Trial document




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  DRKS00007915

Trial Description

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Title

Prospective open-label monocenter clinical trial to evaluate the safety and efficacy of a 2-octyl cyanoacrylate (2-OCA) bonding of the pancreatic remnant in the prevention of postoperative pancreatic fistula after distal pancreatic resection – the BOND-Trial

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Trial Acronym

BOND

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Based on the results of Barakat et al. 2012, topical 2-OCA application promises a substantial benefit in the prevention of POPF. Currently, there are only data available on the topical application to the pancreaticojejunal anastomosis after PD. Therefore, we intend to expand this promising technique to further pancreatic interventions. DP shows even higher rates of POPF compared to PD, thus, there may be a larger benefit for prevention of POPF in this indication.
Based on these facts, we conduct this trial in a proof-of-concept design to further develop the technique and to evaluate safety and preliminary efficacy in these indications.
The main objective of this study is to evaluate the safety of a 2-OCA application to the pancreatic remnant after distal pancreatectomy. Therefore all serious adverse events will be closely monitored. If the intervention proofs to be safe under these conditions, a multicenter RCT will be planned to evaluate the efficacy of this new and promising technique.
As primary efficacy parameter, the rate of POPF will be assessed.

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Organizational Data

  •   DRKS00007915
  •   2015/04/09
  •   [---]*
  •   yes
  •   Approved
  •   MZmo-577/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1169-1285 
  •   CIV-14-08-012601 
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Health Condition or Problem studied

  •   C25 -  Malignant neoplasm of pancreas
  •   K86 -  Other diseases of pancreas
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Interventions/Observational Groups

  •   Application of the sealant ETHICON(R) OMNEX(R) on the pancreatic remnant after distal pancreatic resection
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Frequency of (serious) adverse events and (serious) adverse device effects until 3 months postoperative

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Secondary Outcome

frequency of postoperative pancreatic fistula (according to the ISGPF definition)
frequency of other complications
Duration of surgery
length of postoperative hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/04/14
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patients scheduled for elective distal pancreatic resection (DP)
• ≥ 18 years of age
• Written informed consent

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Exclusion Criteria

• Haemoglobin< 10 g/dl
• Bilirubin > 3 times ULN
• AST or ALT > 4 ULN
• INR > 1.7
• Creatinine clearance < 30 ml/min (estimated by Cockcroft-Gault)
• Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
• Liver cirrhosis (of any Child-Pugh grade)
• ASA score > III
• Immunosuppressive therapy (cortison ≥ 40 mg/d or equivalent; azathioprin)
• Pregnancy or lactation
• Drug trial participation within 30 days before screening visit
• Understanding or language problems
• Inability to comply with study and/or follow-up procedures
• Allergy or known intolerability to 2-OCA, butyl-lactoyl cyanoacrylate or formaldehyde
• Any condition which could result in an undue risk for the patient in the opinion of the investigator

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Addresses

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    • Medizinische Fakultät der Ruprecht-Karls-Universität Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Klinik für Allgemein-Viszeral- und Transplantationschirurgie
    • Mr.  Felix  Hüttner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • am Universitätsklinikum Heidelberg
    • Studienzentrum der  Deutschen Gesellschaft für Chirurgie 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Heidelberger Stiftung Chirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.