CholedocholithiasisNCT04173624
To Compare EUS and MRCP in Detecting Choledocholithiasis in Patients of Intermediate Risk of Choledocholithiasis
A study testing Endosonography and Magnetic Resonance Cholangiopancreatography in people with Choledocholithiasis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- Endosonography and Magnetic Resonance Cholangiopancreatography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteIndia
- Study dates
- 3 Dec 2019to 28 Jul 2020
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines
Who cannot join
- Patients with Cholangitis
- Patients with hypotension
- Ultrasound or CT cross sectional image showing stone
- Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
- Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
- Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
Show all 11Show fewer
- Patients with history significant alcohol intake
- Patients taking hepato toxic drugs
- Patients in whom serum hepatitis B or C antibodies are present
- Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
- Patients not giving consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical follow up for negative patients . Furthur validation of EUS Vs MRCP is needed in detecting common bile duct caliculi in intermediate risk of choledocholithiasis To date Randamized control trail comparing EUS Vs MRCP in detecting Choledocholithiasis lacking , hence the investigators aimed a Randamized control trail determining and comparing the sensitivity and specificity of EUS and MRCP in diagnosing Choledocholithiasis.
Read the detailed description
Aim: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
Outcomes
A.Primary Outcome :
•Sensitivity and Specificity of EUS Vs MRCP
B.Secondary Outcomes:
- Cost effectiveness
- Adverse effects
- Additional Clinically Significant endoscopic findings
MATERIAL AND METHODS Study area •out-patients and in-patients in Asian Institute of Gastroenterology Study design Randamized control study Study period November 2019-March 2020
INCLUSION CRITERIA:
•Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines Guidelines
Exclusion criteria:
- Patients with Cholangitis
- Patients with hypotension
- Ultrasound or CT cross sectional image showing stone
- Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
- Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
- Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
- Patients with history significant alcohol intake
- Patients taking hepato toxic drugs
- Patients in whom serum hepatitis B or C antibodies are present
- Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
- Patients not giving consent for participation
STUDY PROCEDURE The study will be a Randomized control study where sensitivity and specificity and secondary outcomes - cost effectiveness, adverse effects will be compared between EUS and MRCP group . All the patients presented to outpatient department or in patient wards with suspected choledocholithiasis will be screened as per European Society of Gastrointestinal Endoscopy guideline. Patients stratified into intermediate probability will be selected based on inclusion and exclusion criteria. Then patients will randomized to either EUS or MRCP based computerized software .Patients who are randomized to EUS group will undergo EUS for detection of Choledocholithiasis and then undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) at same time if calculi detected and patients in whom calculi was not found, management is based on clinical judgement and 3months follow up . Patients who are randomized to MRCP group will undergo MRCP for detection of Choledocholithiasis and then undergo ERCP if calculi detected. Patients in whom calculi was not found, management will be based on clinical judgement and 3 months follow up. Based on presence of or absence of stone in Reference standard i.e in ERCP following EUS or MRCP or during 3 month follow up , sensitivities and specificities of EUS and MRCP are calculated and compared .
- Conditions
- Choledocholithiasis
- Being tested
- Endosonography, Magnetic Resonance Cholangiopancreatography
- Keywords
- EUS, MRCP, Intermediate Probability
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndosonographyDiagnostic test
Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.
Magnetic Resonance CholangiopancreatographyDiagnostic test
Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology
| Study group | Role | What they receive |
|---|---|---|
| Endosonography | Experimental | Endosonography is endoscopic method to diagnose pancreatic and biliary disorders. Participants randomized to this arm will undergo diagnostic endosonography under propofol sedation in supervision of trained anesthesiologists. If choledocholithiasis is diagnosed on endosonography, patient will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician. Receives: Diagnostic Test: Endosonography |
| Magnetic Resonance Cholangiopancreatography | Experimental | Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for diagnosis of pancreatic and biliary disorders. Participants randomized to this arm will undergo MRCP. If choledocholithiasis is diagnosed on MRCP, participants will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician. Receives: Diagnostic Test: Magnetic Resonance Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of EUS Vs MRCP
This study will evaluate diagnostic accuracy of MRCP and EUS in patients with intermediate probability of choledocholithiasis as per European society of GI endoscopy guidelines
Measured: 4 month
Secondary outcomes (3)
Rate of Adverse Events
Adverse events related with EUS and MRCP will be collected. Those who undergo ERCP for choledocholithiasis, total adverse events related to ERCP will be collected.
Measured: 4 month
Cost - Effectiveness
Cost benefits analysis for EUS Vs MRCP will be done for detection of choledocholithiasis by using total cost along with direct and indirect cost.
Measured: 4 months
Rate of Additional Significant Endoscopic finding
In Endosonography arm, total additional endoscopic clinically significant findings such as ulcer, polyps, esophageal and gastric varies, gastric outlet obstruction will be collected.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start3 Dec 2019
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh K, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173624
- Sponsor's protocol ID
- EUS Vs MRCP-01
- Status last verified
- Aug 2020
- First submitted
- 19 Nov 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jagtap N, Kumar JK, Chavan R, Basha J, Tandan M, Lakhtakia S, Kalapala R, Nabi Z, Gupta R, Ramchandani M, Talukdar R, Reddy M, Yarlagadda R, Singh J, Memon SF, Venkat Rao G, Reddy DN. EUS versus MRCP to perform ERCP in patients with intermediate likelihood of choledocholithiasis: a randomised controlled trial. Gut. 2022 Feb 10:gutjnl-2021-325080. doi: 10.1136/gutjnl-2021-325080. Online ahead of print.
PubMed 35144973
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04173624
- Acronym / sponsor ID
- EUS Vs MRCP-01
- Conditions
- Choledocholithiasis
- Keywords
- EUS, MRCP, Intermediate Probability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 22 Nov 2019 (actual)
- 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.
A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical follow up for negative patients . Furthur validation of EUS Vs MRCP is needed in detecting common bile duct caliculi in intermediate risk of choledocholithiasis To date Randamized control trail comparing EUS Vs MRCP in detecting Choledocholithiasis lacking , hence the investigators aimed a Randamized control trail determining and comparing the sensitivity and specificity of EUS and MRCP in diagnosing Choledocholithiasis.
Detailed description
Aim: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
Outcomes
A.Primary Outcome :
•Sensitivity and Specificity of EUS Vs MRCP
B.Secondary Outcomes:
- Cost effectiveness
- Adverse effects
- Additional Clinically Significant endoscopic findings
MATERIAL AND METHODS Study area •out-patients and in-patients in Asian Institute of Gastroenterology Study design Randamized control study Study period November 2019-March 2020
INCLUSION CRITERIA:
•Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines Guidelines
Exclusion criteria:
- Patients with Cholangitis
- Patients with hypotension
- Ultrasound or CT cross sectional image showing stone
- Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
- Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
- Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
- Patients with history significant alcohol intake
- Patients taking hepato toxic drugs
- Patients in whom serum hepatitis B or C antibodies are present
- Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
- Patients not giving consent for participation
STUDY PROCEDURE The study will be a Randomized control study where sensitivity and specificity and secondary outcomes - cost effectiveness, adverse effects will be compared between EUS and MRCP group . All the patients presented to outpatient department or in patient wards with suspected choledocholithiasis will be screened as per European Society of Gastrointestinal Endoscopy guideline. Patients stratified into intermediate probability will be selected based on inclusion and exclusion criteria. Then patients will randomized to either EUS or MRCP based computerized software .Patients who are randomized to EUS group will undergo EUS for detection of Choledocholithiasis and then undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) at same time if calculi detected and patients in whom calculi was not found, management is based on clinical judgement and 3months follow up . Patients who are randomized to MRCP group will undergo MRCP for detection of Choledocholithiasis and then undergo ERCP if calculi detected. Patients in whom calculi was not found, management will be based on clinical judgement and 3 months follow up. Based on presence of or absence of stone in Reference standard i.e in ERCP following EUS or MRCP or during 3 month follow up , sensitivities and specificities of EUS and MRCP are calculated and compared .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endosonography | Experimental | Diagnostic Test: EndosonographyEndosonography is endoscopic method to diagnose pancreatic and biliary disorders. Participants randomized to this arm will undergo diagnostic endosonography under propofol sedation in supervision of trained anesthesiologists. If choledocholithiasis is diagnosed on endosonography, patient will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician. |
| Magnetic Resonance Cholangiopancreatography | Experimental | Diagnostic Test: Magnetic Resonance CholangiopancreatographyMagnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for diagnosis of pancreatic and biliary disorders. Participants randomized to this arm will undergo MRCP. If choledocholithiasis is diagnosed on MRCP, participants will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines
Key exclusion criteria (11 listed)
- Patients with Cholangitis
- Patients with hypotension
- Ultrasound or CT cross sectional image showing stone
- Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
- Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
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 |
|---|---|---|
| EndosonographyEndosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology. | Diagnostic test | Endosonography |
| Magnetic Resonance CholangiopancreatographyMagnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology | Diagnostic test | Magnetic Resonance Cholangiopancreatography |
Primary outcome
Sensitivity and Specificity of EUS Vs MRCP
Time frame: 4 month
This study will evaluate diagnostic accuracy of MRCP and EUS in patients with intermediate probability of choledocholithiasis as per European society of GI endoscopy guidelines
3 secondary outcomes
Rate of Adverse Events
Time frame: 4 month
Cost - Effectiveness
Time frame: 4 months
Rate of Additional Significant Endoscopic finding
Time frame: 4 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 18 Aug 2020.
- Derived from this study: PubMed 35144973Jagtap N, Kumar JK, Chavan R, Basha J, Tandan M, Lakhtakia S, Kalapala R, Nabi Z, Gupta R, Ramchandani M, Talukdar R, Reddy M, Yarlagadda R, Singh J, Memon SF, Venkat Rao G, Reddy DN. EUS versus MRCP to perform ERCP in patients with intermediate likelihood of choledocholithiasis: a randomised controlled trial. Gut. 2022 Feb 10:gutjnl-2021-325080. doi: 10.1136/gutjnl-2021-325080. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endosonography and Magnetic Resonance Cholangiopancreatography in people with Choledocholithiasis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 1 inclusion and 11 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 18 Aug 2020. 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 India. 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?
Sensitivity and Specificity of EUS Vs MRCP (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173624, which also lists 1 linked publication.
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 18 Aug 2020.