<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03269955</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0791</org_study_id>
    <nct_id>NCT03269955</nct_id>
  </id_info>
  <brief_title>The Effect of Application of TachoSil® in Pancreatoduodenectomy</brief_title>
  <official_title>The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of&#xD;
      strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of&#xD;
      this study is to compare the incidence of pancreatic fistula that is most crucial for&#xD;
      surgical outcome and complications in pancreaticoduodenectomy with those of the control group&#xD;
      and the TachoSil® apply group.&#xD;
&#xD;
      Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic&#xD;
      pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase&#xD;
      4 clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of pancreatic fistula</measure>
    <time_frame>At 3 days after surgery</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically relevant pancreatic fistula</measure>
    <time_frame>At 5 days after surgery</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of complication except for pancreatic fistula</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal time of drainage</measure>
    <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</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>From date of surgery to 30 days after discharge</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-admission rate</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period of hospitalization after surgery</measure>
    <time_frame>From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year</time_frame>
    <description>The duration of the hospital stay is calculated based on the time when the actual patient is discharged.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Pancreatic Neoplasm</condition>
  <condition>Pancreatic Periampullary Cancer</condition>
  <condition>Pancreatic Bordeline Tumor</condition>
  <arm_group>
    <arm_group_label>application of TachoSil®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fibrinogen/thrombin-coated collagen patch</intervention_name>
    <description>Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it</description>
    <arm_group_label>application of TachoSil®</arm_group_label>
    <other_name>TachoSil®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECOG performance score of 0-2&#xD;
&#xD;
          -  Periampulary cancer or borderline tumor that is able to resection on preoperative&#xD;
             examination&#xD;
&#xD;
          -  Patients without distance metastasis&#xD;
&#xD;
          -  Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least&#xD;
             1,500/mm3, Platelet count at least 125,000/mm3&#xD;
&#xD;
          -  Liver function: AST/ALT less than 3 times upper limit of normal&#xD;
&#xD;
          -  Kidney function: Creatinine no greater than 1.5 times upper limit of normal&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with distant metastases are not eligible&#xD;
&#xD;
          -  Recurred periampulary cancer&#xD;
&#xD;
          -  Pregnant and breastfeeding women&#xD;
&#xD;
          -  Patients with active or uncontrolled infection&#xD;
&#xD;
          -  Patients with uncontrolled heart disease&#xD;
&#xD;
          -  Patients with moderate or severe comorbidities who are thought to have an impact on&#xD;
             quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart&#xD;
             failure, etc.)&#xD;
&#xD;
          -  Patients who underwent other major abdominal organs surgery except for scheduled&#xD;
             pancreatoduodenectomy (gastrectomy, colonic resection, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaehoon Lee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jaehoon Lee, Ph.D</last_name>
    <phone>+82-2-3010-1521</phone>
    <email>hbpsurgeon@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sookyung Lee</last_name>
    <phone>+82-2-3010-6921</phone>
    <email>goggle44@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpagu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaehoon Lee, Ph.D</last_name>
      <phone>+82-2-3010-1521</phone>
      <email>hbpsurgeon@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>16222456</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14707394</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18392243</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16269388</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14639354</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17909913</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18665071</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17457161</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21626319</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17703319</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21661439</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19381733</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23029624</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23095631</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21671113</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Jae Hoon Lee</investigator_full_name>
    <investigator_title>M.D, Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03269955
org study id: 2016-0791
nct id: NCT03269955
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Incidence of pancreatic fistula
time frame: At 3 days after surgery
description: 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.
measure: Incidence of clinically relevant pancreatic fistula
time frame: At 5 days after surgery
description: 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.
measure: Incidence of complication except for pancreatic fistula
time frame: Through study completion, an average of 1 year
description: 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.
measure: 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
description: 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.
measure: Death
time frame: From date of surgery to 30 days after discharge
description: 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.
measure: Re-admission rate
time frame: Through study completion, an average of 1 year
description: Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.
measure: 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
description: The duration of the hospital stay is calculated based on the time when the actual patient is discharged.
arm group label: application of TachoSil®
arm group type: Experimental
description: Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy
arm group label: control
arm group type: No Intervention
description: Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.
intervention type: Drug
intervention name: Fibrinogen/thrombin-coated collagen patch
description: Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
arm group label: application of TachoSil®
other name: TachoSil®
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jaehoon Lee, Ph.D
role: Principal Investigator
affiliation: Asan Medical Center
last name: Jaehoon Lee, Ph.D
phone: +82-2-3010-1521
email: hbpsurgeon@gmail.com
last name: Sookyung Lee
phone: +82-2-3010-6921
email: goggle44@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
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.
PMID: 21661439
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.
PMID: 19381733
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Jae Hoon Lee
investigator title: M.D, Ph.D
mesh term: Pancreatic Neoplasms
mesh term: Thrombin
sharing ipd: Undecided