Study Purpose: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases.
Methods: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection.
Results: Not applicable.
Conclusion: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR.
Trial Registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).
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http://dx.doi.org/10.1007/s00270-022-03176-1 | DOI Listing |
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Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
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Gastroenterology and Hepatology, Barts Health NHS Trust, London, GBR.
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Department of Oral Biology, Sindh Institute of Oral Health Sciences, Jinnah Sindh Medical University, Karachi, Pakistan.
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December 2024
Fujian Key Laboratory of Sensing and Computing for Smart Cities, School of Informatics, Xiamen University, Xiamen, China.
Introduction: Ensuring effective measures against the spread of the virus is paramount for educational institutions and workplaces as they resume operations amidst the ongoing public health crisis. A touchless and privacy-conscious check-in procedure for visitor assessment is critical to safeguarding venues against potential virus transmission.
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Front Public Health
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Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
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