Clinical trial NCT02349568: The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones
Official title: The Cost Effectiveness Between EUS-based Strategy Versus Endoscopic Retrograde Cholangiopancreatography ( ERCP )-Based Strategy in Diagnosis of Common Bile Duct Stones in Patients With Intermediate Risk: a Study in Developing Country.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Bile Duct Calculi
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed tomography..

Brief summary: Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous studies. The aim of our study was to assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for CBD stones in a real working situation in a developing country.

Detailed description: Background: Multiple reports showed the efficacy of EUS comparable to ERCP in the diagnosis of CBD stone. The EUS-based strategy has provided the cost saving in diagnosis of CBD stone in patients with intermediate risk in previous studies in western population. There were multiple parameters involved the cost effectiveness analysis included cost of ERCP, cost of EUS, prevalence of CBD stones, the sensitivity and specificity of EUS and the rate of complications related to EUS and ERCP. These parameter may vary from center to center and from region to region.

Aims: To assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risk in a developing country.

Method : A prospective study in 141 patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed abdominal tomography. All patients underwent EUS. All patients with high risk for CBD stone underwent ERCP after the EUS. For patients with intermediate risk for CBD stone, ERCP's were done at the discretion of the attending physicians. For patients with ERCP done, the diagnosis of CBD stone was confirmed by ERCP demonstration of CBD stone. In patients with intermediate risk without ERCP done, clinical follow up to assess biliary symptoms and liver function test as surrogated markers for CBD stone at 3 months interval for one year were done. The false negative rate in patients with EUS and ERCP done in this study was used to estimate the false negative rate in patients in clinical surrogated group.

Definition: High risk of CBD stones was defined when CBD stone was detected by US/CT or dilated duct with abnormal liver function test ( LFT ). Intermediate risk of CBD stones was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT.

Cost analysis :The cost of making diagnosis of CBD stone excluding all costs of treatment was analyzed. The cost of all patients with suspected CBD stones undergoing ERCP was calculated and compared with the strategy of EUS follow by ERCP. The cost was evaluated by (1) mean costs of EUS and ERCP based on the actual cost in our center which included costs of medical staffs, disposable materials, drugs, equipment amortization and maintenance. (2) cost associated with complications induced by the procedure.

Statistical analysis: Test performance of the endoscopic ultrasound in diagnosis of CBD stones was analyzed with two by two tables. The sensitivity, specificity, positive and negative predictive values were calculated.

Eligibility criteria: Inclusion Criteria:

* history of biliary pain or recent cholangitis
* acute pancreatitis
* abnormal liver function test
* dilatation of CBD and or CBD stone detected by trans-abdominal ultrasound and or computed tomography.

Exclusion Criteria:

* unstable hemodynamics
* severe coagulopathy
* refusal to participate

Primary outcomes:
measure: The cost of making diagnosis of CBD stone
timeFrame: within 12 months after EUS
Secondary outcomes:
measure: The accuracy of EUS in diagnosis of CBD stone
timeFrame: within 12 months after EUS
measure: The safety of EUS and ERCP procedure
timeFrame: within 1 months
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: NKC Institue of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkla, Thailand.
name: Bancha Ovartlarnporn, MD
role: STUDY_DIRECTOR
References: