CholedocholithiasisNCT02870686
EUS Guided ERCP in Bile Duct Stone Removal
A study testing ERCP without the use of fluoroscopy and ERCP with the use of fluoroscopy in people with Choledocholithiasis, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- ERCP without the use of fluoroscopy and ERCP with the use of fluoroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to Oct 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had EUS presence of CBDS ≤ 10 mm, and EUS images absence of CBD stricture and CBD narrowing below the stones
Who cannot join
- pregnancy
- concomitant intrahepatic bile duct stones
- malignant bile duct stricture
- altered gastrointestinal anatomy
- instability hemodynamics
- concomitant emergency situation
- unwilling 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: A Prospective Randomized Trial Comparing EUS Guided ERCP Without Fluoroscopy With Standard ERCP in Common Bile Duct Stone Removal
For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is highy accurate technique in detecting common bile duct stone and guiding for therapeutic intervention. There has been a few data from literature showed that EUS guided CBD stone ( CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and complications. This randomized trial is designed to address the question that EUS guided CBDS removal is equivalent to ERCP in term of efficacy and safety.
Read the detailed description
Common bile duct stones (CBDS) can be complicated with various conditions including biliary pain, acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. CBDS should therefore be removed even if patients are asymptomatic.
Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone treatment of CBDS. ERCP is often performed under fluoroscopic guidance. This comprises biliary cannulation whereby the bile duct is achieved with a standard ERCP catheter under fluoroscopy guidance, radiocontrast was injected for confirmation and images of biliary system, location and number of CBDS, biliary sphincterotomy was then performed followed by stone extraction using a standard accessories such as a basket and or balloon. Therefore, the endoscopist, endoscopic staff and patient are potentially exposed to ionizing radiation during ERCP. Endoscopists should always attempt to minimize radiation exposure to the personnel staffs and patients by following the ALARA principle ("As Low As Reasonably Achievable"). ERCP without the use of fluoroscopy is the one method to avoid exposure to radiation. A few retrospective case series have been shown that ERCP can be performed with high success rate without the need for fluoroscopic imaging.
EUS has been proven to have diagnostic accuracy comparable to ERCP in the diagnosis of CBDS, and it's associated with a very low procedure related complications and non-radiation exposure procedure. With EUS performed before ERCP, unnecessary ERCP and its related complications can be avoided in patients without CBDS. In patients with CBDS, the images of pancreaticobiliary tract derived from EUS provide an information regarding the location, size and number of CBDS for guiding therapeutic endoscopy, and allowing a therapeutic ERCP in the same session of sedation. Vohra et al. reported the retrospective case series of EUS - based ERCP in 10 pregnant patients, they have shown that EUS performed prior ERCP can eliminate unnecessary ERCP and achieve in CBDS clearance without the use of fluoroscopy. We have previously reported the use of EUS guided ERCP in the removal of CBDS without fluoroscopy (EGWF) in the pilot study, it showed that EGWF was feasible in selected patients with CBDS. The efficacy of EUS guided ERCP in CBDS removal without fluoroscopy compared with standard ERCP has not been fully assessed. We therefore prospectively investigated the efficacy and safety of EGWF versus ERCP in CBDS removal in a larger patient cohort.
- Conditions
- Choledocholithiasis
- Being tested
- ERCP without the use of fluoroscopy, ERCP with the use of fluoroscopy
- Keywords
- ERCP, EUS guided ERCP without fluoroscopy
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP without the use of fluoroscopyProcedure or surgery
ERCP removal of stone technique without the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with catheter aspiration of bile, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket- number of stones removed should compare number detected on EUS, (5) confirmation of complete stone clearance with radiocontrast.
ERCP with the use of fluoroscopyProcedure or surgery
ERCP removal of stone technique with the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with fluoroscopy images, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket, (5) confirmation of complete stone clearance with radiocontrast.
| Study group | Role | What they receive |
|---|---|---|
| ERCP without the use of fluoroscopy | Active comparator | Patients with uncomplicated bile duct stones detected by EUS was assigned to the EUS guided ERCP without fluoroscopy clear all of the bile duct stones. Receives: Procedure: ERCP without the use of fluoroscopy |
| ERCP with the use of fluoroscopy | Active comparator | Patients with uncomplicated bile duct stones detected by EUS was assigned to underwent ERCP with the use of fluoroscopy to clear all of the bile duct stones. Receives: Procedure: ERCP with the use of fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
The number of patients who achieved complete stone clearance in either EGWF or ERCP techniques.
Measured: 24 months
Secondary outcomes (1)
Technical success
The number of patient in whom bile duct was accessed with guide wire in either EGWF or ERCP techniques.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionOct 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 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
- Nisa Netinatsunton, MD., Principal investigator, NKC Institute of Gastroenterology and Hepatology , Faculty of Medicine, Prince of Songkla University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870686
- Sponsor's protocol ID
- EC: 56-199-21-3-2
- Status last verified
- Jun 2016
- First submitted
- 13 Aug 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient
Publications
Netinatsunton N, Sottisuporn J, Attasaranya S, Witeerungrot T, Siripun A, Pattarapuntakul T, Ovartlarnporn B. Prospective randomized trial of EUS-assisted ERCP without fluoroscopy versus ERCP in common bile duct stones. Gastrointest Endosc. 2017 Dec;86(6):1059-1065. doi: 10.1016/j.gie.2017.03.1539. Epub 2017 Apr 7.
PubMed 28392365
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing EUS Guided ERCP Without Fluoroscopy With Standard ERCP in Common Bile Duct Stone Removal
- ClinicalTrials.gov ID
- NCT02870686
- Acronym / sponsor ID
- EC: 56-199-21-3-2
- Conditions
- Choledocholithiasis
- Keywords
- ERCP, EUS guided ERCP without fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Aug 2016 (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.
For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is highy accurate technique in detecting common bile duct stone and guiding for therapeutic intervention. There has been a few data from literature showed that EUS guided CBD stone ( CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and complications. This randomized trial is designed to address the question that EUS guided CBDS removal is equivalent to ERCP in term of efficacy and safety.
Detailed description
Common bile duct stones (CBDS) can be complicated with various conditions including biliary pain, acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. CBDS should therefore be removed even if patients are asymptomatic.
Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone treatment of CBDS. ERCP is often performed under fluoroscopic guidance. This comprises biliary cannulation whereby the bile duct is achieved with a standard ERCP catheter under fluoroscopy guidance, radiocontrast was injected for confirmation and images of biliary system, location and number of CBDS, biliary sphincterotomy was then performed followed by stone extraction using a standard accessories such as a basket and or balloon. Therefore, the endoscopist, endoscopic staff and patient are potentially exposed to ionizing radiation during ERCP. Endoscopists should always attempt to minimize radiation exposure to the personnel staffs and patients by following the ALARA principle ("As Low As Reasonably Achievable"). ERCP without the use of fluoroscopy is the one method to avoid exposure to radiation. A few retrospective case series have been shown that ERCP can be performed with high success rate without the need for fluoroscopic imaging.
EUS has been proven to have diagnostic accuracy comparable to ERCP in the diagnosis of CBDS, and it's associated with a very low procedure related complications and non-radiation exposure procedure. With EUS performed before ERCP, unnecessary ERCP and its related complications can be avoided in patients without CBDS. In patients with CBDS, the images of pancreaticobiliary tract derived from EUS provide an information regarding the location, size and number of CBDS for guiding therapeutic endoscopy, and allowing a therapeutic ERCP in the same session of sedation. Vohra et al. reported the retrospective case series of EUS - based ERCP in 10 pregnant patients, they have shown that EUS performed prior ERCP can eliminate unnecessary ERCP and achieve in CBDS clearance without the use of fluoroscopy. We have previously reported the use of EUS guided ERCP in the removal of CBDS without fluoroscopy (EGWF) in the pilot study, it showed that EGWF was feasible in selected patients with CBDS. The efficacy of EUS guided ERCP in CBDS removal without fluoroscopy compared with standard ERCP has not been fully assessed. We therefore prospectively investigated the efficacy and safety of EGWF versus ERCP in CBDS removal in a larger patient cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP without the use of fluoroscopy | Active comparator | Procedure: ERCP without the use of fluoroscopyPatients with uncomplicated bile duct stones detected by EUS was assigned to the EUS guided ERCP without fluoroscopy clear all of the bile duct stones. |
| ERCP with the use of fluoroscopy | Active comparator | Procedure: ERCP with the use of fluoroscopyPatients with uncomplicated bile duct stones detected by EUS was assigned to underwent ERCP with the use of fluoroscopy to clear all of the bile duct stones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had EUS presence of CBDS ≤ 10 mm, and EUS images absence of CBD stricture and CBD narrowing below the stones
Key exclusion criteria (7 listed)
- pregnancy
- concomitant intrahepatic bile duct stones
- malignant bile duct stricture
- altered gastrointestinal anatomy
- instability hemodynamics
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 |
|---|---|---|
| ERCP without the use of fluoroscopyERCP removal of stone technique without the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with catheter aspiration of bile, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket- number of stones removed should compare number detected on EUS, (5) confirmation of complete stone clearance with radiocontrast. | Procedure or surgery | ERCP without the use of fluoroscopy |
| ERCP with the use of fluoroscopyERCP removal of stone technique with the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with fluoroscopy images, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket, (5) confirmation of complete stone clearance with radiocontrast. | Procedure or surgery | ERCP with the use of fluoroscopy |
Primary outcome
Treatment success
Time frame: 24 months
The number of patients who achieved complete stone clearance in either EGWF or ERCP techniques.
1 secondary outcome
Technical success
Time frame: 24 hours
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 14 Dec 2016.
- Derived from this study: PubMed 28392365Netinatsunton N, Sottisuporn J, Attasaranya S, Witeerungrot T, Siripun A, Pattarapuntakul T, Ovartlarnporn B. Prospective randomized trial of EUS-assisted ERCP without fluoroscopy versus ERCP in common bile duct stones. Gastrointest Endosc. 2017 Dec;86(6):1059-1065. doi: 10.1016/j.gie.2017.03.1539. Epub 2017 Apr 7.
- Individual participant dataSharing planned: No. The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient
Related trials for Choledocholithiasis
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
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.
Nisa Netinatsunton, MD. principal investigator
NKC Institute of Gastroenterology and Hepatology , Faculty of Medicine, Prince of Songkla University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP without the use of fluoroscopy and ERCP with the use of fluoroscopy in people with Choledocholithiasis, 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 1 inclusion and 7 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 14 Dec 2016. 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?
Treatment success (time frame: 24 months). 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 NCT02870686, 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 14 Dec 2016.