The Effect of Application of TachoSil® in Pancreatoduodenectomy

NCT03269955 | Unknown Phase 4 DMC

• 1 other identifier: 2016-0791
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatic Neoplasm; Pancreatic Periampullary Cancer; Pancreatic Bordeline Tumor

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At 5 days after surgery

Secondary Outcomes (5)

• Incidence of complication except for pancreatic fistula

  Through study completion, an average of 1 year

• Removal time of drainage

  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

  From date of surgery to 30 days after discharge

• Re-admission rate

  Through study completion, an average of 1 year

• Period of hospitalization after surgery

  From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year

Study Arms (2)

application of TachoSil®

EXPERIMENTAL

Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy

Drug: Fibrinogen/thrombin-coated collagen patch

control

NO INTERVENTION

Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.

Interventions

Fibrinogen/thrombin-coated collagen patch DRUG

Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it

Also known as: TachoSil®

application of TachoSil®

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpagu, 05505, South Korea

RECRUITING

Related Publications (16)

• 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.

  PMID: 16222456 BACKGROUND

• Bassi 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.

  PMID: 14707394 BACKGROUND

• Benzoni 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.

  PMID: 18392243 BACKGROUND

• de 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.

  PMID: 16269388 BACKGROUND

• Bassi 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.

  PMID: 14639354 BACKGROUND

• Govindarajan 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.

  PMID: 17909913 BACKGROUND

• Satoi 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.

  PMID: 18665071 BACKGROUND

• Peng 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.

  PMID: 17457161 BACKGROUND

• Fernandez-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.

  PMID: 21626319 BACKGROUND

• Shrikhande 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.

  PMID: 17703319 BACKGROUND

• Mita 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.

  PMID: 21661439 BACKGROUND

• Chirletti 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.

  PMID: 19381733 BACKGROUND

• Simo 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.

  PMID: 23029624 BACKGROUND

• Montorsi 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.

  PMID: 23095631 BACKGROUND

• Pavlik 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.

  PMID: 21671113 BACKGROUND

• Kwon J, Shin SH, Lee S, Park G, Park Y, Lee SJ, Lee W, Song KB, Hwang DW, Kim SC, Lee JH. The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil(R)) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial. World J Surg. 2019 Dec;43(12):3128-3137. doi: 10.1007/s00268-019-05172-y.

  PMID: 31502003 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fibrinogen; TachoSil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Jaehoon Lee, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaehoon Lee, Ph.D

CONTACT

+82-2-3010-1521; hbpsurgeon@gmail.com

Sookyung Lee

CONTACT

+82-2-3010-6921; goggle44@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 1, 2017
• Study Start: February 27, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

KR (1)