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

T

Technical University of Munich

Status

Unknown

Conditions

Abdominal Pain

Treatments

Procedure: EUS
Procedure: EGD

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • acute right side abdominal pain
  • willing participate study

Exclusion criteria

  • acute disease
  • malignancy
  • other disease which might cause discomfort

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups

EGD
Active Comparator group
Description:
In this arm EGD will be performed before EUS
Treatment:
Procedure: EGD
EUS
Active Comparator group
Description:
In this arm, EUS will be performed before EGD.
Treatment:
Procedure: EUS

Trial contacts and locations

1

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Central trial contact

Valentin Becker, Dr.

Data sourced from clinicaltrials.gov

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