Status:
UNKNOWN
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
Lead Sponsor:
CAMC Health System
Collaborating Sponsors:
University of Kentucky
National Center for Research Resources (NCRR)
Conditions:
Gallbladder Dyskinesia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-s...
Detailed Description
Willing and eligible patients will be enrolled into the trial and randomized to surgical vs non-surgical treatment following informed consent. The following information will be collected over the next...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with other known sources of chronic abdominal pain (ex: Crohn's disease) Patients with chronic narcotic use which will affect the reproducibility and validity of the CCK-HIDA results Patient with a history of allergy to amitriptyline Patients with a seizure disorder
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02195115
Start Date
February 1 2014
End Date
July 1 2015
Last Update
March 5 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304