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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gallbladder Dyskinesia
• Intervention / Treatment: Procedure: Laparoscopic Cholecystectomy; Drug: amitriptyline; Other: low-fat and low cholesterol diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jerri Walker; Phone Number: 304-388-9995; Email: jerri.walker@CAMC.org

Study Locations

• United States
  • West Virginia
    • Charleston,, West Virginia, United States, 25304
      • Recruiting
      • Charleston Area Medical Center
      • Principal Investigator: Bryan K Richmond, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CAMC Health System
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS); National Center for Research Resources (NCRR); University of Kentucky
• Investigators: Principal Investigator: Bryan K Richmond, MD, West Virginia University, Charleston Division ; Professor of Surgery

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Dyskinesias; Biliary Dyskinesia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Amitriptyline
• Other Study ID Numbers: ULJRR033173; U54GM104942 (U.S. NIH Grant/Contract)