Trial document




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  DRKS00003081

Trial Description

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Title


Prospective registration of patients with duodenal adenomas: endoscopic therapy, complications and duration of remission

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Duodenal adenomas are the majority of the benign tumors of the upper small intestine. Allthough they are classified as benign, they have the potential of malignant tranformation. In most cases duodenal adenomas are asymptomatic.
Concerning the therapy of the duodenal adenomas there is no standard procedure. The consens is to remove the duodenal adnoma endoscopically because of its chance of malignant transformation. The complication rate increases with the size of the adenoma. That is why surgery is done in extreme large adenomas.
Overall there is very few data on the therapy and its complications. Hence, we want to follow up on all out patients with duodenal adenomas (size, description of the adenoma, therapeutical procedure, process) to learn more about the adenomas and assess the advancement of the therapeutic management.

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Brief Summary in Scientific Language

Duodenal adenomas are the majority of the benign tumors of the upper small intestine. Allthough they are classified as benign, they have the potential of malignant tranformation. They mostly occur sporadically or in cases o FAP.
Concerning the therapy of the duodenal adenomas there is no standard procedure. The consens is to remove the duodenal adnoma endoscopically because of its chance of malignant transformation. The complication rate increases with the size of the adenoma.
Overall there is very few data on the therapy and its complications.
Primary target of the study is to clarify the complication rate of endoscopic therapy of duodenal adenomas and to determine which complications occur how often. Secondary criteria are to investigate: a) influence of the complication rate by the type of the adenoma (size, location, histology, pattern) as well as b) type and handling of the endocopic maneuvre (resection en bloc-piece meal-APC-therapy). Furthermore the duration till the complete remission and the duration of the remission itself are of interest.

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Organizational Data

  •   DRKS00003081
  •   2011/05/11
  •   [---]*
  •   yes
  •   Approved
  •   FF 29/2011, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   D13.2 -  Benign neoplasm: Duodenum
  •   D12.6 -  Benign neoplasm: Colon, unspecified
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Interventions/Observational Groups

  •   endoscopic resection of the duodenal adenoma with subsequent registration of complications and duration of remission
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

The goal of the study is the systematic registration of patients with duodenal adnnomas at the Dr. Horst Schmidt Klinik in Wiesbaden. Primary outcome is to clarify the complication rate for endoscopic therapy of duodenal adenomas and to see which complications occure in which frequency

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Secondary Outcome

Secondary outcomes of the study are:
- influence of the complication rate concerning size, location, histology, pattern), type of endocopic therapy (resection en bloc-piece meal-APC-therapy )
- duration till complete remission and duration of remission

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/05/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- age over 18 years
-patients with suspected or diagnosed duodenal adenomas

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Exclusion Criteria

- missing consent
- pregnacy
- Coagulation disorders (Quick <60%, PTT > 50 s, WBC< 100.000/ml)

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Addresses

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    • HSK Wiesbaden
    • Ms.  Prof.  Andrea  May 
    • Ludwig Erhard Str. 100
    • 65193  Wiesbaden
    • Germany
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    • HSK Wiesbaden
    • Ms.  Dr.  Insa  Messer 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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    • HSK Wiesbaden
    • Ms.  Dr.  Insa  Messer 
    • Ludwig Erhard Str. 100
    • 65199  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • HSK Wiesbaden
    • Mr.  Prof.  Christian  Ell 
    • Ludwig ERhard Str. 100
    • 65199  Wiesbaden
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.