Clinical trial NCT03269955: The Effect of Application of TachoSil® in Pancreatoduodenectomy
Official title: The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatic Neoplasm
Pancreatic Periampullary Cancer
Pancreatic Bordeline Tumor
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 126
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Incidence of pancreatic fistula
timeFrame: At 3 days after surgery
measure: Incidence of clinically relevant pancreatic fistula
timeFrame: At 5 days after surgery
Secondary outcomes:
measure: Incidence of complication except for pancreatic fistula
timeFrame: Through study completion, an average of 1 year
measure: Removal time of drainage
timeFrame: 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
measure: Death
timeFrame: From date of surgery to 30 days after discharge
measure: Re-admission rate
timeFrame: Through study completion, an average of 1 year
measure: Period of hospitalization after surgery
timeFrame: From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpagu
Study officials:
affiliation: Asan Medical Center
name: Jaehoon Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.