Pancreatic NeoplasmPhase 4NCT03269955
The Effect of Application of TachoSil® in Pancreatoduodenectomy
A Phase 4 study testing Fibrinogen/thrombin-coated collagen patch in people with Pancreatic Neoplasm and Pancreatic Periampullary Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreatic Neoplasm, Pancreatic Periampullary Cancer, Pancreatic Bordeline Tumor
- What is being tested?
- Fibrinogen/thrombin-coated collagen patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2017to May 2018
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance score of 0-2
- Periampulary cancer or borderline tumor that is able to resection on preoperative examination
- Patients without distance metastasis
- Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/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
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with distant metastases are not eligible
- Recurred periampulary cancer
- Pregnant and breastfeeding women
- Patients with active or uncontrolled infection
- Patients with uncontrolled heart disease
- Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.)
- Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpagu, 05505
Jaehoon Lee, Ph.D, +82-2-3010-1521, hbpsurgeon@gmail.com
About this study
Official title: The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group.
Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.
- Being tested
- Fibrinogen/thrombin-coated collagen patch
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen/thrombin-coated collagen patchDrug
Also called TachoSil®
Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
| Study group | Role | What they receive |
|---|---|---|
| application of TachoSil® | Experimental | Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy Receives: Drug: Fibrinogen/thrombin-coated collagen patch |
| control | No intervention | Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula
The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood.
Measured: At 3 days after surgery
Incidence of clinically relevant pancreatic fistula
The grade uses ISGPF grading, while the grades B and C are clinically relevant pancreatic fistula. All patients underwent abdominal CT at 5 days postoperatively for grade evaluation.
Measured: At 5 days after surgery
Secondary outcomes (5)
Incidence of complication except for pancreatic fistula
Complications other than pancreatitis include all complications after pancreatoduodenectomy. Delayed gastric emptying and postoperative bleeding complied with the criteria of the International Study Group, and the severity of complications is classified through the Clavien-Dindo classification.
Measured: Through study completion, an average of 1 year
Removal time of drainage
The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon.
Measured: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year
Death
The results are for patients who died during hospitalization. If a patient is discharged within 30 days of discharge, the death rate is the same as during death.
Measured: From date of surgery to 30 days after discharge
Re-admission rate
Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.
Measured: Through study completion, an average of 1 year
Period of hospitalization after surgery
The duration of the hospital stay is calculated based on the time when the actual patient is discharged.
Measured: From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start27 Feb 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hoon Lee, Asan Medical Center
- Investigators
- Jaehoon Lee, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269955
- Sponsor's protocol ID
- 2016-0791
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suzuki Y, Fujino Y, Ajiki T, Ueda T, Sakai T, Tanioka Y, Kuroda Y. No mortality among 100 consecutive pancreaticoduodenectomies in a middle-volume center. World J Surg. 2005 Nov;29(11):1409-14. doi: 10.1007/s00268-005-0152-4.
PubMed 16222456Bassi C, Butturini G, Molinari E, Mascetta G, Salvia R, Falconi M, Gumbs A, Pederzoli P. Pancreatic fistula rate after pancreatic resection. The importance of definitions. Dig Surg. 2004;21(1):54-9. doi: 10.1159/000075943. Epub 2003 Dec 30.
PubMed 14707394Benzoni E, Zompicchiatti A, Saccomano E, Lorenzin D, Baccarani U, Adani G, Noce L, Uzzau A, Cedolini C, Bresadola F, Intini S. Postoperative complications linked to pancreaticoduodenectomy. An analysis of pancreatic stump management. J Gastrointestin Liver Dis. 2008 Mar;17(1):43-7. doi: 10.1007/s11749-008-0106-x.
PubMed 18392243de Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Incidence and management of biliary leakage after hepaticojejunostomy. J Gastrointest Surg. 2005 Nov;9(8):1163-71; discussion 1171-3. doi: 10.1016/j.gassur.2005.08.010.
PubMed 16269388Bassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, Salvia R, Pederzoli P. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003 Nov;134(5):766-71. doi: 10.1016/s0039-6060(03)00345-3.
PubMed 14639354Govindarajan A, Tan JC, Baxter NN, Coburn NG, Law CH. Variations in surgical treatment and outcomes of patients with pancreatic cancer: a population-based study. Ann Surg Oncol. 2008 Jan;15(1):175-85. doi: 10.1245/s10434-007-9601-7. Epub 2007 Oct 2.
PubMed 17909913Satoi S, Toyokawa H, Yanagimoto H, Yamamoto T, Yamao J, Kim S, Matsui Y, Takai S, Mergental H, Kamiyama Y; Department of Surgery, Kansai Medical University, Osaka, Japan. A new guideline to reduce postoperative morbidity after pancreaticoduodenectomy. Pancreas. 2008 Aug;37(2):128-33. doi: 10.1097/MPA.0b013e318162cb53.
PubMed 18665071Peng SY, Wang JW, Lau WY, Cai XJ, Mou YP, Liu YB, Li JT. Conventional versus binding pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007 May;245(5):692-8. doi: 10.1097/01.sla.0000255588.50964.5d.
PubMed 17457161Fernandez-Cruz L, Belli A, Acosta M, Chavarria EJ, Adelsdorfer W, Lopez-Boado MA, Ferrer J. Which is the best technique for pancreaticoenteric reconstruction after pancreaticoduodenectomy? A critical analysis. Surg Today. 2011 Jun;41(6):761-6. doi: 10.1007/s00595-011-4515-1. Epub 2011 May 28.
PubMed 21626319Shrikhande SV, Barreto G, Shukla PJ. Pancreatic fistula after pancreaticoduodenectomy: the impact of a standardized technique of pancreaticojejunostomy. Langenbecks Arch Surg. 2008 Jan;393(1):87-91. doi: 10.1007/s00423-007-0221-2. Epub 2007 Aug 17.
PubMed 17703319Mita K, Ito H, Fukumoto M, Murabayashi R, Koizumi K, Hayashi T, Kikuchi H, Kagaya T. A fibrin adhesive sealing method for the prevention of pancreatic fistula following distal pancreatectomy. Hepatogastroenterology. 2011 Mar-Apr;58(106):604-8.
PubMed 21661439Chirletti P, Caronna R, Fanello G, Schiratti M, Stagnitti F, Peparini N, Benedetti M, Martino G. Pancreaticojejunostomy with application of fibrinogen/thrombin-coated collagen patch (TachoSil) in Roux-en-Y reconstruction after pancreaticoduodenectomy. J Gastrointest Surg. 2009 Jul;13(7):1396-8; author reply 1399-400. doi: 10.1007/s11605-009-0894-7. Epub 2009 Apr 18. No abstract available.
PubMed 19381733Simo KA, Hanna EM, Imagawa DK, Iannitti DA. Hemostatic Agents in Hepatobiliary and Pancreas Surgery: A Review of the Literature and Critical Evaluation of a Novel Carrier-Bound Fibrin Sealant (TachoSil). ISRN Surg. 2012;2012:729086. doi: 10.5402/2012/729086. Epub 2012 Sep 13.
PubMed 23029624Montorsi M, Zerbi A, Bassi C, Capussotti L, Coppola R, Sacchi M; Italian Tachosil Study Group. Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial. Ann Surg. 2012 Nov;256(5):853-9; discussion 859-60. doi: 10.1097/SLA.0b013e318272dec0.
PubMed 23095631Pavlik Marangos I, Rosok BI, Kazaryan AM, Rosseland AR, Edwin B. Effect of TachoSil patch in prevention of postoperative pancreatic fistula. J Gastrointest Surg. 2011 Sep;15(9):1625-9. doi: 10.1007/s11605-011-1584-9. Epub 2011 Jun 14.
PubMed 21671113
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT03269955
- Acronym / sponsor ID
- 2016-0791
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 1 Sep 2017 (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.
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group.
Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application of TachoSil® | Experimental | Drug: Fibrinogen/thrombin-coated collagen patchFibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy |
| control | No intervention | –Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG performance score of 0-2
- Periampulary cancer or borderline tumor that is able to resection on preoperative examination
- Patients without distance metastasis
- Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- Liver function: AST/ALT less than 3 times upper limit of normal
Key exclusion criteria (7 listed)
- Patients with distant metastases are not eligible
- Recurred periampulary cancer
- Pregnant and breastfeeding women
- Patients with active or uncontrolled infection
- Patients with uncontrolled heart disease
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 |
|---|---|---|
| Fibrinogen/thrombin-coated collagen patchAlso: TachoSil®Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it | Drug | application of TachoSil® |
Primary outcome
Incidence of pancreatic fistula
Time frame: At 3 days after surgery
The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood.
Incidence of clinically relevant pancreatic fistula
Time frame: At 5 days after surgery
The grade uses ISGPF grading, while the grades B and C are clinically relevant pancreatic fistula. All patients underwent abdominal CT at 5 days postoperatively for grade evaluation.
5 secondary outcomes
Incidence of complication except for pancreatic fistula
Time frame: Through study completion, an average of 1 year
Removal time of drainage
Time frame: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year
Death
Time frame: From date of surgery to 30 days after discharge
Re-admission rate
Time frame: Through study completion, an average of 1 year
Period of hospitalization after surgery
Time frame: From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 16222456Suzuki Y, Fujino Y, Ajiki T, Ueda T, Sakai T, Tanioka Y, Kuroda Y. No mortality among 100 consecutive pancreaticoduodenectomies in a middle-volume center. World J Surg. 2005 Nov;29(11):1409-14. doi: 10.1007/s00268-005-0152-4.
- Background: PubMed 14707394Bassi C, Butturini G, Molinari E, Mascetta G, Salvia R, Falconi M, Gumbs A, Pederzoli P. Pancreatic fistula rate after pancreatic resection. The importance of definitions. Dig Surg. 2004;21(1):54-9. doi: 10.1159/000075943. Epub 2003 Dec 30.
- Background: PubMed 18392243Benzoni E, Zompicchiatti A, Saccomano E, Lorenzin D, Baccarani U, Adani G, Noce L, Uzzau A, Cedolini C, Bresadola F, Intini S. Postoperative complications linked to pancreaticoduodenectomy. An analysis of pancreatic stump management. J Gastrointestin Liver Dis. 2008 Mar;17(1):43-7. doi: 10.1007/s11749-008-0106-x.
- Background: PubMed 16269388de Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Incidence and management of biliary leakage after hepaticojejunostomy. J Gastrointest Surg. 2005 Nov;9(8):1163-71; discussion 1171-3. doi: 10.1016/j.gassur.2005.08.010.
- Background: PubMed 14639354Bassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, Salvia R, Pederzoli P. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003 Nov;134(5):766-71. doi: 10.1016/s0039-6060(03)00345-3.
- Background: PubMed 17909913Govindarajan A, Tan JC, Baxter NN, Coburn NG, Law CH. Variations in surgical treatment and outcomes of patients with pancreatic cancer: a population-based study. Ann Surg Oncol. 2008 Jan;15(1):175-85. doi: 10.1245/s10434-007-9601-7. Epub 2007 Oct 2.
- Background: PubMed 18665071Satoi S, Toyokawa H, Yanagimoto H, Yamamoto T, Yamao J, Kim S, Matsui Y, Takai S, Mergental H, Kamiyama Y; Department of Surgery, Kansai Medical University, Osaka, Japan. A new guideline to reduce postoperative morbidity after pancreaticoduodenectomy. Pancreas. 2008 Aug;37(2):128-33. doi: 10.1097/MPA.0b013e318162cb53.
- Background: PubMed 17457161Peng SY, Wang JW, Lau WY, Cai XJ, Mou YP, Liu YB, Li JT. Conventional versus binding pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007 May;245(5):692-8. doi: 10.1097/01.sla.0000255588.50964.5d.
- Background: PubMed 21626319Fernandez-Cruz L, Belli A, Acosta M, Chavarria EJ, Adelsdorfer W, Lopez-Boado MA, Ferrer J. Which is the best technique for pancreaticoenteric reconstruction after pancreaticoduodenectomy? A critical analysis. Surg Today. 2011 Jun;41(6):761-6. doi: 10.1007/s00595-011-4515-1. Epub 2011 May 28.
- Background: PubMed 17703319Shrikhande SV, Barreto G, Shukla PJ. Pancreatic fistula after pancreaticoduodenectomy: the impact of a standardized technique of pancreaticojejunostomy. Langenbecks Arch Surg. 2008 Jan;393(1):87-91. doi: 10.1007/s00423-007-0221-2. Epub 2007 Aug 17.
- Background: PubMed 21661439Mita K, Ito H, Fukumoto M, Murabayashi R, Koizumi K, Hayashi T, Kikuchi H, Kagaya T. A fibrin adhesive sealing method for the prevention of pancreatic fistula following distal pancreatectomy. Hepatogastroenterology. 2011 Mar-Apr;58(106):604-8.
- Background: PubMed 19381733Chirletti P, Caronna R, Fanello G, Schiratti M, Stagnitti F, Peparini N, Benedetti M, Martino G. Pancreaticojejunostomy with application of fibrinogen/thrombin-coated collagen patch (TachoSil) in Roux-en-Y reconstruction after pancreaticoduodenectomy. J Gastrointest Surg. 2009 Jul;13(7):1396-8; author reply 1399-400. doi: 10.1007/s11605-009-0894-7. Epub 2009 Apr 18. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Jaehoon Lee, Ph.D principal investigator
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 Fibrinogen/thrombin-coated collagen patch in people with Pancreatic Neoplasm and Pancreatic Periampullary Cancer, 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 7 inclusion and 7 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 1 Sep 2017. 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 Jaehoon Lee, Ph.D (+82-2-3010-1521, hbpsurgeon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pancreatic fistula (time frame: At 3 days after surgery). The study lists 2 primary outcomes in all. 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 NCT03269955, which also lists 16 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 1 Sep 2017.