Improvement of Diagnostic Approach Using PoCUS for Right Upper Quadrant Abdominal Pain

NCT05438654 | Completed

• 1 other identifier: DARUQUS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). In daily practice, abdominal pain accounts for 7% to 10% of emergency department consultations, while the mean reported prevalence of abdominal pain in family physician consultations is 2.8%. PoCUS can be used in a variety of ways during abdominal physical examinations, and most scientific societies encourage its use to address a specific clinical question rather than provide a diagnosis, which is usually confirmed by comprehensive ultrasound in radiology. The integration of PoCUS into clinical examination raises the issue of PoCUS accuracy to improve the diagnostic approach as opposed to PoCUS diagnostic accuracy itself. Considering the wide range of differential diagnoses associated with right upper quadrant pain, this multicenter prospective study protocol aims to evaluate the improvement of the diagnostic approach using PoCUS in patients presenting at an emergency department with right upper quadrant abdominal pain. In light of the final diagnosis at 1-month follow-up, two members of an adjudication committee will blindly choose between two case report forms: one filled in before PoCUS and the other completed after the use of PoCUS by the investigator in charge of a patient suffering from right upper quadrant abdominal pain. The hypothesis that PoCUS enhances diagnostic approaches by 18% will be reached if 74.8% of the better diagnostic approaches are in favor of the case report form filled in after PoCUS.

Conditions

Abdominal Pain

Keywords

Point of Care Ultrasound; Right upper quadrant abdominal pain

Outcome Measures

Primary Outcomes (1)

• Change in diagnostic approach before and after the use of point of care ultrasound

  Rate of diagnostic approach considered improved after intervention by the adjudication committee Two independent members of an adjudication committee will evaluate two diagnostic approaches (before and after PoCUS) reported in the case report forms (CRFs) of patients suffering from right upper quadrant abdominal pain in an emergency setting while considering the final diagnosis determined at 1-month follow-up. As the adjudication committee members are blind to the intervention, they do not know which diagnostic approach reported in the CRFs is performed before or after PoCUS. For each patient file, the adjudication committee must choose the better diagnostic approach or state that the diagnostic approach is unchanged.

  through study completion, at an average of 7 months

Secondary Outcomes (8)

• PoCUS influence on the choice of complementary examination(s)

  through study completion, at an average of 7 months

• Comparison of the absolute number of complementary examination planned before and after intervention

  through study completion, at an average of 7 months

• PoCUS influence on the physicians' coefficient of certainty regarding the diagnostic approach

  through study completion, at an average of 7 months

• PoCUS influence on the physicians' coefficient of certainty regarding the differential diagnosis

  through study completion, at an average of 7 months

• PoCUS influence on the physicians' coefficient of certainty regarding the initiated treatment

  through study completion, at an average of 7 months

Study Arms (1)

Cohort of patients presenting to emergency department with abdominal right upper quadrant pain

OTHER

This study is a single arm study analyzing a prospective population of patients presenting at the emergency department complaining of non-traumatic right upper quadrant abdominal pain. The analysis of the diagnostic approach will take place before and after the intervention on a same patient. The intervention is the use of Point of Care Ultrasound bedside.

Diagnostic Test: Point of care ultrasound

Interventions

Point of care ultrasound DIAGNOSTIC_TEST

Abdominal PoCUS use according to the following protocol: PoCUS assessment of the right lung base PoCUS assessment of Morrison's pouch PoCUS assessment of gallbladder PoCUS assessment of right kidney (comparison to left kidney acceptable) PoCUS assessment of small bowel

Cohort of patients presenting to emergency department with abdominal right upper quadrant pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 17 years
• Right upper quadrant abdominal pain \< 11 days
• Signed informed consent

You may not qualify if:

• Any reason that prevents ultrasound use
• Pregnancy
• Palliative care status or poor prognosis at 1-month follow-up
• Impossibility of 1-month follow-up
• Insufficient knowledge of French or Dutch to understand the informed consent
• Lost to follow-up
• Previously unknown pregnancy diagnosed during the emergency department consultation
• Emergency of care deemed incompatible with the study process by the investigator

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires saint luc

Brussels, 1200, Belgium

Location

Related Publications (22)

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MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Florence Dupriez, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In light of final diagnosis, an adjudication committee will evaluate the best diagnostic approach, blind to intervention for each patient.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of patients suffering from right upper quadrant abdominal pain will undergo the intervention (Point of care ultrasound of the right upper quadrant). Diagnostic approach will be registered on a case report form (part 1 and part 2) before and after the intervention on a patient. In light of final diagnosis, an adjudication committee will then evaluate the best diagnostic approach, blind to intervention for each patient.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 30, 2022
• Study Start: September 1, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)