Biliary CalculiPhase 4NCT02909595
Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction
A Phase 4 study testing Balloon catheter and Basket catheter in people with Biliary Calculi, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Calculi
- What is being tested?
- Balloon catheter and Basket catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 4
- 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
- Males and females, age > 18 years.
- BDSs of diameter ≤10mm, which could be extracted using a standard balloon or basket catheter without mechanical lithotripsy, and a common bile duct (CBD) diameter ≤15mm.
- Signed inform consent form and agreed to follow-up on time
Who cannot join
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- Patients involved in other study within 60 days.
- biliary stricture
- Billroth II or Roux-en-Y anatomy
- Acute pancreatitis.
- a history of previous ERCP
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Hefei, Anhui, 230001
About this study
Official title: Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial
Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.
Read the detailed description
A prospective, multi-center, investigator sponsored, randomized controlled trial, 80 subjects will be randomly assigned to groups that were treated with basket or balloon catheters.
A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
- Conditions
- Biliary Calculi
- Being tested
- Balloon catheter, Basket catheter
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon catheterDevice
Balloon stone extraction was carried out with a balloon catheter [Extractor Pro RX [M00547000, M00547010, or M00547020]; Boston Scientific,Shang hai,China). The Extractor Pro has multiple sizes (9-12, 12-15, and 15-18mm), the choice being made on the basis of the CBD diameter. It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC).
Basket catheterDevice
Basket stone extraction was performed with a basket catheter (Flower Basket V [FG-V435P or FG-V425PR]; Olympus Corp., Shang hai,China).
| Study group | Role | What they receive |
|---|---|---|
| Balloon catheter group | Experimental | Bile duct stones extraction was carried out with a balloon catheter. Receives: Device: Balloon catheter |
| Basket catheter group | Active comparator | Bile duct stones extraction was carried out with a basket catheter. Receives: Device: Basket catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the rate of complete clearance of the duct in two groups.
It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC). For balloon stone extraction, clearance was confirmed if no residual stones remained after the final BOC and balloon sweep. For basket stone extraction, duct clearance by the basket catheter was judged to have been completed when no filling defect was found. Complete clearance of the duct by the basket catheter was defined as no filling defect (other than air) on BOC after a balloon sweep.
Measured: The primary end point was the rate of complete removals of stones within 10 min.
Secondary outcomes (1)
Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.
Measured: Secondary endpoints is the rate of adverse events at 24 h after ERCP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CalculiStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shao Feng, MD, Principal investigator, Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical UniversityWei Qi, MD, Principal investigator, No.2 of HeFei Hospital Affiliated Anhui Medical CollegeYongQiang Jiang, MD, Principal investigator, Dong fang Hospital Affiliated Anhui University Of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909595
- Sponsor's protocol ID
- Catheter001
- Status last verified
- Sep 2016
- First submitted
- 10 Sep 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT02909595
- Acronym / sponsor ID
- Catheter001
- Conditions
- Biliary Calculi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Sep 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.
Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.
Detailed description
A prospective, multi-center, investigator sponsored, randomized controlled trial, 80 subjects will be randomly assigned to groups that were treated with basket or balloon catheters.
A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon catheter group | Experimental | Device: Balloon catheterBile duct stones extraction was carried out with a balloon catheter. |
| Basket catheter group | Active comparator | Device: Basket catheterBile duct stones extraction was carried out with a basket catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, age > 18 years.
- BDSs of diameter ≤10mm, which could be extracted using a standard balloon or basket catheter without mechanical lithotripsy, and a common bile duct (CBD) diameter ≤15mm.
- Signed inform consent form and agreed to follow-up on time
Key exclusion criteria (7 listed)
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- Patients involved in other study within 60 days.
- biliary stricture
- Billroth II or Roux-en-Y anatomy
- Acute pancreatitis.
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 |
|---|---|---|
| Balloon catheterBalloon stone extraction was carried out with a balloon catheter [Extractor Pro RX [M00547000, M00547010, or M00547020]; Boston Scientific,Shang hai,China). The Extractor Pro has multiple sizes (9-12, 12-15, and 15-18mm), the choice being made on the basis of the CBD diameter. It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC). | Device | Balloon catheter group |
| Basket catheterBasket stone extraction was performed with a basket catheter (Flower Basket V [FG-V435P or FG-V425PR]; Olympus Corp., Shang hai,China). | Device | Basket catheter group |
Primary outcome
The primary endpoint is the rate of complete clearance of the duct in two groups.
Time frame: The primary end point was the rate of complete removals of stones within 10 min.
It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC). For balloon stone extraction, clearance was confirmed if no residual stones remained after the final BOC and balloon sweep. For basket stone extraction, duct clearance by the basket catheter was judged to have been completed when no filling defect was found. Complete clearance of the duct by the basket catheter was defined as no filling defect (other than air) on BOC after a balloon sweep.
1 secondary outcome
Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
Time frame: Secondary endpoints is the rate of adverse events at 24 h after ERCP.
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.
- Individual participant dataSharing planned: No
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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.
Shao Feng, MD principal investigator
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Wei Qi, MD principal investigator
No.2 of HeFei Hospital Affiliated Anhui Medical College
YongQiang Jiang, MD principal investigator
Dong fang Hospital Affiliated Anhui University Of Science & Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balloon catheter and Basket catheter in people with Biliary Calculi, run by Anhui Provincial 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 3 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is the rate of complete clearance of the duct in two groups. (time frame: The primary end point was the rate of complete removals of stones within 10 min.). 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 14 Dec 2016.