Pancreatic TumorPhase 4TCMNCT04357483
Effect of Thrombin-containing Collagen-based Hemostatic Matrix
A Phase 4 study testing flowable thrombin containing collagen hemostat matrix and thrombin coated L-dopa contained collagen patch in people with Pancreatic Tumor, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- flowable thrombin containing collagen hemostat matrix and thrombin coated L-dopa contained collagen patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 30 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan medical center
Seoul, 05505
Song Cheol Kim, MD, PhD
Yejong Park, MD, PhD
About this study
Official title: Randomized Controlled Study to Evaluate the Effect of Thrombin-containing Collagen-based Hemostatic Matrix on Prevention of Pancreatic Fistula After Pancreatecomy
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.
Read more
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.
Read the detailed description
- Synopsis
- Title: Randomized controlled Study to evaluate the Effect of Thrombin-containing Collagen-based Hemostatic Matrix on Prevention of Pancreatic fistula after Pancreatectomy
- Study center: Single center from Korea
- Study type: Single center prospective randomized controlled study
- Planned study dates: February 2018 to September 2020
- Objectives ■ The aim of this study was to evaluate the safety and efficacy of flowable thrombin containing collagen hemostat matrix (T-C matrix) over the thrombin coated L-dopa contained collagen patch (T-CD patch) on clinical outcomes including PPH and POPF as a randomized controlled clinical trial.
- Background
- Hemostasis is the most basic and important procedure as a treatment for bleeding that inevitably follows most surgical procedures. Recently, with the development of pancreatic surgery and postoperative management, the mortality rate associated with surgery has decreased significantly, but the rate of complications due to massive bleeding or leakage of pancreatic fluid during surgery has not changed significantly. In hepatobiliary and pancreas (HBP) surgery, post-pancreatectomy hemorrhage (PPH) and postoperative pancreatic fistula (POPF) are both the main source of major morbidity and mortality.
- Collagen is a natural substrate for various kinds of animal cells, and contains a relatively large amount compared to other proteins in animal tissues, and can be easily extracted and purified from animal tissues. Collagen not only has low antigenicity, but also has excellent hemostatic effect and cell attachment ability, so it is often used as a major component of hemostatic agents and artificial tissue substitutes. In addition, collagen provides an environment in which fibroblasts can be produced and induces wound healing by inactivating elastase and matrix metalloproteases (MMPs).
- The investigators developed a novel flowable thrombin containing collagen hemostat matrix (T-C matrix) having flowable paste-like form. The T-C matrix consists of two connectable syringes, one of which contains collagen granules and thrombin, and the other contains calcium chloride (CaCl2) solution. Due to the flowable characteristic of the resultant matrix, T-C matrix can be easily applicable to irregular surface such as surgical site where anastomotic leakage is a concern. Currently, thrombin /coated L-3,4-dihydroxyphenylalanine (L-dopa DOPA) contained collagen patch (T-CD patch) are using on prevention of leakage and bleeding in pancreatic surgery. Although L-DOPA is known to contribute to adhesiveness which facilitates application of T-CD patch on wound sites, there are some controversial studies that L-DOPA have cytotoxicity and may induce inflammatory reaction with a high dose.
- Methodology
- The clinical study was designed to evaluate the effect of T-C matrix on the prevention of leakage in a pancreatectomy. The expected number of participants is 60.
- This clinical study is a randomized prospective comparative study of the outcome according to the hemostat materials as a non-inferiority test, and the research hypothesis is as follows. √ Null Hypothesis: There is no difference in the incidence of POPF between patients who were applied TC matrix (CollaStat®, Dalim Tissen. Co., Ltd., Korea) and T-CD patch (CollaSeal®, Dalim Tissen Co. Ltd., Korea) after pancreatectomy.
- In the case of evaluating the incidence of POPF after pancreatectomy, the results of previous studies of the 'leakage' ratio showed a leak prevention effect (θA) = 88% of the existing treatment method of CollaSeal® analog (Montorsi M et al. 2012). The new treatment effect (θT) is intended to demonstrate non-inferiority that does not exceed the non-inferiority limit (δ) compared to the existing treatment effect (θA). The non-inferiority limit (δ) was calculated by more than 75% of the existing treatment effect. The non-inferiority limit was calculated to be 0.22 based on the case where more than 75% of the 88% of the existing treatment method is confirmed, that is, the treatment success rate is more than 66%. It was decided that CollaStat® was non-inferior to CollaSeal® when the lower limit of the 95% CI for the difference between the two groups was greater than -0.22. If the allocation ratio between the two groups is 1: 1 and the first-class error α = 5% and the second-class error β = 20%, considering the dropout rate of 10%, 30 study groups and control groups each need 30 subjects.
- The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.
- Conditions
- Pancreatic Tumor
- Being tested
- flowable thrombin containing collagen hemostat matrix, thrombin coated L-dopa contained collagen patch
- Keywords
- Postoperative pancreatic fistula, Pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flowable thrombin containing collagen hemostat matrixDrug
Also called CollaStat®
A 5 ml flowable hemostat matrix (CollaStat®) was applied to the stump or anastomosis site after pancreatectomy.
thrombin coated L-dopa contained collagen patchDrug
Also called CollaSeal®
A 5x2.5cm sized thrombin coated L-dopa contained collagen patch (CollaSeal®) was applied to the stump or anastomosis site after pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Collastat | Experimental | Patients who were applied flowable thrombin containing collagen hemostat matrix after pancreatectomy Receives: Drug: flowable thrombin containing collagen hemostat matrix |
| Collaseal | Active comparator | Patients who were applied thrombin coated L-dopa contained collagen patch after pancreatectomy Receives: Drug: thrombin coated L-dopa contained collagen patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three months
Secondary outcomes (3)
hospital length of stay
The length of hospital stay after surgery is observed.
Measured: Three months
number of patient who received RBC transfusion
The amount of blood transfusion performed during surgery should be described.
Measured: One months
Postoperative complication
According to the Clavien-Dindo classification, the grade of complication including readmission should be described.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Feb 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pancreatic TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm1 (intervention) : flowable thrombin containing collagen hemostat matrix Arm2 (Control) : thrombin coated L-dopa contained collagen patch
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song Cheol Kim, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357483
- Sponsor's protocol ID
- Collastat 2020
- Acronym
- TCM
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15545559Zegers 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.
PubMed 21599915Chiara 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.
PubMed 30157821Suzuki 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.
PubMed 7661678Wilson 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.
PubMed 24686344Rickenbacher 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.
PubMed 19527109Hiura 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.
PubMed 22797962
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Effect of Thrombin-containing Collagen-based Hemostatic Matrix on Prevention of Pancreatic Fistula After Pancreatecomy
- ClinicalTrials.gov ID
- NCT04357483
- Acronym / sponsor ID
- TCM / Collastat 2020
- Conditions
- Pancreatic Tumor
- Keywords
- Postoperative pancreatic fistula, Pancreatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Synopsis
- Title: Randomized controlled Study to evaluate the Effect of Thrombin-containing Collagen-based Hemostatic Matrix on Prevention of Pancreatic fistula after Pancreatectomy
- Study center: Single center from Korea
- Study type: Single center prospective randomized controlled study
- Planned study dates: February 2018 to September 2020
- Objectives ■ The aim of this study was to evaluate the safety and efficacy of flowable thrombin containing collagen hemostat matrix (T-C matrix) over the thrombin coated L-dopa contained collagen patch (T-CD patch) on clinical outcomes including PPH and POPF as a randomized controlled clinical trial.
- Background
- Hemostasis is the most basic and important procedure as a treatment for bleeding that inevitably follows most surgical procedures. Recently, with the development of pancreatic surgery and postoperative management, the mortality rate associated with surgery has decreased significantly, but the rate of complications due to massive bleeding or leakage of pancreatic fluid during surgery has not changed significantly. In hepatobiliary and pancreas (HBP) surgery, post-pancreatectomy hemorrhage (PPH) and postoperative pancreatic fistula (POPF) are both the main source of major morbidity and mortality.
- Collagen is a natural substrate for various kinds of animal cells, and contains a relatively large amount compared to other proteins in animal tissues, and can be easily extracted and purified from animal tissues. Collagen not only has low antigenicity, but also has excellent hemostatic effect and cell attachment ability, so it is often used as a major component of hemostatic agents and artificial tissue substitutes. In addition, collagen provides an environment in which fibroblasts can be produced and induces wound healing by inactivating elastase and matrix metalloproteases (MMPs).
- The investigators developed a novel flowable thrombin containing collagen hemostat matrix (T-C matrix) having flowable paste-like form. The T-C matrix consists of two connectable syringes, one of which contains collagen granules and thrombin, and the other contains calcium chloride (CaCl2) solution. Due to the flowable characteristic of the resultant matrix, T-C matrix can be easily applicable to irregular surface such as surgical site where anastomotic leakage is a concern. Currently, thrombin /coated L-3,4-dihydroxyphenylalanine (L-dopa DOPA) contained collagen patch (T-CD patch) are using on prevention of leakage and bleeding in pancreatic surgery. Although L-DOPA is known to contribute to adhesiveness which facilitates application of T-CD patch on wound sites, there are some controversial studies that L-DOPA have cytotoxicity and may induce inflammatory reaction with a high dose.
- Methodology
- The clinical study was designed to evaluate the effect of T-C matrix on the prevention of leakage in a pancreatectomy. The expected number of participants is 60.
- This clinical study is a randomized prospective comparative study of the outcome according to the hemostat materials as a non-inferiority test, and the research hypothesis is as follows. √ Null Hypothesis: There is no difference in the incidence of POPF between patients who were applied TC matrix (CollaStat®, Dalim Tissen. Co., Ltd., Korea) and T-CD patch (CollaSeal®, Dalim Tissen Co. Ltd., Korea) after pancreatectomy.
- In the case of evaluating the incidence of POPF after pancreatectomy, the results of previous studies of the 'leakage' ratio showed a leak prevention effect (θA) = 88% of the existing treatment method of CollaSeal® analog (Montorsi M et al. 2012). The new treatment effect (θT) is intended to demonstrate non-inferiority that does not exceed the non-inferiority limit (δ) compared to the existing treatment effect (θA). The non-inferiority limit (δ) was calculated by more than 75% of the existing treatment effect. The non-inferiority limit was calculated to be 0.22 based on the case where more than 75% of the 88% of the existing treatment method is confirmed, that is, the treatment success rate is more than 66%. It was decided that CollaStat® was non-inferior to CollaSeal® when the lower limit of the 95% CI for the difference between the two groups was greater than -0.22. If the allocation ratio between the two groups is 1: 1 and the first-class error α = 5% and the second-class error β = 20%, considering the dropout rate of 10%, 30 study groups and control groups each need 30 subjects.
- The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Arm1 (intervention) : flowable thrombin containing collagen hemostat matrix Arm2 (Control) : thrombin coated L-dopa contained collagen patch
| Arm | Type | Receives |
|---|---|---|
| Collastat | Experimental | Drug: flowable thrombin containing collagen hemostat matrixPatients who were applied flowable thrombin containing collagen hemostat matrix after pancreatectomy |
| Collaseal | Active comparator | Drug: thrombin coated L-dopa contained collagen patchPatients who were applied thrombin coated L-dopa contained collagen patch after pancreatectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flowable thrombin containing collagen hemostat matrixAlso: CollaStat®A 5 ml flowable hemostat matrix (CollaStat®) was applied to the stump or anastomosis site after pancreatectomy. | Drug | Collastat |
| thrombin coated L-dopa contained collagen patchAlso: CollaSeal®A 5x2.5cm sized thrombin coated L-dopa contained collagen patch (CollaSeal®) was applied to the stump or anastomosis site after pancreatectomy. | Drug | Collaseal |
Primary outcome
Incidence of POPF
Time frame: Three months
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).
3 secondary outcomes
hospital length of stay
Time frame: Three months
number of patient who received RBC transfusion
Time frame: One months
Postoperative complication
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 15545559Schwartz 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.
- Background: PubMed 21599915Zegers 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.
- Background: PubMed 30157821Chiara 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.
- Background: PubMed 7661678Suzuki 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.
- Background: PubMed 24686344Wilson 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.
- Background: PubMed 19527109Rickenbacher 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.
- Background: PubMed 22797962Hiura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Cheol Kim, MD, PhD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing flowable thrombin containing collagen hemostat matrix and thrombin coated L-dopa contained collagen patch in people with Pancreatic Tumor, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song Cheol Kim, MD, PhD (82-2-3010-3936, drksc@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POPF (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357483, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.