Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.

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).

Percutaneous transluminal renal angioplasty (PTRA) and surgical revascularisation in renovascular disease--a retrospective comparison of results, complications, and mortality.

OBJECTIVE: To evaluate results, complications and mortality following percutaneous transluminal renal angioplasty (PTRA) and open surgical revascularisation for renovascular disease. METHODS: A retrospective evaluation of 381 renovascular patients (median age 64, range 9-99 years, 152 women) treated at Malmö University Hospital during 1987-1996. Two hundred and sixty-two (69%) of the patients were treated with PTRA, 106 (28%) with open revascularisation. RESULTS: Thirty-day mortality was 2% in the PTRA group and 9% after open surgery (p<0.001). There were no differences between groups concerning the number of re-do procedures, but first re-do was performed after seven (IQR 3-14) months in the PTRA group, and after 15 (IQR 10-44) months after open revascularisation (p<0.0001). After a median follow-up of 4 months (IQR 0-13) systolic and diastolic blood pressure (BP) had decreased (p<0.0001) in both groups. The number of antihypertensive drugs was reduced (p<0.0001) and S-creatinine levels were unchanged in both groups. Long-time survival assessed with log-rank analysis was better (p<0.01) in the PTRA group. The risk ratio for death with open revascularisation was 1.69 (p<0.01). CONCLUSIONS: In this retrospective comparison, PTRA was as effective as open revascularisation, with lower complication rate and lower early and long-time mortality, but with shorter time to first re-do.