A Strategy for Gallstone Expulsion Through Dietary Therapy

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

About this trial

This study is a double-blind, prospective, single-center controlled trial conducted at a tertiary hospital, aiming to determine whether dietary therapy can effectively expel gallstones.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm

Disqualifiers

History of ERCP (Endoscopic Retrograde Cholangiopancreatography)

Previous gallstone removal surgery with gallbladder preservation

History of acute or chronic pancreatitis, cholangitis

Mirizzi Syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional fatty acids

    Drug

    Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids

  • Placebo

    Other intervention

    Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Functional fatty acidsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with complete expulsion of gallbladder sludge after three days of intervention

Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled

Time frame
7 days
2

2)Number of patients with complete expulsion of gallbladder sludge after six days of intervention

Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled

Time frame
7 days

Secondary outcomes

1

Gallbladder Volume

Measured by ultrasound (L × W × D × 0.52)

Time frame
7 days
2

Gallbladder Wall Thickness

Measured by ultrasound, accurate to 0.1 mm

Time frame
7 days
3

Serum bilirubin

Determined by lab examination within 3.4-17.1μmol/L

Time frame
7 days
4

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
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.