A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound

NCT07039864 | Completed

• 1 other identifier: Gallbladder Function
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-center, single-blind, cross-over trial conducted at a tertiary hospital, aiming to determine the evaluation of oral functional fatty acids on gallbladder contractile function.

Conditions

Gallbladder; Functional Disturbance

Keywords

Gallbladder; Function; Ultrasound; Fatty Acids

Outcome Measures

Primary Outcomes (2)

• Gallbladder Volume

  Ultrasound will be used to measure the volume of the gallbladder on the empty stomach and after the intervention. Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52)

  1 day

• Gallbladder contraction rate

  The volume of the gallbladder on an empty stomach minus the volume of the gallbladder after the intervention, divided by the volume of the gallbladder on an empty stomach, and finally multiplied by 100%（A-B/A%） Gallbladder contraction rate after 1 hour of oral administration of functional fatty acids with Complete gallbladder emptying100% or Good gallbladder contractility50% or Abnormal gallbladder contractility0%

  1 day

Secondary Outcomes (4)

• Presence of Abdominal Pain Post-Intervention

  7 days

• Occurrence of Acute Pancreatitis Post-Intervention

  7 days

• Occurrence of Gastrointestinal Bleeding Post-Intervention

  7 days

• Nausea, Vomiting, and Diarrhea Post-Intervention

  7days

Study Arms (2)

Accept A processing first, then accept B processing, One week interval

EXPERIMENTAL

A processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately take one protein bar orally, and then take 50 milliliters of functional fatty acids orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours.

Diagnostic Test: protein bar first

Accept B processing first, then accept A processing, One week interval

ACTIVE COMPARATOR

B processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately ingest two fried eggs orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours.

Diagnostic Test: fried eggs first

Interventions

protein bar first DIAGNOSTIC_TEST

Take protein bar(after one week fried eggs intake) to evaluate the size of the gallbladder with ultrasound

Accept A processing first, then accept B processing, One week interval

fried eggs first DIAGNOSTIC_TEST

Take fried eggs (after one week protein bar intake) to evaluate the size of the gallbladder with ultrasound

Accept B processing first, then accept A processing, One week interval

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ultrasound assessment identifies people with normal biliary tract structure

You may not qualify if:

• History of Endoscopic Retrograde Cholangiopancreatography
• Previous gallstone removal surgery with gallbladder preservation
• History of acute or chronic pancreatitis, cholangitis
• Mirizzi Syndrome
• History of gastrointestinal surgery
• Gastrointestinal obstruction
• Dysfunction of the sphincter of Oddi
• Gallbladder neck polyps
• Abnormal gallbladder structure
• Gallbladder mass
• Biliary infection or stones
• Congenital biliary abnormalities
• Biliary injury or surgery
• Biliary tumors
• Gastrointestinal bleeding, liver cirrhosis, or other malignant diseases

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (2)

• Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022.

  PMID: 35910468 RESULT

• Deinega VG, Medvedev VV, Polishchuk LM. [The evaluation of gallbladder contractile function and the ultrasonic signs of chronic noncalculous cholecystitis]. Lik Sprava. 1992 Jun;(6):103-6. Russian.

  PMID: 1455813 RESULT

Study Officials

• Wenbo Meng, M.D. Ph. D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 26, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)