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Laparoscopic cholecystectomy for Gallbladder Dysfunction

Phase 2
Waitlist Available
Led By Bryan K Richmond, MD
Research Sponsored by CAMC Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a normal gallbladder Patients with symptoms compatible with gallbladder dyskinesia (functional gallbladder disorder) as defined by the Rome III criteria Patients with a Cholecystokinin hepatobiliary (CCK-HIDA) scintigraphy gallbladder ejection fraction of <38%, performed at a facility using updated Society of Nuclear Medicaine guidelines for test administration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

The goal of this study is to challenge the existing clinical practice of employing laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a regimen of active non-surgical therapy.

Eligible Conditions
  • Gallbladder Dysfunction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SF-8
Secondary outcome measures
Rome III Criteria

Trial Design

2Treatment groups
Active Control
Group I: Laparoscopic cholecystectomyActive Control1 Intervention
surgical removal of gallbladder
Group II: Non-operative treatmentActive Control2 Interventions
Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet

Find a Location

Who is running the clinical trial?

CAMC Health SystemLead Sponsor
45 Previous Clinical Trials
8,006 Total Patients Enrolled
University of KentuckyOTHER
187 Previous Clinical Trials
226,904 Total Patients Enrolled
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,956 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
2014. "Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02195115.
All > Gallbladder
~5 spots leftby May 2025
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