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Trial record 1 of 1 for:    "Biliary Dyskinesia" | "Analgesics, Non-Narcotic"
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Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

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ClinicalTrials.gov Identifier: NCT02195115
Recruitment Status : Unknown
Verified July 2014 by CAMC Health System.
Recruitment status was:  Recruiting
First Posted : July 21, 2014
Last Update Posted : March 5, 2015
Sponsor:
Collaborators:
University of Kentucky
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
CAMC Health System

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.

Condition or disease Intervention/treatment Phase
Gallbladder Dyskinesia Procedure: Laparoscopic Cholecystectomy Drug: amitriptyline Other: low-fat and low cholesterol diet Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
Study Start Date : February 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Laparoscopic cholecystectomy
surgical removal of gallbladder
Procedure: Laparoscopic Cholecystectomy
Active Comparator: Non-operative treatment
Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet
Drug: amitriptyline
Other: low-fat and low cholesterol diet



Primary Outcome Measures :
  1. SF-8 [ Time Frame: 18 months ]
    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 :
  1. Rome III Criteria [ Time Frame: 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195115


Contacts
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Contact: Jerri Walker 304-388-9995 jerri.walker@CAMC.org
Contact: Kristi Sutphin 304-388-9945 kristi.sutphin@camc.org

Locations
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United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston,, West Virginia, United States, 25304
Principal Investigator: Bryan K Richmond, MD         
Sponsors and Collaborators
CAMC Health System
University of Kentucky
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Bryan K Richmond, MD West Virginia University, Charleston Division ; Professor of Surgery

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Responsible Party: CAMC Health System
ClinicalTrials.gov Identifier: NCT02195115     History of Changes
Other Study ID Numbers: ULJRR033173
U54GM104942 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: July 2014
Additional relevant MeSH terms:
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Biliary Dyskinesia
Analgesics, Non-Narcotic
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants