The Optimal Measurement Time for the New Gallbladder Function Assessment Method

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province

About this trial

This is a multicenter, prospective, randomized, double-blind, crossover study involving healthy individuals, aiming to evaluate the stability of oral protein bars + olive oil as a new method for determining gallbladder contraction function and its optimal diagnostic time window.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ultrasound assessment identifies people with normal biliary tract structure.

Disqualifiers

History of Endoscopic Retrograde Cholangiopancreatography

Previous gallstone removal surgery with gallbladder preservation

Other biliary tract diseases and related surgical history

History of acute or chronic pancreatitis

Trial design

Design model

Crossover

Treatments tested in this trial

  • oral administration of 2 fried eggs

    Dietary supplement

    First, the intervention of oral administration of 2 fried eggs is carried out. The size of the gallbladder is evaluated by ultrasound examination. The washout period is 1 week. After that, the first intervention process of group B is repeated.

  • oral protein bars + 50ml olive oil

    Dietary supplement

    First, an intervention with oral protein bars + 50ml olive oil is conducted. The size of the gallbladder is evaluated through ultrasound examination. The washout period is 1 week. After that, the first intervention process of Group A is repeated.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: fried eggsExperimental treatment 1 intervention
Group B: protein barsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gallbladder Volume

Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52). Measurements were taken every 20 minutes starting from 30 minutes after the intervention, with a total of 5 measurements (i.e., the gallbladder volume was measured at 30 minutes, 50 minutes, 70 minutes, 90 minutes, and 110 minutes respectively).

Time frame
during procedure
2

Gallbladder contraction rate

Subtract the volume of the gallbladder after intervention from the volume of the gallbladder on an empty stomach, then divide by the volume of the gallbladder on an empty stomach, and finally multiply by A-B/A%. The gallbladder contraction rate was calculated at all the above time points.

Time frame
during procedure

Secondary outcomes

1

Presence of Abdominal

Pain Post-Intervention If abdominal pain is present, it will be assessed using the Numerical Rating Scale (NRS) within 0-10, The higher the score, the more serious it is.

Time frame
30 days
2

Occurrence of Acute Pancreatitis

Post-Intervention Pain and Amy 3 times as normal.

Time frame
30 days
3

Occurrence of Gastrointestinal Bleeding Post-Intervention

Black stool or decrease of hemoglobin.

Time frame
30 days

Other outcomes

Sponsors and contacts

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