Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000397

Trial Description

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Title

Selective Tissue elevation by pressure injection (STEP 2)

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Trial Acronym

STEP 2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To secure remove a colonadenoma international standard is a tissue elevation of the underlying tissue with the aim to minimize complications like bleeding or perforation. The standard technique is tissue elevation with a needle and a syringe. To further improve the technique we developed and tested successfully a water jet dissector (Helix HydroJet) for a selective deposition of liquid in the underlying tissue. To prove the superiority of our technique we employ this randomized study. All patients that fulfill the inclusion criteria and want to participate in the study will be randomly contributed to either one of the techniques and the data of the interventions will be collected and evaluated.

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Brief Summary in Scientific Language

We want to compare the efficacy of the water jet dissector (Helix HydroJet) for a selective deposition of liquid in the submucosa with the standard tissue elevation with a syringe to enable a endoscopic mucosa resection or endoscopic submucosal resection.

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Organizational Data

  •   DRKS00000397
  •   2010/04/21
  •   [---]*
  •   yes
  •   Approved
  •   2007-230N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1114-7016 
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Health Condition or Problem studied

  •   D12.0 -  Benign neoplasm: Caecum
  •   D12.2 -  Benign neoplasm: Ascending colon
  •   D12.3 -  Benign neoplasm: Transverse colon
  •   D12.4 -  Benign neoplasm: Descending colon
  •   D12.5 -  Benign neoplasm: Sigmoid colon
  •   D12.7 -  Benign neoplasm: Rectosigmoid junction
  •   D12.8 -  Benign neoplasm: Rectum
  •   Colon adenoma
  •   D37.4 -  Neoplasm of uncertain or unknown behaviour: Colon
  •   D37.5 -  Neoplasm of uncertain or unknown behaviour: Rectum
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Interventions/Observational Groups

  •   Selective submucosal tissue elevation preparing for EMR/ESD by pressure injection
  •   Convetional submucosal tissue elevation preparing for EMR/ESD with the syringe.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Intervention time

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Secondary Outcome

Completeness of the resection || Amount of part/lesion

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/11/16
  •   180
  •   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

Yamada I or II lesion > 12mm in the colon
patients to give an infored consent
normal blood coagulation: prothrombin time >65%, Partial Thromboplastin time <40 sec, platelets count > 50 000

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Exclusion Criteria

Recurrent lesions

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Addresses

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    • Zentrale Interdisziplinäre Endoskopie Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heidelberg
    • Mr.  Dr. med.  Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68135  Mannheim
    • Germany
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    • II. Medizinische Klinik Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heidelberg
    • Mr.  Dr. med.  Sebastian  Belle 
    • Therodor-Kutzer-Ufer 1-3
    • 68135  Mannheim
    • Germany
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    • Zentrale Interdisziplinäre Endoskopie Sekretariat Priv.-Doz. Dr. med. G. Kähler Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heidelberg
    • Ms.  Anja  Schmitt 
    • Theodor-Kutzer-Ufer 1-3
    • 68135  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentrale Interdisziplinäre Endoskopie Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heidelberg
    • Mr.  Dr. med.  Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68135  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/03/30
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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.