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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?
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.
For patients with severe splenic trauma, both strategies resulted in a spleen rescue rate greater than 93%.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02021396
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Accepted for Publication: May 9, 2020.
Corresponding Author: Catherine Arvieux, MD, PhD, Department of General and Digestive Surgery, CHU Grenoble Alpes, CS 10232, 38043 Grenoble Cedex 09, France (firstname.lastname@example.org).
Published Online: September 16, 2020. doi:10.1001/jamasurg.2020.3672
Author Contributions: Dr Arvieux had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Arvieux, Frandon, David, Lemoine, Bouzat, Bosson, Barbois, Thony.
Acquisition, analysis, or interpretation of data: Arvieux, Frandon, Tidadini, Monnin-Bares, Foote, Dubuisson, Lermite, Douane, Tresallet, Rodiere, Bosson, Vilotitch, Barbois, Thony.
Drafting of the manuscript: Arvieux, Frandon, Vilotitch.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Tidadini, Bosson, Vilotitch.
Obtained funding: Arvieux, Tidadini, Tresallet.
Administrative, technical, or material support: Tidadini, Monnin-Bares, Foote, Lermite, Tresallet, Lemoine, Bosson, Thony.
Supervision: Arvieux, Frandon, David, Bouzat, Bosson, Thony.
Conflict of Interest Disclosures: Dr Arvieux reported receiving grants from the French Ministry of Health, Hospital Clinical Research Program (PHRC) 2012, given to CHU Grenoble Alpes, during the conduct of the study. Dr David reported receiving personal fees from LFB Laboratory outside the submitted work. Dr Rodiere reported receiving grants from the French Ministry of Health, Hospital Clinical Research Program (PHRC) 2012, given to CHU Grenoble Alpes, during the conduct of the study. Dr Bouzat reported receiving grants from LFB Laboratory outside the submitted work. Dr Thony reported receiving grants from the French Ministry of Health, Hospital Clinical Research Program (PHRC) 2012, given to CHU Grenoble Alpes, during the conduct of the study. No other disclosures were reported.
Funding/Support: This study was supported by the French Ministry of Health, Hospital Clinical Research Program (PHRC) 2012.
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
The Splenic Arterial Embolization to Avoid Splenectomy (SPLASH) study group members: University Hospitals (CHU), Grenoble Alpes: Julio Abba, Myriam Coutard, Anne Ego, Julien Guelfi, Nicolas Huet, and Julien Picard; University Hospitals (CHU), Nîmes: Jean-Paul Bergi and Laurent Muller; University Hospitals (CHU), Bordeaux: Matthieu Biais and Yann Lebras; University Hospitals (CHU), Angers: Guillaume Bouhours, Antoine Bouvier, and Catherine Ridereau; University Hospitals (CHU), Lyon Sud: François Cotton, Guillaume Passot, Pierre-Jean Valette, and Eric Voiglio; University Hospitals (CHU), Montpellier: Jonathan Charbit and Françoise Guillon; University Hospitals (CHU), Nantes: Raphael Cinotti and Sylvie Metairie; University Hospitals (CHU), Pitié-Salpêtrière, Paris: Philippe Cluzel and Mathieu Raux; Regional University Hospital (CHRU), Lille, Toulon: Delphine Garrigue, Marc Haberlay, Jean-Robert Nzamushe, and Isabelle Plenier; Army Teaching Hospital (HIA), Sainte-Anne, Toulon: Charles Aarteaga, Tristan Monchal, and Bertrand Prunet; Hospitals (CH), Annecy-Genevois: Charles Daragon, Albrice Levrat, and Jean-Philippe Mestrallet; Hospitals (CH), Valence: Patrice Fernandez, Christophe Henry, and Thomas Martinilli; Army Teaching Hospital (HIA), Percy, Toulon: Jean Louis Daban, Emmanuel Hornez, Eric Meaudre, and Christophe Teriitehau; University Hospitals (CHU), Henri-Mondor, Créteil: Philippe Compagnon, Hassen Hentati, and Hicham Kobeiter; University Hospitals (CHU), Nord Marseille: Irchid Al-naasan, Thierry Bege, Katia Chaumoitre, Marc Leone, and Nathalie Lesavre; and Hospitals (CH), Chambéry: Marie Michoud, Melanie Terebus-loock, and Jean-Marc Thouret.
Disclaimer: This study’s contents are solely the responsibility of the authors.
Meeting Presentation: This paper was presented at the Journees Francophones de Radiologie Diagnostique et Interventionelle; October 14, 2019; Paris, France.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Jean-Francois Timsit, MD, PhD, University Hospital Bichat, assisted with the study design and was not compensated. Helene Sabbah, MSc, Myriam Coutard, MSc, and Marylaure Gavard, MSc, Grenoble Alpes University Hospital (CHU), assisted with regulatory procedures and study safety and were not compensated. Tiphaine Voliot, Medsharing, assisted with development of the electronic case report form and was compensated.
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