Effect of Thrombin-containing Collagen-based Hemostatic Matrix

NCT04357483 | Unknown Phase 4

• 1 other identifier: Collastat 2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Tumor

Keywords

Postoperative pancreatic fistula; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of POPF

  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).

  Three months

Secondary Outcomes (3)

• hospital length of stay

  Three months

• number of patient who received RBC transfusion

  One months

• Postoperative complication

  Three months

Study Arms (2)

Collastat

EXPERIMENTAL

Patients who were applied flowable thrombin containing collagen hemostat matrix after pancreatectomy

Drug: flowable thrombin containing collagen hemostat matrix

Collaseal

ACTIVE COMPARATOR

Patients who were applied thrombin coated L-dopa contained collagen patch after pancreatectomy

Drug: thrombin coated L-dopa contained collagen patch

Interventions

flowable thrombin containing collagen hemostat matrix DRUG

A 5 ml flowable hemostat matrix (CollaStat®) was applied to the stump or anastomosis site after pancreatectomy.

Also known as: CollaStat®

Collastat

thrombin coated L-dopa contained collagen patch DRUG

A 5x2.5cm sized thrombin coated L-dopa contained collagen patch (CollaSeal®) was applied to the stump or anastomosis site after pancreatectomy.

Also known as: CollaSeal®

Collaseal

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

RECRUITING

Related Publications (7)

• Schwartz M, Madariaga J, Hirose R, Shaver TR, Sher L, Chari R, Colonna JO 2nd, Heaton N, Mirza D, Adams R, Rees M, Lloyd D. Comparison of a new fibrin sealant with standard topical hemostatic agents. Arch Surg. 2004 Nov;139(11):1148-54. doi: 10.1001/archsurg.139.11.1148.

  PMID: 15545559 BACKGROUND

• Zegers M, de Bruijne MC, de Keizer B, Merten H, Groenewegen PP, van der Wal G, Wagner C. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies. Patient Saf Surg. 2011 May 20;5:13. doi: 10.1186/1754-9493-5-13.

  PMID: 21599915 BACKGROUND

• Chiara O, Cimbanassi S, Bellanova G, Chiarugi M, Mingoli A, Olivero G, Ribaldi S, Tugnoli G, Basilico S, Bindi F, Briani L, Renzi F, Chirletti P, Di Grezia G, Martino A, Marzaioli R, Noschese G, Portolani N, Ruscelli P, Zago M, Sgardello S, Stagnitti F, Miniello S. A systematic review on the use of topical hemostats in trauma and emergency surgery. BMC Surg. 2018 Aug 29;18(1):68. doi: 10.1186/s12893-018-0398-z.

  PMID: 30157821 BACKGROUND

• Suzuki Y, Kuroda Y, Morita A, Fujino Y, Tanioka Y, Kawamura T, Saitoh Y. Fibrin glue sealing for the prevention of pancreatic fistulas following distal pancreatectomy. Arch Surg. 1995 Sep;130(9):952-5. doi: 10.1001/archsurg.1995.01430090038015.

  PMID: 7661678 BACKGROUND

• Wilson C, Robinson S, French J, White S. Strategies to reduce pancreatic stump complications after open or laparoscopic distal pancreatectomy. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):109-17. doi: 10.1097/SLE.0b013e3182a2f07a.

  PMID: 24686344 BACKGROUND

• Rickenbacher A, Breitenstein S, Lesurtel M, Frilling A. Efficacy of TachoSil a fibrin-based haemostat in different fields of surgery--a systematic review. Expert Opin Biol Ther. 2009 Jul;9(7):897-907. doi: 10.1517/14712590903029172.

  PMID: 19527109 BACKGROUND

• Hiura Y, Takiguchi S, Yamamoto K, Kurokawa Y, Yamasaki M, Nakajima K, Miyata H, Fujiwara Y, Mori M, Doki Y. Use of fibrin glue sealant with polyglycolic acid sheets to prevent pancreatic fistula formation after laparoscopic-assisted gastrectomy. Surg Today. 2013 May;43(5):527-33. doi: 10.1007/s00595-012-0253-2. Epub 2012 Jul 14.

  PMID: 22797962 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Collagen

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Song Cheol Kim, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Central Study Contacts

Song Cheol Kim, MD, PhD

CONTACT

82-2-3010-3936; drksc@amc.seoul.kr

Yejong Park, MD, PhD

CONTACT

82-2-3010-3934; blackpig856@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Arm1 (intervention) : flowable thrombin containing collagen hemostat matrix Arm2 (Control) : thrombin coated L-dopa contained collagen patch

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: February 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)