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

Primary Purpose

Gallbladder Dyskinesia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy
amitriptyline
low-fat and low cholesterol diet
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Dyskinesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charleston Area Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic cholecystectomy

Non-operative treatment

Arm Description

surgical removal of gallbladder

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

Outcomes

Primary Outcome Measures

SF-8
Administration of SF-8 (health questionnaire) survey prior to the initiation of treatment and periodically after the initiation of treatment to assess the ability of cholecystectomy to provide durable symptomatic relief.

Secondary Outcome Measures

Rome III Criteria
Comparison of the results of surgery to those of non-surgical treatment based on degree of relief of symptoms described in the Rome III criteria and follow-up SF-8 scores.

Full Information

First Posted
July 17, 2014
Last Updated
March 4, 2015
Sponsor
CAMC Health System
Collaborators
University of Kentucky, National Center for Research Resources (NCRR), National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02195115
Brief Title
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
Official Title
Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAMC Health System
Collaborators
University of Kentucky, National Center for Research Resources (NCRR), National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 18 months: age,race, sex, baseline and follow-up quality of life quationnaire scores, a complete medical history, including co-morbid illnesses, medications and surgical history, and a complete assessment of symptoms, including disease specific symptoms against the Rome III criteria for functional gallbladder disorder. Patients randomized to surgery will be referred for immediate laparoscopic cholecystectomy. Patients in the non-surgical management group will be counseled on maintenance of a low-fat diet, and provided with a prescription for amitriptyline 25mg once daily. Patients with persistent, non responsive symptoms that fail to respond to at least one week of administration of amitriptyline will be allowed to voluntarily, cross over into the surgically treated group. After randomization, certain data collection points will be unique to the two groups. These are as follows and are in addition to the general data which will be collected from both groups: Surgery group: operative/pathology findings & operative complications Non-surgical group: Patients will be asked to maintain a food diary and a symptom diary. Patients will be asked to report any medication related side effects. Both groups will receive a phone call for assessment of conditions. Non-surgical groups will be asked to report any medication related side effects. Follow-up for both groups will continue throughout the 18 month period. In addition to the monthly calls, Patients will be contacted every three months after their initial treatment to take the SF-8 questionnaire and obtain an assessment of symptoms using the Rome III criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
surgical removal of gallbladder
Arm Title
Non-operative treatment
Arm Type
Active Comparator
Arm Description
Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Type
Drug
Intervention Name(s)
amitriptyline
Intervention Type
Other
Intervention Name(s)
low-fat and low cholesterol diet
Primary Outcome Measure Information:
Title
SF-8
Description
Administration of SF-8 (health questionnaire) survey prior to the initiation of treatment and periodically after the initiation of treatment to assess the ability of cholecystectomy to provide durable symptomatic relief.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Rome III Criteria
Description
Comparison of the results of surgery to those of non-surgical treatment based on degree of relief of symptoms described in the Rome III criteria and follow-up SF-8 scores.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerri Walker
Phone
304-388-9995
Email
jerri.walker@CAMC.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristi Sutphin
Phone
304-388-9945
Email
kristi.sutphin@camc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan K Richmond, MD
Organizational Affiliation
West Virginia University, Charleston Division ; Professor of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charleston Area Medical Center
City
Charleston,
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan K Richmond, MD

12. IPD Sharing Statement

Learn more about this trial

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

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