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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01080690
Other study ID # 01102
Secondary ID
Status Recruiting
Phase N/A
First received January 27, 2010
Last updated March 3, 2010
Start date January 2010
Est. completion date December 2010

Study information

Verified date February 2010
Source Technische Universität München
Contact Valentin Becker, Dr.
Phone +49 89 41400
Email valentin.becker@lrz.tum.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.

Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.

Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.

Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute right side abdominal pain

- willing participate study

Exclusion Criteria:

- acute disease

- malignancy

- other disease which might cause discomfort

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
EGD
In this arm EGD will be performed before EUS.
EUS
In this arm EUS will be performed before EGD.

Locations

Country Name City State
Germany Klinikum r.d. Isar, Technical University Munich Munich

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS. within the first week of complaints Yes
Secondary Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography. one year Yes
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