Detailed Abstract
[BP Poster Presentation 2]
[P087] The effect of application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil? in pancreaticojejunostomy for prevention of pancreatic fistula after pancreatoduodenectomy : a randomized clinical trial
Jaewoo KWON1, Jae Hoon LEE* 1, Sang Hyun SHIN1, 2, Daegwang YOO1, Sarang HONG1, Jong Woo LEE1, Woo Young YOUN1, Kyungyeon HWANG1, Guisuk PARK1, Yejong PARK1, Seung Jae LEE1, Woohyung LEE1, Ki Byung SONG1, Dae Wook HWANG1, Song Cheol KIM1
1Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan college of Medicine and Asan Medical Center, Korea
2Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Korea
Introduction : For reducing of postoperative pancreatic fistula (POPF) after pancreatico-enteric anastomosis, fibrin sealants and topical glue were studied previously, but there has been no definite conclusion to reduce POPF innovatively. The purpose of this study was to evaluate effectiveness of applying fibrin sealant patch to pancreatico-enteric anastomosis to reduce postoperative complications including POPF.
Methods : It was designed as a single center, prospective, randomized, parallel-group, phase IV, single blind (participant) with three pancreas-biliary surgeons. The primary outcome was POPF. Secondary outcome included complication, removal of drainage, hospital stay, readmission rate and cost. Risk factors for POPF were identified by logistic regression analysis.
Results : A total 124 patients were enrolled. Biochemical leakage or POPF occurred 16 patients (25.8%) in intervention group, 23 patients (37.1%) in control group. Occurrence rate was different, but there was no statistically significant difference. Clinical relevant POPF occurred in 4 patients (6.5%) in intervention group, same as control group (p=1.000). Hospital stay (11.6 days vs 12.1 days, p=0.585) and drain removal days (5.7 days vs 5.3 days, p=0.281) were not different between two groups. Complication rate was not different between two group (p=0.506). Readmission rate (12.9 % vs 11.3 %, p=1.000) and cost (13549 $ vs 15038 $, p=0.103) were not different between two group. A multivariable logistic regression model identified age, pancreas texture, fibrin sealant patch as independent risk factors for biochemical leakage or POPF.
Conclusions : Fibrin sealant patch after pancreaticojejunostomy did not reduce the incidence of POPF and postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).
Methods : It was designed as a single center, prospective, randomized, parallel-group, phase IV, single blind (participant) with three pancreas-biliary surgeons. The primary outcome was POPF. Secondary outcome included complication, removal of drainage, hospital stay, readmission rate and cost. Risk factors for POPF were identified by logistic regression analysis.
Results : A total 124 patients were enrolled. Biochemical leakage or POPF occurred 16 patients (25.8%) in intervention group, 23 patients (37.1%) in control group. Occurrence rate was different, but there was no statistically significant difference. Clinical relevant POPF occurred in 4 patients (6.5%) in intervention group, same as control group (p=1.000). Hospital stay (11.6 days vs 12.1 days, p=0.585) and drain removal days (5.7 days vs 5.3 days, p=0.281) were not different between two groups. Complication rate was not different between two group (p=0.506). Readmission rate (12.9 % vs 11.3 %, p=1.000) and cost (13549 $ vs 15038 $, p=0.103) were not different between two group. A multivariable logistic regression model identified age, pancreas texture, fibrin sealant patch as independent risk factors for biochemical leakage or POPF.
Conclusions : Fibrin sealant patch after pancreaticojejunostomy did not reduce the incidence of POPF and postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).
SESSION
BP Poster Presentation 2
Room E 4/6/2019 3:00 PM - 3:50 PM