Effect of Thrombin-containing Collagen-based Hemostatic Matrix

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• Age: 20-80 years at the day of enrollment

• Performance: ECOG 0-2

• Patients who was scheduled for pancreatectomy due to benign or malignant tumor

• No distant metastasis

• Bone marrow function: WBC at least 3,000 / mm3, Platelet count at least 100,000 / mm3

• Liver function: AST / ALT less than 3 times upper limit of normal

• Kidney function: Creatinine no greater than 1.5 times upper limit of normal.

• Patients who consented to and signed the consent

Exclusion Criteria:

• Those with active or uncontrolled infections

• Those with severe psychiatric / neurological disorders

• Alcohol or other drug addicts

• Patients included in other clinical studies that may affect this study

• Patients who cannot follow the directions of the researcher

• Those with uncontrolled heart disease

• Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)

• Pelvic tumor, benign tumor, malignant tumor in other organs

• pregnant or planning on becoming pregnant during the follow-up period

• undergoing lymphatic or coagulation disease

• known sensitivity or allergy to bovine and/or porcine substance(s)