Trial document




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  DRKS00000169

Trial Description

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Title

Prospective singlecenter trial comparing the efficiency of Spiral Enteroscopy (SE) and Double Balloon Enteroscopy (DBE) in patients with small bowel disorders

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Trial Acronym

[---]*

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URL of the Trial

http://--

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Brief Summary in Lay Language

Patients have been diagnosed with small bowel disease. Using a recent endoscopy technique, it is possible to examine the entire small bowel and therefore confirm supposed diseases, take biopsies, or undertake therapeutical procedures. Double Balloon Endoscopy is a well-respected device for this endoscopy technique. Now, it is to be investigated whether Double Balloon Endoscopy or the new developed Spiral Endoscopy is the more efficient technique. From the positive results obtained so far it can be deduced that examination time is significantly shortend by Spiral Endoscopy. It is to be investigated whether a compareable penetration depth is achieved. Our goal is to investigate whether complete enteroscopies are achieved more often using DBE or SE.

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Brief Summary in Scientific Language

Since the push-and-pull enteroscopy invention, the Double Balloon technique is well-respected and -used particularly throughout Germany. Ideally, an entire enteroscopy can be achieved, even though in most cases an oral and anal double-balloon endoscopy (DBE) has to be combined. Alternatively, the newly developed Spiral Endoscopy (SE) technique can be used. Apparently, the time necessary for investigating patients is shorter using spiral endoscopy. But, anal penetration depth is limited. Therefore we assume that using DBE more complete enteroscopies are achieved than by SE. This will be further investigated in our prospective, unicentric and randomized study. Our goal is to investigate, whether complete enteroscopies are achieved 12 times as frequent using DBE or SE. Secondary goals are to determine the time required for investigation as well as the time needed to reach the point with the maximum penetration depth and the diagnostic efficiency.

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Organizational Data

  •   DRKS00000169
  •   2009/09/17
  •   [---]*
  •   yes
  •   Approved
  •   FF51/2009, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   suspected or known small bowel disease
  •   C17 -  Malignant neoplasm of small intestine
  •   K50.0 -  Crohn's disease of small intestine
  •   K51.1 -  Ulcerative (chronic) ileocolitis
  •   K55 -  Vascular disorders of intestine
  •   K92.2 -  Gastrointestinal haemorrhage, unspecified
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Interventions/Observational Groups

  •   double balloon enteroscopy (oral +/- anal route)
  •   spiral enteroscopy (oral +/- anal route)
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Characteristics

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

Our goal is to investigate whether complete enteroscopies are achieved 12 times as frequent using DBE or SE.

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Secondary Outcome

Secondary goals are to determine the time required for investigation as well as the diagnostic efficiency.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/09/04
  •   26
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- Patients older than 18 years
- Suspected or diagnosed small bowel diseases
- Diagnostic enteroscopy
- APC of maximal 10 angiodysplasias

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Exclusion Criteria

- Missing consent
- Pregnancy
- Coagulation disorders (Quick <60%, PTT > 50 s, WBC< 100.000/ml)
- Patients post colon / small bowle resections
- APC in more than 10 angiodysplasias, other therapeutic interventions (polypectomy, dilations of stenoses, foreign body removal, stent implantation) during enteroscopy

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Addresses

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    • HSK Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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    • HSK Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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    • HSK Wiesbaden, Innere Medizin 2
    • Ms.  Dr. med.  Insa  Aschmoneit 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • HSK Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/03/15
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Trial Publications, Results and other Documents

  •   Gastrointest Endosc. 2012 Oct 5. pii: S0016-5107(12)02640-5. doi: 10.1016/j.gie.2012.08.020. [Epub ahead of print] Prospective, randomized, single-center trial comparing double-balloon enteroscopy and spiral enteroscopy in patients with suspected small-bowel disorders. Messer I, May A, Manner H, Ell C.
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* This entry means the parameter is not applicable or has not been set.