Hand Assisted Wrapping of the Pancreas after Distal Pancreatectomy (DP) with a New Sealing Patch. Postoperative Drainage Sampling Still Needed?

The incidence for clinically relevant postoperative pancreatic fistulas (CR-POPF) (type B and C pancreatic fistulas as defined by the ISGPF) in distal pancreatectomies is high. We developed a new biodegradable sealant patch to reduce POPF and to achieve bleeding control. 40 patients eligible to this european multicenter, single-arm, prospective study received a distal pancreatectomy. After resection, the remaining pancreas tail was wrapped in the sealant patch. The primary endpoint evaluated the incidence of POPF up to 30-days post-operatively. The secondary endpoints integrated the assessment of bleeding control and leak associated comorbidities as well as re-interventions and device usability. CR-POPF occurred in 7 of 40 patients (17.5%) up to postoperative day 30. Interestingly, all of the CR-POPF had a type B; there was no type C POPF observed. 12 patients had only a biochemical leak. The meaning of drainage sampling at postoperative day 3 and its prognostic value has yet to be determined. The worsening of a biochemical leak still represents an unexplored phenomenon. The risk factors of the clinical evolution to CR-POPF after DP were downgraded through this new sealing patch. The present study was able to demonstrate that the sealant patch is safe and efficient. The results indicated excellent adhesive properties reducing incidence and severity of CR-POPF. The application of the patch could be easily done through a mini laparotomy in laparoscopic procedures.