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

Gallbladder Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195115
• Other study ID #: ULJRR033173
• Secondary ID: U54GM104942
• Status: Recruiting
• Phase: Phase 2
• First received: July 17, 2014
• Last updated: March 4, 2015
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: CAMC Health System
• Contact: Jerri Walker
• Phone: 304-388-9995
• Email: jerri.walker[@]CAMC.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Dyskinesia
• Dyskinesias
• Gallbladder Dyskinesia

Intervention

Procedure:
• Laparoscopic Cholecystectomy

Drug:
• amitriptyline

Other:
• low-fat and low cholesterol diet

Locations

Country	Name	City	State
United States	Charleston Area Medical Center	Charleston,	West Virginia

Sponsors (5)

Lead Sponsor	Collaborator
CAMC Health System	National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	No
Secondary	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.	18 months	No