Common Bile Duct StonesNCT02958618
The Effect of Different Duration of Bolloon Dilation During ESBD
A study testing 30" group, 60" group and 180" group in people with Common Bile Duct Stones, run by RenJi Hospital at 1 site in China.
Trial summary
Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in treating common bile duct stones. It had the similar success rate of stone extraction, but its incidence of complications remained uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- 30" group, 60" group and 180" group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2018
- 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
- CBD stone patients, age≥18 years
- Stone diameter≤1.5cm
Who cannot join
- Unwilling to consent for the study
- Previous EST or EPBD
- Prior surgery of Bismuth Ⅱ and Roux-en-Y
- Benign or malignant CBD stricture
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Li Kewei, M.D., Ph.D., +8613003232119, keweipig@126.com
About this study
Official title: The Effect of Three Different Duration of Bolloon Dilation During ESBD in the Treatment of Common Bile Duct Stones
Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in treating common bile duct stones. It had the similar success rate of stone extraction, but its incidence of complications remained uncertain. However, there is no clinical evidence and guideline to define the optimal duration of balloon dilation so far. So we designed a prospective randomized trial to compare the effect of three different duration of balloon dilation during ESBD so that we can find the optimal duration of the balloon dilation.
Read the detailed description
Common Bile duct stones is one of the most common diseases of which the present incidence is 0.5% -3% in China. Endoscopic sphincterotomy (EST) is the most frequently used endoscopic technique for clearance of stones since the first description in 1974. Although EST is minimally invasive, it brings postoperative complications such as bleeding, perforation and acute pancreatitis. The overall complication and mortality is about 11.7-23% and 0.5%, respectively. Moreover, most believe EST can cause permanent sphincter of Oddi（SO） dysfunction which can result in biliary infection, stone recurrence and malignancies.
As an alternative method to EST, Endoscopic papillary balloon dilation (EPBD) was described by Staritz et al for the management of CBD stones. EPBD can preserve SO function and avoid undesirable effects due to an incompetent sphincter. It is reported that the basic SO function can be restored in one month after EPBD. Nonetheless, EPBD is indicated for the stones smaller than 12mm in diameters because the biliary orifice is enlarged to a lesser extent compared with EST. Furthermore, the incidence of postoperative pancreatitis reaches up to 15-30%. These disadvantages limit the application of EPBD.
As a result, Ersoz et al started a combined technique in 2003, which is called Endoscopic sphincterotomy with balloon dilation（ESBD）. ESBD can preserve SO function, reduce the adverse events, increase the stone removal rate. Especially, it can be applied for the stones larger than 12mm in diameters with large balloon dilatation. When ESBD is being performed, the duration of dilation is one of the most important factors affecting the postoperative complications. Whereas, there are issues regarding this technique that need further evaluation, such as the optimal duration of EPBD after EST. Some believe that short-term dilation can achieve the desired results and the duration of balloon dilation is not significantly correlated with postoperative pancreatitis, while opponents believe that although the small sphincterotomy is performed, short-term dilation has not been able to fully relax the residual sphincter. For long-term complications of ESBD, including the incidence of cholangitis, biliary stones recurrence rate, the incidence of biliary stenosis, there is no relative report either.
This prospective, randomized, controlled trial is designed to compare the difference of efficacy and morbidity among three different duration of balloon dilation（30s，60s，180s） after endoscopic sphincterotomy in the treatment of common bile duct stones. We hope that it will be helpful to establish the reasonable operation guidelines of ESBD.
- Conditions
- Common Bile Duct Stones
- Being tested
- 30" group, 60" group, 180" group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30" groupProcedure or surgery
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 30 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
60" groupProcedure or surgery
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 60 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
180" groupProcedure or surgery
A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18 ) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 180 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
| Study group | Role | What they receive |
|---|---|---|
| Duration for 30" group | Experimental | A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 30 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. Receives: Procedure: 30" group |
| Duration for 60" group | Experimental | A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 60 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. Receives: Procedure: 60" group |
| Duration for 180" group | Experimental | A limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 180 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. Receives: Procedure: 180" group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis
Patients with abdominal pain and serum amylase levels more than 3 times the upper limit of normal value. CT scanning is the best diagnostic discriminator
Measured: Within 7 days after ESBD
Secondary outcomes (8)
Bleeding
Haematemesis or malena is usually obvious immediately after sphincterotomy, but can be delayed for hours or even for several days.
Measured: Within 7 days after ESBD
Perforation
Contrast or air is seen radiologically in the peritoneal cavity or the retroperitoneal region which can be routinely confirmed on CT
Measured: Within 7 days after ESBD
Acute cholangitis
Patients typically present with fever, jaundice, and abdominal pain.
Measured: Within 7 days after ESBD
Pain
Upper abdominal pain measured by Visual Analogue ScaleScore.
Measured: Within 7 days after ERCP
Success rate for clearance of stones
The success of stone removal is verified by the cholangiography after ESBD
Measured: Within 72 hours after ERCP
Pancreatic duct insertion times
Times of the insertion of the duct or the guidewire into the pancreatic duct, no matter the depth
Measured: Within 24 hours after ESBD
Operation time
From the insertion of the endoscope to the end of nasobiliary tube fixation
Measured: Within 24 hours after ESBD
Hospital stay
from the admission to the discharge
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StonesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958618
- Sponsor's protocol ID
- PYZY16-011
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Duration of Bolloon Dilation During ESBD in the Treatment of Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT02958618
- Acronym / sponsor ID
- PYZY16-011
- Conditions
- Common Bile Duct Stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Nov 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.
Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in treating common bile duct stones. It had the similar success rate of stone extraction, but its incidence of complications remained uncertain. However, there is no clinical evidence and guideline to define the optimal duration of balloon dilation so far. So we designed a prospective randomized trial to compare the effect of three different duration of balloon dilation during ESBD so that we can find the optimal duration of the balloon dilation.
Detailed description
Common Bile duct stones is one of the most common diseases of which the present incidence is 0.5% -3% in China. Endoscopic sphincterotomy (EST) is the most frequently used endoscopic technique for clearance of stones since the first description in 1974. Although EST is minimally invasive, it brings postoperative complications such as bleeding, perforation and acute pancreatitis. The overall complication and mortality is about 11.7-23% and 0.5%, respectively. Moreover, most believe EST can cause permanent sphincter of Oddi（SO） dysfunction which can result in biliary infection, stone recurrence and malignancies.
As an alternative method to EST, Endoscopic papillary balloon dilation (EPBD) was described by Staritz et al for the management of CBD stones. EPBD can preserve SO function and avoid undesirable effects due to an incompetent sphincter. It is reported that the basic SO function can be restored in one month after EPBD. Nonetheless, EPBD is indicated for the stones smaller than 12mm in diameters because the biliary orifice is enlarged to a lesser extent compared with EST. Furthermore, the incidence of postoperative pancreatitis reaches up to 15-30%. These disadvantages limit the application of EPBD.
As a result, Ersoz et al started a combined technique in 2003, which is called Endoscopic sphincterotomy with balloon dilation（ESBD）. ESBD can preserve SO function, reduce the adverse events, increase the stone removal rate. Especially, it can be applied for the stones larger than 12mm in diameters with large balloon dilatation. When ESBD is being performed, the duration of dilation is one of the most important factors affecting the postoperative complications. Whereas, there are issues regarding this technique that need further evaluation, such as the optimal duration of EPBD after EST. Some believe that short-term dilation can achieve the desired results and the duration of balloon dilation is not significantly correlated with postoperative pancreatitis, while opponents believe that although the small sphincterotomy is performed, short-term dilation has not been able to fully relax the residual sphincter. For long-term complications of ESBD, including the incidence of cholangitis, biliary stones recurrence rate, the incidence of biliary stenosis, there is no relative report either.
This prospective, randomized, controlled trial is designed to compare the difference of efficacy and morbidity among three different duration of balloon dilation（30s，60s，180s） after endoscopic sphincterotomy in the treatment of common bile duct stones. We hope that it will be helpful to establish the reasonable operation guidelines of ESBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duration for 30" group | Experimental | Procedure: 30" groupA limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 30 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. |
| Duration for 60" group | Experimental | Procedure: 60" groupA limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 60 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. |
| Duration for 180" group | Experimental | Procedure: 180" groupA limited sphincterotomy measuring up to one-third of the size of the papilla was first performed. Dilation with a controlled radial expansion (CRE) balloon (diameter 10, 12, 15, 18 ) was performed after the sphincterotomy. The balloon was centered at the sphincter and gradually filled with diluted contrast under endoscopic and fluoroscopic guidance until waisting was abolished. Once the waist had disappeared, the balloon was kept in position for 180 seconds. The stones were then removed by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CBD stone patients, age≥18 years
- Stone diameter≤1.5cm
Key exclusion criteria (6 listed)
- Unwilling to consent for the study
- Previous EST or EPBD
- Prior surgery of Bismuth Ⅱ and Roux-en-Y
- Benign or malignant CBD stricture
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
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 |
|---|---|---|
| 30" groupA limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 30 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. | Procedure or surgery | Duration for 30" group |
| 60" groupA limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 60 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. | Procedure or surgery | Duration for 60" group |
| 180" groupA limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18 ) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 180 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal. | Procedure or surgery | Duration for 180" group |
Primary outcome
Post-ERCP pancreatitis
Time frame: Within 7 days after ESBD
Patients with abdominal pain and serum amylase levels more than 3 times the upper limit of normal value. CT scanning is the best diagnostic discriminator
8 secondary outcomes
Bleeding
Time frame: Within 7 days after ESBD
Perforation
Time frame: Within 7 days after ESBD
Acute cholangitis
Time frame: Within 7 days after ESBD
Pain
Time frame: Within 7 days after ERCP
Success rate for clearance of stones
Time frame: Within 72 hours after ERCP
Pancreatic duct insertion times
Time frame: Within 24 hours after ESBD
Operation time
Time frame: Within 24 hours after ESBD
Hospital stay
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30" group, 60" group and 180" group in people with Common Bile Duct Stones, run by RenJi Hospital at 1 site in China.
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 6 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 8 Nov 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 China. 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 Li Kewei, M.D., Ph.D. (+8613003232119, keweipig@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ERCP pancreatitis (time frame: Within 7 days after ESBD). 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 8 Nov 2016.