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Original Investigation
September 16, 2020

Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial

Author Affiliations
  • 1Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France
  • 2Department of Imaging and Interventional Radiology, Nîmes University Hospital (CHU), Nîmes, France
  • 3Department of Imaging and Interventional Radiology, Montpellier University Hospital (CHU), Montpellier, France
  • 4Department of Vascular and General Surgery, Bordeaux University Hospital (CHU), Bordeaux, France
  • 5Department of Visceral Surgery, Angers University Hospital (CHU), Angers, France
  • 6Department of Anesthesia and Intensive Care, Lyon-Sud University Hospital (CHU), Pierre Bénite, France
  • 7Department of Imaging and Interventional Radiology, Nantes University Hospital (CHU), Nantes, France
  • 8Department of General, Digestive, Oncologic, Bariatric, and Metabolic Surgery, Avicenne University Hospital (CHU), Bobigny, France
  • 9Department of General and Oncologic Surgery, Nîmes University Hospital (CHU), Nîmes, France
  • 10Department of Imaging and Interventional Radiology, Grenoble-Alpes University Hospital (CHU), Grenoble, France
  • 11Department of Anesthesia and Intensive Care, Grenoble-Alpes University Hospital (CHU), Grenoble, France
  • 12Department of Medical Information, Grenoble-Alpes University Hospital (CHU), Grenoble, France
JAMA Surg. Published online September 16, 2020. doi:10.1001/jamasurg.2020.3672
Key Points

Question  For patients with blunt trauma at high risk of spleen rupture, does prophylactic splenic artery embolization improve the rate of spleen rescue compared with surveillance and embolization only if necessary?

Findings  In this randomized clinical trial, the number of patients with an at least 50% viable spleen detected on a computed tomography scan at 1 month was not significantly different between patients receiving immediate prophylactic splenic artery embolization and those receiving surveillance only, with embolization only if necessary. Many patients in the surveillance group received embolization within a few days and were hospitalized for significantly longer.

Meaning  For patients with severe splenic trauma, both strategies resulted in a spleen rescue rate greater than 93%.

Abstract

Importance  Splenic arterial embolization (SAE) improves the rate of spleen rescue, yet the advantage of prophylactic SAE (pSAE) compared with surveillance and then embolization only if necessary (SURV) for patients at high risk of spleen rupture remains controversial.

Objective  To determine whether the 1-month spleen salvage rate is better after pSAE or SURV.

Design, Setting, and Participants  In this randomized clinical trial conducted between February 6, 2014, and September 1, 2017, at 16 institutions in France, 133 patients with splenic trauma at high risk of rupture were randomized to undergo pSAE or SURV. All analyses were performed on a per-protocol basis, as well as an intention-to-treat analysis for specific events.

Interventions  Prophylactic SAE, preferably using an arterial approach via the femoral artery, or SURV.

Main Outcomes and Measures  The primary end point was an intact spleen or a spleen with at least 50% vascularized parenchyma detected on an arterial computed tomography scan at 1 month after trauma, assessed by senior radiologists masked to the treatment group. Secondary end points included splenectomy and pseudoaneurysm, secondary SAE after inclusion, complications, length of hospital stay, quality-of-life score, and length of time off work or studies during the 6-month follow-up.

Results  A total of 140 patients were randomized, and 133 (105 men [78.9%]; median age, 30 years [interquartile range, 23-47 years]) were retained in the study. For the primary end point, data from 117 patients (57 who underwent pSAE and 60 who underwent SURV) could be analyzed. The number of patients with at least a 50% viable spleen detected on a computed tomography scan at month 1 was not significantly different between the pSAE and SURV groups (56 of 57 [98.2%] vs 56 of 60 [93.3%]; difference, 4.9%; 95% CI, −2.4% to 12.1%; P = .37). By the day 5 visit, there were significantly fewer splenic pseudoaneurysms among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 8 of 65 [12.3%]; difference, −10.8%; 95% CI, −19.3% to −2.1%; P = .03), significantly fewer secondary embolizations among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 19 of 65 [29.2%]; difference, −27.7%; 95% CI, −41.0% to −15.9%; P < .001), and no difference in the overall complication rate between the pSAE and SURV groups (19 of 65 [29.2%] vs 27 of 65 [41.5%]; difference, −12.3%; 95% CI, −28.3% to 4.4%; P = .14). Between the day 5 and month 1 visits, the overall complication rate was not significantly different between the pSAE and SURV groups (11 of 59 [18.6%] vs 12 of 63 [19.0%]; difference, −0.4%; 95% CI, −14.4% to 13.6%; P = .96). The median length of hospitalization was significantly shorter for patients in the pSAE group than for those in the SURV group (9 days [interquartile range, 6-14 days] vs 13 days [interquartile range, 9-17 days]; P = .002).

Conclusions and Relevance  Among patients with splenic trauma at high risk of rupture, the 1-month spleen salvage rate was not statistically different between patients undergoing pSAE compared with those receiving SURV. In view of the high proportion of patients in the SURV group needing SAE, both strategies appear defendable.

Trial Registration  ClinicalTrials.gov Identifier: NCT02021396

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