CholedocholithiasisNCT05035433
Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP
A study testing First lithotripsy and then EPBD and First EPBD and then lithotripsy in people with Choledocholithiasis and Cholangiopancreatography, Endoscopic Retrograde, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3% ~ 31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- First lithotripsy and then EPBD and First EPBD and then lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2020to Jan 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated >5 or<5)
- During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP
- Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
- Subjects voluntarily participate in this study and sign the informed consent
Who cannot join
- Coagulation disorders (INR>1.3) and peripheral blood plate count significantly decreased<50x10^9/L
- Preoperative complicated with acute pancreatitis
- Preoperative biliary hemorrhage
- Complicated with severe liver disease and primary sclerosing cholangitis
- Mirizzi syndrome and intrahepatic bile duct stones
- Complicated malignant tumor of hepatobiliary and pancreatic system
Show all 10Show fewer
- Complicated with obvious stricture of the lower segment of the bile duct
- intraoperative bile duct duodenal fistula was found
- Previous EST or EPBD
- Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Weng Hao, PhD, 15000564124, wenghao@xinhuamed.com.cn
About this study
Official title: A Prospective, Multicenter Clinical Study of the Effect of the Order of Dilatation of Papillary Muscle and Mechanical Lithotripsy on the Efficacy and Postoperative Complications of ERCP in the Treatment of Choledocholithiasis.
Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3% ~ 31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.Therefore, we used the method of balloon dilation combined with mechanical lithotripsy after EST.There are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard.
Through the ERCP balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ERCP in the treatment of huge stones optimization procedure was formulated.
- Being tested
- First lithotripsy and then EPBD, First EPBD and then lithotripsy
- Keywords
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy, Endoscopic papillary balloon dilation
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First lithotripsy and then EPBDProcedure or surgery
After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation.
First EPBD and then lithotripsyProcedure or surgery
After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation.
| Study group | Role | What they receive |
|---|---|---|
| First lithotripsy and then EPBD | Experimental | After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation. Receives: Procedure: First lithotripsy and then EPBD |
| First EPBD and then lithotripsy | Experimental | After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation. Receives: Procedure: First EPBD and then lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lithotomy time
The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation
Measured: About 20 minutes
Stone residual rate
Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones
Measured: about 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start6 Sep 2020
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Pudong Hospital
- Responsible party
- Principal investigator, Xuefeng Wang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wang Xuefeng, PhD, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035433
- Sponsor's protocol ID
- XH-20-022
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of the Effect of the Order of Dilatation of Papillary Muscle and Mechanical Lithotripsy on the Efficacy and Postoperative Complications of ERCP in the Treatment of Choledocholithiasis.
- ClinicalTrials.gov ID
- NCT05035433
- Acronym / sponsor ID
- XH-20-022
- Keywords
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Lithotripsy, Endoscopic papillary balloon dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Pudong Hospital
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Sep 2021 (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.
Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3% ~ 31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.Therefore, we used the method of balloon dilation combined with mechanical lithotripsy after EST.There are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard.
Through the ERCP balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ERCP in the treatment of huge stones optimization procedure was formulated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First lithotripsy and then EPBD | Experimental | Procedure: First lithotripsy and then EPBDAfter successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation. |
| First EPBD and then lithotripsy | Experimental | Procedure: First EPBD and then lithotripsyAfter puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated >5 or<5)
- During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP
- Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
- Subjects voluntarily participate in this study and sign the informed consent
Key exclusion criteria (10 listed)
- Coagulation disorders (INR>1.3) and peripheral blood plate count significantly decreased<50x10^9/L
- Preoperative complicated with acute pancreatitis
- Preoperative biliary hemorrhage
- Complicated with severe liver disease and primary sclerosing cholangitis
- Mirizzi syndrome and intrahepatic bile duct stones
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 |
|---|---|---|
| First lithotripsy and then EPBDAfter successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation. | Procedure or surgery | First lithotripsy and then EPBD |
| First EPBD and then lithotripsyAfter puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation. | Procedure or surgery | First EPBD and then lithotripsy |
Primary outcome
Lithotomy time
Time frame: About 20 minutes
The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation
Stone residual rate
Time frame: about 2 days
Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Wang Xuefeng, PhD study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First lithotripsy and then EPBD and First EPBD and then lithotripsy in people with Choledocholithiasis and Cholangiopancreatography, Endoscopic Retrograde, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 10 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 5 Sep 2021. 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 Wang Xuefeng, PhD (13601833209, wangxuefeng@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lithotomy time (time frame: About 20 minutes). The study lists 2 primary outcomes in all. 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 5 Sep 2021.