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