Recruiting
Phase 2

Laparoscopic Cholecystectomy vs. Non-operative Treatment

Sponsor:

CAMC Health System

Code:

NCT02195115

Conditions

Gallbladder Dyskinesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laparoscopic Cholecystectomy

amitriptyline

low-fat and low cholesterol diet

Study Details

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-surgical therapy.

Conditions

Gallbladder Dyskinesia

Study ID

NCT02195115

Start date

Feb, 2014

Status verified date

Jul, 2014

Completion date

Jul, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Laparoscopic cholecystectomy

surgical removal of gallbladder

active comparator: Non-operative treatment

Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet

Interventions

Laparoscopic Cholecystectomy

amitriptyline

low-fat and low cholesterol diet

Primary outcome measure

  • SF-8 [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Jerri Walker

304-388-9995jerri.walker@CAMC.org

Kristi Sutphin

304-388-9945kristi.sutphin@camc.org

Locations

Charleston Area Medical Center

Recruiting

Charleston,, West Virginia, United States, 25304

Principal Investigator:

Bryan K Richmond, MD

More Information

Sponsor

CAMC Health System

Last update posted

Mar 5, 2015

Last verified

Jul, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2015-03-05.