Use of Hemopatch as a Sealant at the Pancreatojejunostomy to Prevent Postoperative Pancreatic Fistula: A Randomized Controlled Trial

Purpose: Postoperative pancreatic fistula (POPF) remains the most severe complication following pancreatoduodenectomy (PD) (9.8% to 34.2%). POPF not only prolongs hospital stay and increases healthcare costs, but also plays a central role in the development of life-threatening events such as intra-abdominal abscess and postoperative hemorrhage. Modification of reconstruction techniques, somatostatin and analogues, pancreatic stents, and sealants have been used to decrease POPF rate. In this study, we reinforced the duct-to-mucosa pancreatojejunostomy with a PEG-coated collagen patch. The objective was to determine the effect of the sealant Hemopatch on the decrease of the clinically relevant (grade B and C) POPF as defined by ISGPS. Method: A randomized controlled trial (NCT03419676) including 64 consecutive PD was performed from May 2018 to June 2020 in the same center by 3 surgeons using the same surgical technique, 33 in the group without patch (control group - CG), and 31 in the Hemopatch group (HG), sealing with Hemopatch the duct-to-mucosa anastomosis. Results: Both groups were homogeneous. 41 were male (64.1%), mean age was 69 [59.9-74.5], and mean IMC was 25 [22.6-29]. Preoperative diagnosis was adenocarcinoma in 37 patients. All patients were operated by open approach, using a reconstruction in 2 loops and a duct-to-mucosa pancreatojejunostomy. In 39 patients the pancreas was soft. 18 patients had low Fistula Risk Score (FRS) and 42 medium FRS. POPF rate, including biochemical leakage was 40.6% (26 patients), and POPF grade B and C rate was 14.1% (9 patients). The rates of total POPF were 51.5% (17/33) in the CG and 27.3% (9/31) in the HG (p=0.033). The rates of POPF grade B and C were 24.2% (8/33) in the CG and 3.23% (1/31) in the HG (p=0.027). The risk of fistula was reduced by 76% (OR = 0.24, 95% CI=0.08-0.75) when using Hemopatch according to a logistic model adjusted for age, sex, and FRS. Other postoperative details are showed in Table 1. Although there was a trend in the HG to a lower rate of intra-abdominal abscess, delayed gastric emptying (DGE), major complications, readmission rates, and mortality, the difference was not statistically significant. Conclusion: Despite the limitations of the study (low number of patients, single-center study), Hemopatch may offer a decrease in clinically relevant POPF rates in PD. [Formula presented]