NCT04357483: TCM

Effect of Thrombin-containing Collagen-based Hemostatic Matrix

Status unknown Phase 4 Last updated 28 April 2020

What this trial tests

Phase 4 trial testing flowable thrombin containing collagen hemostat matrix in Pancreatic Tumor in 60 participants. Status unknown.

Timeline

1 February 2018

Primary endpoint
31 July 2020

30 September 2020

Quick facts

Lead sponsor	Asan Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	60
Start date	1 February 2018
Primary completion	31 July 2020
Estimated completion	30 September 2020
Sites	1 location across South Korea

Drugs / interventions tested

• flowable thrombin containing collagen hemostat matrix — full drug profile →
• thrombin coated L-dopa contained collagen patch — full drug profile →

Conditions studied

• Pancreatic Tumor — all drugs for Pancreatic Tumor →

Sponsor

Asan Medical Center

Who can join

Adults 20 to 80, any sex, with Pancreatic Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial.
   Park Y, Ko JH, Kang DR, Lee JH, et al · · 2020 · cited 3× · PMID 32987876 · DOI 10.3390/jcm9103085