NCT02195115

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 5, 2015

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

July 17, 2014

Last Update Submit

March 4, 2015

Conditions

Gallbladder Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rome III Criteria

    18 months

Study Arms (2)

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

surgical removal of gallbladder

Procedure: Laparoscopic Cholecystectomy

Non-operative treatment

ACTIVE COMPARATOR

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

Drug: amitriptylineOther: low-fat and low cholesterol diet

Interventions

Laparoscopic CholecystectomyPROCEDURE
Laparoscopic cholecystectomy
amitriptylineDRUG
Non-operative treatment
low-fat and low cholesterol dietOTHER
Non-operative treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

RECRUITING

MeSH Terms

Conditions

Biliary Dyskinesia

Interventions

Cholecystectomy, LaparoscopicAmitriptylineDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical ProceduresDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Bryan K Richmond, MD

    West Virginia University, Charleston Division ; Professor of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerri Walker

CONTACT

304-388-9995jerri.walker@CAMC.org

Kristi Sutphin

CONTACT

304-388-9945kristi.sutphin@camc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 5, 2015

Record last verified: 2014-07

Locations

US(1)