Common Bile Duct CalculiNCT02349568
The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones
An observational study of Common Bile Duct Calculi, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- High risk group and Intermediate risk group
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteThailand
- Study dates
- May 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed tomography..
Who may be able to join
- 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.
Who cannot join
- unstable hemodynamics
- severe coagulopathy
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Thailand1 site
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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.
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.
Read the 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.
- Conditions
- Common Bile Duct Calculi
- Being tested
- High risk group, Intermediate risk group
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High risk groupProcedure or surgery
Also called EUS examination follow by ERCP
Patients with high risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. All patients even if negative EUS examination of CBD stone were underwent ERCP in the same session. The ERCPs were performed in standard manner. All patients were contacted by phone on day 1, 3 and 30 after the procedure.
Intermediate risk groupProcedure or surgery
Also called EUS examination follow by ERCP or clinical follow up
Patients with intermediate risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. ERCPs were done at the discretion of the attending physicians. The ERCPs were performed in standard manner. The patients without ERCP done were contacted at 3 months interval to assess symptoms and LFT for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| High risk group | High risk group was defined when CBD stones was detected by ultrasound ( US ) / computed tomography ( CT ) or dilated duct with abnormal LFT. Receives: Procedure: High risk group | |
| Intermediate risk group | Intermediate risk group was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT. Receives: Procedure: Intermediate risk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cost of making diagnosis of CBD stone
The cost of making diagnosis of CBD stone will be measured as the difference in the cost of all patients undergoing ERCP and ERCP follow by EUS intervention. 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) costs associated with complications induced by the procedure.
Measured: within 12 months after EUS
Secondary outcomes (2)
The accuracy of EUS in diagnosis of CBD stone
This will be measured as proportion of patients who encounter a correctly diagnosis of CBD stone by EUS. Positive EUS finding was confirmed by ERCP. Negative EUS finding was confirmed by ERCP or absence of symptoms for 12 months.
Measured: within 12 months after EUS
The safety of EUS and ERCP procedure
This will be measured as proportion of patients who encounter a procedural complication (%) during EUS and ERCP that includes pancreatitis, perforation or hemorrhage
Measured: within 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Bancha Ovartlarnporn, MD, Study director, NKC Institue of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkla, Thailand.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349568
- Sponsor's protocol ID
- EC-55-066-21-1-2
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02349568
- Acronym / sponsor ID
- EC-55-066-21-1-2
- Conditions
- Common Bile Duct Calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk group | – | Procedure: High risk groupHigh risk group was defined when CBD stones was detected by ultrasound ( US ) / computed tomography ( CT ) or dilated duct with abnormal LFT. |
| Intermediate risk group | – | Procedure: Intermediate risk groupIntermediate risk group was defined when US/CT showed normal bile duct with abnormal LFT or dilated duct with normal LFT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected CBD stones based on clinical, biochemical and imaging by trans-abdominal ultrasonography or computed tomography..
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- unstable hemodynamics
- severe coagulopathy
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High risk groupAlso: EUS examination follow by ERCPPatients with high risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. All patients even if negative EUS examination of CBD stone were underwent ERCP in the same session. The ERCPs were performed in standard manner. All patients were contacted by phone on day 1, 3 and 30 after the procedure. | Procedure or surgery | High risk group |
| Intermediate risk groupAlso: EUS examination follow by ERCP or clinical follow upPatients with intermediate risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. ERCPs were done at the discretion of the attending physicians. The ERCPs were performed in standard manner. The patients without ERCP done were contacted at 3 months interval to assess symptoms and LFT for 12 months. | Procedure or surgery | Intermediate risk group |
Primary outcome
The cost of making diagnosis of CBD stone
Time frame: within 12 months after EUS
The cost of making diagnosis of CBD stone will be measured as the difference in the cost of all patients undergoing ERCP and ERCP follow by EUS intervention. 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) costs associated with complications induced by the procedure.
2 secondary outcomes
The accuracy of EUS in diagnosis of CBD stone
Time frame: within 12 months after EUS
The safety of EUS and ERCP procedure
Time frame: within 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bancha Ovartlarnporn, MD study director
NKC Institue of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkla, Thailand.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Calculi, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cost of making diagnosis of CBD stone (time frame: within 12 months after EUS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.