• Annals of surgery · Nov 2022

    Randomized Controlled Trial Multicenter Study

    Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula after Distal Pancreatectomy: Results of the REPLAY Multicenter Randomized clinical trial REPLAY: REinforcement of the Pancreas in distaL pAncreatectomY.

    • Aude Merdrignac, Jonathan Garnier, Safi Dokmak, Nicolas Regenet, Mickaël Lesurtel, Jean Yves Mabrut, Sa CunhaAntonioADepartment of Hepatic, Biliary, and Pancreatic Surgery, Paul Brousse HepatoBiliary Centre, INSERM U985, Villejuif, France., David Fuks, Damien Bergeat, Fabien Robin, Estelle Le Pabic, Karim Boudjema, Olivier Turrini, Bruno Laviolle, and Laurent Sulpice.
    • Department of Hepato-Biliary and Digestive Surgery, Rennes University Hospital France.
    • Ann. Surg. 2022 Nov 1; 276 (5): 769-775.

    ObjectiveThe aim of the study was to evaluate the impact of the use of a reinforced stapler (RS) during distal pancreatectomy (DP) on postoperative outcomes.BackgroundDP remains associated with significant postoperative morbidity owing to pancreatic fistula (PF). To date, there is no consensus on the management of the pancreatic stump. The use of an RS potentially represents a simple way to decrease the rate of PF.MethodsThe REPLAY study (NCT03030170) is a prospective, multicenter, randomized study. Patients who underwent DP were randomized (1:1 ratio) in 2 groups for the use of a standard stapler (SS) or an RS to close remnant pancreatic parenchyma. The primary endpoint was the rate of overall PF. Secondary endpoints included severity of PF, length of hospital stay, overall morbidity, and rate of readmission for a PF within 90 days. Participants were blinded to the procedure actually carried out.ResultsA total of 199 were analyzed (SS, n=99; RS, n=100). One patient who did not undergo surgery was excluded. Baseline characteristics were comparable in both groups. The rate of overall PF was higher in RS group (SS: 67.7%, RS: 83%, P =0.0121), but the rate of clinically relevant PF was similar (SS: 11.1%, RS: 14%, P =0.5387). Mean length of total hospital stay, readmission for PF, postoperative morbidity, and mortality at 90 days were similar.ConclusionThe results of this randomized clinical trial did not favor the use of RS during DP to reduce the rate of PF.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

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