ, Guro Hosp, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Lee, Dong Kyu] Dongguk Univ, Ilsan Hosp, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Lim, Hyun Kyoung] Inha Univ Hosp, Dept Anesthesiol & Pain Med, Incheon, South Korea; [Kim, Seong-Hyop] Konkuk Univ, Med Ctr, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Lee, Jong Wha] Ewha Womans Univ, Med Ctr, Coll Med, Dept Anesthesiol & Pain Med, Seoul, South Korea; [Hong, Boohwi] Chungnam Natl Univ, Chungnam Natl Univ Hosp, Coll Med, Dept Anesthesiol & Pain Med, Daejeon, South Korea; [Blank, Randal S.] Univ Virginia Hlth Syst, Dept Anesthesiol, Charlottesville, VA USA; [Pedoto, Alessia] Mem Sloan Kettering Canc Ctr, Dept Anesthesiol & Pain Med, New York, NY USA; [Popescu, Wanda] Yale Sch Med, Dept Anesthesiol & Pain Med, New Haven, CT USA; [Theresa, Glezinis] Univ Pittsburgh, Sch Med, Dept Anesthesiol & Perioperat Med, Pittsburgh, PA USA; [Martin, Archer Kilbourne] Mayo Clin, Dept Anesthesiol & Pain Med, Jacksonville, FL USA; [Patteril, Mathew] Univ Hosp Coventry & Warwickshire, Dept Anesthesia & Pain Med, Coventry, England; [Patteril, Mathew] Warwick Med Sch, Coventry, England; [Pathanasethpong, Atipong] Khon Kaen Univ, Dept Anesthesiol & Pain Med, Khon Kaen, Thailand; [Thongsuk, Yada; Pisitpitayasaree, Tanatporn] Chulalongkorn Univ, King Chulalongkorn Mem Hosp, Fac Med, Dept Anesthesiol, Bangkok, Thailand; [Huang, Aijie] Qingdao Univ, Yuhuangding Hosp, Dept Anesthesia & Pain Med, Qingdao, Shandong, Peoples R China; [Yu, Hui] Chinese Acad Med Sci, Beijing Hosp, Inst Geriatr Med, Natl Ctr Gerontol,Dept Anesthesiol, Beijing, Peoples R China; [Kapoor, Poonam Malhotra] All India Inst Med Sci, Dept Anesthesia & Crit Care, New Delhi, India; [Kim, Kyunga; Chi, Sang Ah] Samsung Med Ctr, Data Sci Res Inst, Res Inst Future Med, Biomed Stat Ctr, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Gold Open Access
- 발행기관 BMC
- 발행년도 2024
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000240626
- 본문언어 영어
- Published As https://doi.org/10.1186/s13741-024-00436-1
- PubMed https://pubmed.ncbi.nlm.nih.gov/39039548
초록/요약
BackgroundSurgery is the primary treatment for non-small cell lung cancer (NSCLC), but microscopic residual disease may be unavoidable. Preclinical studies have shown that volatile anesthetics might suppress host immunity and promote a pro-malignant environment that supports cancer cell proliferation, migration, and angiogenesis, whereas propofol may preserve cell-mediated immunity and inhibit tumor angiogenesis. However, clinical evidence that propofol-based total intravenous anesthesia (TIVA) can reduce tumor recurrence after curative resection remains inconsistent due to the retrospective observational nature of previous studies. Therefore, we will test the hypothesis that the recurrence-free survival (RFS) after curative resection of NSCLC is higher in patients who received TIVA than volatile anesthetics (GAS) in this multicenter randomized trial.MethodsThis double-blind, randomized trial will enroll patients at 22 international sites, subject to study registration, institutional review board approval, and patient written informed consent. Eligible patients are adult patients undergoing lung resection surgery with curative intent for NSCLC. Exclusion criteria will be contraindications to study drugs, American Society of Anesthesiologists physical status IV or higher, or preexisting distant metastasis or malignant tumor in other organs. At each study site, enrolled subjects will be randomly allocated into the TIVA and GAS groups with a 1:1 ratio. This pragmatic trial does not standardize any aspect of patient care. However, potential confounders will be balanced between the study arms. The primary outcome will be RFS. Secondary outcomes will be overall survival and complications within postoperative 7 days. Enrollment of 5384 patients will provide 80% power to detect a 3% treatment effect (hazard ratio of 0.83) at alpha 0.05 for RFS at 3 years.DiscussionConfirmation of the study hypothesis would demonstrate that a relatively minor and low-cost alteration in anesthetic management has the potential to reduce cancer recurrence risk in NSCLC, an ultimately fatal complication. Rejection of the hypothesis would end the ongoing debate about the relationship between cancer recurrence and anesthetic management.Trial registrationThe study protocol was prospectively registered at the Clinical trials (https://clinicaltrials.gov, NCT06330038, principal investigator: Hyun Joo Ahn; date of first public release: March 25, 2024) before the recruitment of the first participant.
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