Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

Abdominal Pain Clinical Trial

— EFRAIM  

Official title:

Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01080690
• Other study ID #: 01102
• 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

• Abdominal Pain

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