Effect of Thrombin-containing Collagen-based Hemostatic Matrix
Status:
Recruiting
Trial end date:
2020-09-30
Target enrollment:
Participant gender:
Summary
Under the hypothesis that collagen-based hemostatic agents improve the suppression of leakage
of hemostatic pancreatic fluid at the surgical site during surgery, thrombin-containing
collagen-based hemostatic agents are applied in surgery in patients with pancreatectomy. The
investigators intend to evaluate the effectiveness of collagen-based hemostatic agents
containing thrombin through clinical evaluation of hemostatic effect and anti-leakage effect
of pancreatic fluid.
This clinical study is a study for comparative evaluation of hemostasis and anti-leakage
effect of bile or pancreatic fluid when applied after pancreatic resection of a
collagen-based hemostatic agent containing thrombin. It is prospective, single center,
randomized, and non-inferiority test. Participants are patients who are diagnosed with
pancreatic disease and other diseases, and plan to undergo pancreatectomy. Through the
randomization, in the case of the intervention group, after the pancreatectomy, the Collastat
(CollaStat®, Dalim Tissen. Co., Ltd., Korea) is applied to the cut surface, and in the case
of the control group, Collaseal (CollaSeal®, Dalim Tissen. Co., Ltd., Korea) is applied. In
this study, 30 participants were required for each intervention group and control group.
After surgery, the participants is hospitalized for 7 days and undergoes follow-up
observation. Pancreatic leakage is measured through the drainage tube before discharge and
evaluated as biochemical leakage (BL), B, or C according to the definition of International
Study Group for Pancreatic Fistula (ISGPS).
The primary endpoint of this study was the prevention rate of leakage. The postoperative
pancreatic fistula (POPF) was defined according to the definition of ISGPS. Secondary end
point was assessed as the difference between groups of total number of collagen hemostatic
agents used, hospital length of stay and number of patient who received RBC transfusion.
Safety was assessed based on the incidence of adverse events occurred.