Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CAMC Health System
• Collaborators: National Center for Research Resources (NCRR); National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH); University of Kentucky
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

Inclusion Criteria:

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 Criteria:

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