Cholangiopancreatography, Endoscopic RetrogradeNCT03683485
Long-duration EPBD vs EST for Removal of Biliary Stones
A study testing long duration EPBD and EST in people with Cholangiopancreatography, Endoscopic Retrograde, run by Dankook University at 4 sites in South Korea.
Trial summary
Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- long duration EPBD and EST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Apr 2018to 1 Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients were invited to participate by the investigators or research staff if they were at least 18 years old,
- patients who had known or suspected choledocholithiasis
Who cannot join
- active acute pancreatitis
- septic shock,
- coagulopathy (international normalized ratio >1.2, partial thromboplastic time greater than twice that of control),
- platelet count <50,000 x 103/uL,
- anticoagulation therapy within 48 hours of the procedure,
- stone diameter > 8 mm,
Show all 13Show fewer
- bile duct diameter >15 mm, prior sphincterotomy,
- need for precut sphincterotomy for biliary access,
- biliary stricture,
- Billroth II or Roux-en-Y anatomy,
- periampullary malignancies,
- primary sclerosing cholangitis, pregnancy,
- and inability to give informed consent
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Inje University, Haeundae Paik Hospital
Busan
Joon Hyuck Choi, MD, cladius2@naver.com
- Recruiting
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, 330-715
Jun Ho Choi, MD, PhD, 82-41-550-7631, mdcjh78@gmail.com
Se Weon Kim, MD, 82-41-550-6694, intern41@dkuh.co.kr
- Recruiting
St. Mary's Hospital, The Catholic University of Korea,
Daejeon
Won Seok Park, MD, mdonekr@naver.com
Kyu-Hyun Paik, MD
- Recruiting
Wonkwang University
Iksan, Jeollabukdo
Hyung Ku Chon, MD, 82-63-859-2564, menzo@jbnu.ac.kr
Tae Hyeon Kim, MD, PhD, kth@wonkwang.ac.kr
About this study
Official title: Long-duration (3 Minutes) Endoscopic Papillary Balloon Dilation Versus Endoscopic Sphincterotomy in Patients With a Naive Major Papilla and Small- to Medium Sized Biliary Stones: Multicenter, Randomized, Controlled Trial
Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. However, recent meta-analyses indicate that short EPBD duration increases the risk of post-ERCP pancreatitis, and EPBD with adequate duration has a similar pancreatitis risk and a lower overall complication rate compared with EST for choledocholithiasis.
Therefore, this study aim to compare long-duration EPBD vs EST in the treatment of extrahepatic biliary stones.
Read the detailed description
Gallstones occur in 10%-15% of adults in the United States and are the most common and costly digestive disorder. Concomitant bile duct stones occur in up to 15% of persons with symptomatic gallstones. Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy is the standard treatment for removal choledocholithiasis. The biliary sphincter is permanently ablated by sphincterotomy. Enteric-biliary reflux occurs with bacterial colonization, increased bile lithogenicity, contamination with cytotoxins, and chronic inflammation of the biliary system. Endoscopic papillary balloon dilation (EPBD) has become an option for removal of stones 1 cm or smaller in size. Advantages of EPBD over EST include a decreased risk of post-ERCP bleeding as well as a decreased risk of stone recurrence and cholangitis. Although a short dilation duration (≤1 minute) was previously advocated, a study that performed EPBD for 1 minute observed a 15.4% risk of post-ERCP pancreatitis with 2 cases of mortality. European Society of Gastrointestinal Endoscopy guideline recommends that the duration of EPBD should exceed 2 minutes because long-duration EPBD (>1 minute) is preferred over short-duration EPBD (≤1 minute) with better outcomes. A meta-analysis of RCTs showed that the duration of EPBD is inversely associated with the risk of PEP. Previous RCTs comparing outcome between EPBD and EST used short EPBD duration between 25 seconds and 1 minute, and there has been no comparison of outcome between EST and long-duration EPBD. The aim of this study was to compare the early and long term outcomes of patients treated with long duration balloon dilation or sphincterotomy for extraction of bile duct stones in a randomized, multicenter fashion involving a broad spectrum of practices.
- Being tested
- long duration EPBD, EST
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long duration EPBDProcedure or surgery
An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy.
ESTProcedure or surgery
After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold.
| Study group | Role | What they receive |
|---|---|---|
| long duration EPBD group | Experimental | Balloon dilation was performed using wire-guided hydrostatic balloon catheters. An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy. Stones were removed by standard techniques, including balloon or basket catheters. Receives: Procedure: long duration EPBD; Procedure: EST |
| endoscopic sphincterotomy (EST) group | Active comparator | After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. Receives: Procedure: long duration EPBD; Procedure: EST |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of adverse event
Number of participants with treatment-related adverse events
Measured: up to 1 month after ERCP
Secondary outcomes (6)
the stone clearance rate at the index ERCP
complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure
Measured: during ERCP
direct cost
The direct cost included the total cost for the entire admission, which comprised costs of hospital stay, performed procedures, and management of complications
Measured: within 30 day after ERCP
recurrence of choledocholithiasis
recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications
Measured: more than 3 year follow-up
adverse event (pancreatitis)
rate of pancreatitis
Measured: up to 1 month after ERCP
adverse event (bleeding)
rate of bleeding
Measured: up to 1 month after ERCP
adverse event (cholangitis)
rate of cholangitis
Measured: up to 1 month after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Apr 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dankook University
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, The Catholic University of Korea, Wonkwang University
- Responsible party
- Principal investigator, Jun Ho Choi, Dankook University
- Investigators
- Jun Ho Choi, MD, PhD, Principal investigator, Dankook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683485
- Sponsor's protocol ID
- 2018-03-009
- Status last verified
- Sep 2018
- First submitted
- 5 Apr 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-duration (3 Minutes) Endoscopic Papillary Balloon Dilation Versus Endoscopic Sphincterotomy in Patients With a Naive Major Papilla and Small- to Medium Sized Biliary Stones: Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03683485
- Acronym / sponsor ID
- 2018-03-009
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Dankook UniversityUniversity, hospital or other
- Collaborators
- Inje University, The Catholic University of Korea, Wonkwang University
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 25 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.
Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. However, recent meta-analyses indicate that short EPBD duration increases the risk of post-ERCP pancreatitis, and EPBD with adequate duration has a similar pancreatitis risk and a lower overall complication rate compared with EST for choledocholithiasis.
Therefore, this study aim to compare long-duration EPBD vs EST in the treatment of extrahepatic biliary stones.
Detailed description
Gallstones occur in 10%-15% of adults in the United States and are the most common and costly digestive disorder. Concomitant bile duct stones occur in up to 15% of persons with symptomatic gallstones. Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy is the standard treatment for removal choledocholithiasis. The biliary sphincter is permanently ablated by sphincterotomy. Enteric-biliary reflux occurs with bacterial colonization, increased bile lithogenicity, contamination with cytotoxins, and chronic inflammation of the biliary system. Endoscopic papillary balloon dilation (EPBD) has become an option for removal of stones 1 cm or smaller in size. Advantages of EPBD over EST include a decreased risk of post-ERCP bleeding as well as a decreased risk of stone recurrence and cholangitis. Although a short dilation duration (≤1 minute) was previously advocated, a study that performed EPBD for 1 minute observed a 15.4% risk of post-ERCP pancreatitis with 2 cases of mortality. European Society of Gastrointestinal Endoscopy guideline recommends that the duration of EPBD should exceed 2 minutes because long-duration EPBD (>1 minute) is preferred over short-duration EPBD (≤1 minute) with better outcomes. A meta-analysis of RCTs showed that the duration of EPBD is inversely associated with the risk of PEP. Previous RCTs comparing outcome between EPBD and EST used short EPBD duration between 25 seconds and 1 minute, and there has been no comparison of outcome between EST and long-duration EPBD. The aim of this study was to compare the early and long term outcomes of patients treated with long duration balloon dilation or sphincterotomy for extraction of bile duct stones in a randomized, multicenter fashion involving a broad spectrum of practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long duration EPBD group | Experimental | Procedure: long duration EPBD, Procedure: ESTBalloon dilation was performed using wire-guided hydrostatic balloon catheters. An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy. Stones were removed by standard techniques, including balloon or basket catheters. |
| endoscopic sphincterotomy (EST) group | Active comparator | Procedure: long duration EPBD, Procedure: ESTAfter deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients were invited to participate by the investigators or research staff if they were at least 18 years old,
- patients who had known or suspected choledocholithiasis
Key exclusion criteria (13 listed)
- active acute pancreatitis
- septic shock,
- coagulopathy (international normalized ratio >1.2, partial thromboplastic time greater than twice that of control),
- platelet count <50,000 x 103/uL,
- anticoagulation therapy within 48 hours of the procedure,
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 |
|---|---|---|
| long duration EPBDAn 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy. | Procedure or surgery | endoscopic sphincterotomy (EST) group, long duration EPBD group |
| ESTAfter deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold. | Procedure or surgery | endoscopic sphincterotomy (EST) group, long duration EPBD group |
Primary outcome
rate of adverse event
Time frame: up to 1 month after ERCP
Number of participants with treatment-related adverse events
6 secondary outcomes
the stone clearance rate at the index ERCP
Time frame: during ERCP
direct cost
Time frame: within 30 day after ERCP
recurrence of choledocholithiasis
Time frame: more than 3 year follow-up
adverse event (pancreatitis)
Time frame: up to 1 month after ERCP
adverse event (bleeding)
Time frame: up to 1 month after ERCP
adverse event (cholangitis)
Time frame: up to 1 month after ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
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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.
Jun Ho Choi, MD, PhD principal investigator
Dankook University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long duration EPBD and EST in people with Cholangiopancreatography, Endoscopic Retrograde, run by Dankook University at 4 sites in South Korea.
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 13 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
Contact Jun Ho Choi, MD, PhD (82-41-550-7631, mdcjh78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of adverse event (time frame: up to 1 month after ERCP). 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 1 Oct 2018.