A Biodegradable Polymeric Sealant Applied to Transected Margin Following Stapled Distal Pancreatectomy Reduces Overall Complication: A Randomised Controlled Trial

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Abstract
Background: Postoperative pancreatic fistula (POPF) is the primary cause of morbidity after distal pancreatectomy (DP). This trial investigated the application of a combined polyethylene glycol (PEG) and recombinant human albumin sealant gel to the stapled, transected pancreatic margin to reduce clinically significant POPF. Methods: A multicenter randomised controlled trial in patient candidates for DP with stapled transection was conducted. Participants were randomised to receive DP with or without PEG sealant applied to the stapled margin. The primary outcome was clinically significant POPF. Secondary outcomes included other complications, length of hospital stay and 90‐day mortality. Results: Seventy‐eight patients with completed DP were included, 38 of whom underwent stapled DP combined with the use of PEG sealant (PEG group). No significant differences between the two groups were observed with respect to pathology type, operative approach or operative time. The PEG group exhibited significantly fewer complications (18% vs. 50% in the control group; p = 0.003), and a lower rate of POPF (11% vs. 28%; p = 0.08, respectively). Multivariate analysis revealed a significant association between spleen preservation and the rate of clinically significant fistula (OR 4.4; 95% CI 1.1–18.0; p = 0.038). The rate of POPF was lower in the PEG group but did not reach statistical significance (OR 0.3; 95% CI 0.1–1.2; p = 0.091). Conclusion: Stapled DP combined with PEG application was associated with reduced complications. There was a lower rate of POPF in the PEG sealant group that did not reach statistical significance. Australian New Zealand Clinical Trials Registry: ACTRN12620001336976p.

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