CholedocholithiasisNCT03658863
"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis
A study testing endoscopic ultrasound, intraoperative cholangiography and ERCP in people with Choledocholithiasis, run by Vilnius University at 1 site in Lithuania.
Trial summary
The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- endoscopic ultrasound, intraoperative cholangiography and ERCP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Dec 2017to 15 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated
- intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound)
Who cannot join
- pregnancy;
- acute cholangitis;
- biliary pancreatitis;
- acute cholecystitis, degree II-III by Tokyo guidelines 2013;
- anastomosis in upper gastrointestinal tract;
- other known cholestatic hepatopancreatobiliary disease;
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- known or suspected hepatitis of another origin (viral, toxic, etc.);
- contraindications for general anaesthesia or surgery;
- IV-VI class of American Society of Anesthesiologists physical status classification;
- morbid obesity (body mass index > 40);
- patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Gintaras Simutis, MD, PhD, +370 5 236 5255, gintaras.simutis@santa.lt
Ausra Aleknaite, MD, +370 618 18076, ausra.aleknaite@santa.lt
About this study
Official title: Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated.
Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.
Read the detailed description
Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed.
At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.
- Conditions
- Choledocholithiasis
- Being tested
- endoscopic ultrasound, intraoperative cholangiography, ERCP, Ultrasound endoscope
- Keywords
- choledocholithiasis, endoscopic ultrasound, ERCP, intraoperative cholangiography, common bile duct stone, endoscopic retrograde cholangiopancreatography, gallstone disease, cholelithiasis, bile duct obstruction, laparoscopic cholecystectomy
- Medical subject headings
- Choledocholithiasis, Gallstones, Cholelithiasis, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasoundProcedure or surgery
Evaluation of bile ducts with endoscope with special ultrasonographic function
intraoperative cholangiographyProcedure or surgery
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
ERCPProcedure or surgery
Also called endoscopic retrograde cholangiopancreatography
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Ultrasound endoscopeDevice
Also called Endosonoscope
Endoscope with built-in ultrasound function
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy first | Active comparator | Endoscopic ultrasound is used to evaluate bile ducts. If stones in extrahepatic bile ducts are seen ERCP and stone evacuation is performed during the same anaesthesia. Laparoscopic cholecystectomy is performed after endoscopic procedures in two days. Receives: Procedure: endoscopic ultrasound; Procedure: ERCP; Device: Ultrasound endoscope |
| Cholecystectomy first | Active comparator | Laparoscopic cholecystectomy with intraoperative cholangiography is performed. If stones are found postoperative ERCP with stone evacuation is applied (during cholecystectomy if common bile duct is completely blocked or as soon as possible). Receives: Procedure: intraoperative cholangiography; Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment
duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days
Measured: up to one month
Secondary outcomes (4)
Accuracy of different management strategies
Proportion of correctly diagnosed (true positive and true negative) cases in all sample
Measured: 6 to 7 months
Technical success of interventions (IOC, EUS, ERCP)
For intraoperative cholangiography: successful cannulation and contrast media injection into CBD.
For endoscopic sonoscopy: successful visualisation of CBD.
For ERCP: successful cannulation and contrast media injection into CBD.
Measured: up to one month
Adverse events of interventions
Bleeding, acute pancreatitis, perforation, allergic reactions
Measured: up to one month
Costs of treatment
charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Dec 2017
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ausra Aleknaite, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658863
- Sponsor's protocol ID
- TLA02
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2018
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aleknaite A, Simutis G, Stanaitis J, Jucaitis T, Drungilas M, Valantinas J, Strupas K. Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837.
PubMed 33538700
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
- ClinicalTrials.gov ID
- NCT03658863
- Acronym / sponsor ID
- TLA02
- Conditions
- Choledocholithiasis
- Keywords
- choledocholithiasis, endoscopic ultrasound, ERCP, intraoperative cholangiography, common bile duct stone, endoscopic retrograde cholangiopancreatography, gallstone disease, cholelithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 5 Sep 2018 (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.
The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated.
Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.
Detailed description
Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed.
At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopy first | Active comparator | Procedure: endoscopic ultrasound, Procedure: ERCP, Device: Ultrasound endoscopeEndoscopic ultrasound is used to evaluate bile ducts. If stones in extrahepatic bile ducts are seen ERCP and stone evacuation is performed during the same anaesthesia. Laparoscopic cholecystectomy is performed after endoscopic procedures in two days. |
| Cholecystectomy first | Active comparator | Procedure: intraoperative cholangiography, Procedure: ERCPLaparoscopic cholecystectomy with intraoperative cholangiography is performed. If stones are found postoperative ERCP with stone evacuation is applied (during cholecystectomy if common bile duct is completely blocked or as soon as possible). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated
- intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound)
Key exclusion criteria (11 listed)
- pregnancy;
- acute cholangitis;
- biliary pancreatitis;
- acute cholecystitis, degree II-III by Tokyo guidelines 2013;
- anastomosis in upper gastrointestinal tract;
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 |
|---|---|---|
| endoscopic ultrasoundEvaluation of bile ducts with endoscope with special ultrasonographic function | Procedure or surgery | Endoscopy first |
| intraoperative cholangiographyevaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy | Procedure or surgery | Cholecystectomy first |
| ERCPAlso: endoscopic retrograde cholangiopancreatographyevaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum | Procedure or surgery | Cholecystectomy first, Endoscopy first |
| Ultrasound endoscopeAlso: EndosonoscopeEndoscope with built-in ultrasound function | Device | Endoscopy first |
Primary outcome
Duration of treatment
Time frame: up to one month
duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days
4 secondary outcomes
Accuracy of different management strategies
Time frame: 6 to 7 months
Technical success of interventions (IOC, EUS, ERCP)
Time frame: up to one month
Adverse events of interventions
Time frame: up to one month
Costs of treatment
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Derived from this study: PubMed 33538700Aleknaite A, Simutis G, Stanaitis J, Jucaitis T, Drungilas M, Valantinas J, Strupas K. Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837.
- Individual participant dataSharing planned: Undecided
Related trials for Choledocholithiasis
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Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
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Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound, intraoperative cholangiography and ERCP in people with Choledocholithiasis, run by Vilnius University at 1 site in Lithuania.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Oct 2019. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of treatment (time frame: up to one 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 NCT03658863, 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 7 Oct 2019.