Chronic PancreatitisNCT05888012
Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- basket catheter and balloon catheter
- Type of treatment
- Medical device
- How many people
- 6,493 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 10 Apr 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CP patients with pancreatic duct stones who underwent ERCP between February 2012 and December 2021were identified. The diagnosis of CP was established based on computed tomography, magnetic resonance imaging or endoscopic ultrasound examinations.
Who may be able to join
- CP patients with main pancreatic duct (MPD) stones who underwent ERCP
Who cannot join
- Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
- Patients were suspected of having a malignant tumor
- Patients combined with bile duct stones
- Patients had severe pancreatic duct structure
- Patients with insufficient clinical data
- Patients with previous ERCP treatment
- Patients had received both catheters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Comparison of Balloon Catheter and Basket Catheter for Endoscopic Pancreatic Duct Stone Clearance
The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.
Read the detailed description
This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.
- Conditions
- Chronic Pancreatitis
- Being tested
- basket catheter, balloon catheter
- Keywords
- Pancreatic stone, Endoscopic retrograde cholangiopancreatography (ERCP), Basket catheter, Balloon catheter, Stone clearance
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basket catheterDevice
Stone extraction is completed with either a basket or balloon catheter at the time of ERCP. The basket catheter is made of nickel-titanium wires which can be manipulated to trap and withdraw stones.
balloon catheterDevice
Stone extraction is completed with either a basket or balloon catheter at the time of ERCP. The balloon catheter is made of latex, which is inflated after passing the stone, thus pushing the stone outwards.
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of stone clearance in basket and balloon catheter groups
complete clearance, defined as fragmentation of the pancreatic stones to < 3 mm and clearance of more than 90% of the fragments; partial clearance, defined as clearance of 50-90% of the fragments; and unsuccessful clearance, defined as the presence of pancreatic stones ≥ 3 mm or clearance of less than 50% of the fragments.
Measured: 1 year after ERCP
Secondary outcomes (1)
the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups
ERCP peri-procedural outcomes included difficult cannulation, endoscopic sphincterotomy, dilation of stenosis, and extraction through the minor papilla. Major post-ERCP complications, which were defined according to the Consensus Criteria, included post-ERCP pancreatitis (PEP), bleeding, infection, perforation, and basket impaction
Measured: 1 year after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Feb 2012
- Primary completion31 Dec 2021
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888012
- Sponsor's protocol ID
- Basket vs. Balloon
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Balloon Catheter and Basket Catheter for Endoscopic Pancreatic Duct Stone Clearance
- ClinicalTrials.gov ID
- NCT05888012
- Acronym / sponsor ID
- Basket vs. Balloon
- Conditions
- Chronic Pancreatitis
- Keywords
- Pancreatic stone, Endoscopic retrograde cholangiopancreatography (ERCP), Basket catheter, Balloon catheter, Stone clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,493 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 5 Jun 2023 (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.
The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.
Detailed description
This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CP patients with pancreatic duct stones who underwent ERCP between February 2012 and December 2021were identified. The diagnosis of CP was established based on computed tomography, magnetic resonance imaging or endoscopic ultrasound examinations.
Key inclusion criteria (1 listed)
- CP patients with main pancreatic duct (MPD) stones who underwent ERCP
Key exclusion criteria (7 listed)
- Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
- Patients were suspected of having a malignant tumor
- Patients combined with bile duct stones
- Patients had severe pancreatic duct structure
- Patients with insufficient clinical data
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 |
|---|---|---|
| basket catheterStone extraction is completed with either a basket or balloon catheter at the time of ERCP. The basket catheter is made of nickel-titanium wires which can be manipulated to trap and withdraw stones. | Device | – |
| balloon catheterStone extraction is completed with either a basket or balloon catheter at the time of ERCP. The balloon catheter is made of latex, which is inflated after passing the stone, thus pushing the stone outwards. | Device | – |
Primary outcome
the rate of stone clearance in basket and balloon catheter groups
Time frame: 1 year after ERCP
complete clearance, defined as fragmentation of the pancreatic stones to < 3 mm and clearance of more than 90% of the fragments; partial clearance, defined as clearance of 50-90% of the fragments; and unsuccessful clearance, defined as the presence of pancreatic stones ≥ 3 mm or clearance of less than 50% of the fragments.
1 secondary outcome
the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups
Time frame: 1 year 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 5 Jun 2023.
- 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.
Zhuan Liao principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Changhai 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 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 5 Jun 2023. 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?
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 rate of stone clearance in basket and balloon catheter groups (time frame: 1 year 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 5 Jun 2023.