Trial document





This trial has been registered retrospectively.
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  DRKS00000091

Trial Description

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Title

Prospective multicenter trial comparing Double Balloon enteroscopy (DBE) and Single balloon enteroscopy (SBE) in patients with small bowel disorders

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Until only a few years ago, it was not possible to access most of the small bowel using endoscopic techniques that avoided the need for surgery. Video capsule endoscopy and balloon enteroscopy thus represent decisive breakthroughs in this field. Balloon enteroscopy using the double or single ballon technique is a more invasive procedure in comparison with capsule endoscopy. The single balloon enteroscopy is a simplification of the double balloon method. Aim of the study was to compare the rate of complete enteroscopy of these two methods.

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Brief Summary in Scientific Language

Until only a few years ago, it was not possible to access most of the small bowel using endoscopic techniques that avoided the need for surgery. Video capsule endoscopy and balloon enteroscopy thus represent decisive breakthroughs in this field. Balloon enteroscopy using the double or single ballon technique is a more invasive procedure in comparison with capsule endoscopy. However, it provides all the advantages of conventional endoscopy. In optimal cases, the entire small bowel, or at least considerable proportions of it, can be visualized using balloon enteroscopy. Depending on the endoscopist's level of experience, the rate of complete enteroscopy using the double-balloon method is around 40% to 80%. With single-balloon enteroscopy, the rates are currently 12 % to 25%. In 2001, the double-balloon enteroscopy (DBE) system developed by Dr. Yamamoto was presented for the first time in Japan, and in 2003 by our own research group in Germany. In the meantime, the system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now being used universally in clinical routine work. In addition to the classic indication for small-bowel endoscopy, the DBE technique has a variety of other potential uses as well ? e.g., in difficult colonoscopies, or for access to the pancreatic and biliary tract in patients with a surgically modified gastrointestinal tract, and for access to the stomach in patients who have undergone obesity surgery. Another balloon enteroscopy system was recently introduced that is equipped with only one balloon at the tip of the overtube and is therefore known as single-balloon enteroscopy (SBE). The single balloon enteroscopy is a simplification of the double balloon method and has already proved its value in difficult colonoscopy.The question, whether these results can be applied to the more complex situation in the small bowel, has not been answered yet. Therefore this prospective randomised multicenter study comparing the double and single balloon technique was carried out.

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Organizational Data

  •   DRKS00000091
  •   2009/03/02
  •   [---]*
  •   yes
  •   Approved
  •   lfd. Nr. 56/2007, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   expected or proved pathologie of the small bowel
  •   C17 -  Malignant neoplasm of small intestine
  •   K50.0 -  Crohn's disease of small intestine
  •   K55.8 -  Other vascular disorders of intestine
  •   D12.6 -  Benign neoplasm: Colon, unspecified
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Interventions/Observational Groups

  •   double ballon enteroscopy
  •   single ballon enteroscopy
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Characteristics

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

complete enteroscopy

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/09/29
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria had been suspected or known small bowel disorder for diagnostic balloon enteroscopy or therapeutic enteroscopy with argon plasma coagulation of up to 5 angiodysplasias.

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Exclusion Criteria

Exclusion criteria had been age under 18 years, pregnancy, coagulation disorders (thrombocytes < 100000/ml, Quick < 60%, PTT > 50 s), prior surgery of the small bowel and colon, scheduled therapeutic interventions like polypectomy, dilation of stenoses and argon plasma coagulation of more than 5 angiodysplasias or foreign body extraction. Therapeutic balloon enteroscopies had been excluded, because the time needed for treatment cannot be used for further advance to achieve complete enteroscopy.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    • Klinik für Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    • Klinik für Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Mr.  Dr. med.  Michael  Färber 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Horst-Schmidt-Kliniken Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/12/19
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Trial Publications, Results and other Documents

  •   [---]*
  •   Background: DBE has become established throughout the world for diagnostic and therapeutic small bowel endoscopy. SBE has been introduced as a simplification of the balloon enteroscopy technique.
    Objective/ Study design: Prospective comparison of the double and single ballon technique of small bowel endoscopy. Complete enteroscopy was choosen as study endpoint, because it is the most objective parameter. DBE was considered to reach more than double a complete enteroscopy compared to SBE (40% versus 15%). Number of patients needed to be investigated for this hypothesis was calculated with 98 randomised patients. Only diagnostic or therapeutic examinations with argon plasma coagulation up to 5 angiodysplasias were included. Patients with prior colon and small bowel surgery had been excluded.
    Material and Methods: 117 pats. had been enrolled into the study, after exclusion of 17 patients (e.g. due to tumor stenosis, necessary therapeutic interventions etc.) 100 pats. (50 for each group) (63 male, 37 female) with a mean age of 55 years finished the study successfully. Reason for small bowel endoscopy had been (suspected) mid GI bleeding (n=60), (suspected) Crohn`s disease (n= 12), suspected small bowel masses (n=7) and others (n=21). For small endoscopy the Fujinon device (EN450-P5) was used either with two or with one balloon.
    Results: All balloon enteroscopies had been performed without severe complications. The preparation time of the SBE device had been significantly (p<0.0001) faster compared with the DBE device. There was no significant difference regarding the investigation time. Complete enteroscopy was done with the DBE device in 66 % (33 patients) either with the oral route alone or with combination of oral and anal approach, whereas with the SBE device the rate was significantly (p<0.0001) less with 22% (11 patients, only combination of oral and anal route). The diagnostic yield regarding relevant findings had been 50% using DBE and 42% using SBE. Not included in this diagnostic yield rate are the normal examinations for exclusion of relevant findings or determination of the extension of a known disease, where only a complete small bowel endoscopy can give this important information.
    Conclusion: With the DBE technique the rate of complete enteroscopy had been approximately three fold higher than with the SBE technique going along with a higher diagnostic yield. Therefore DBE must continue to be regarded as the gold standard procedure for deep small bowel endoscopy.
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* This entry means the parameter is not applicable or has not been set.