Pancreatitis, ChronicNCT05289362
Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP
A study testing Basket group and Balloon group in people with Pancreatitis, Chronic and Pancreatic Duct Stone, run by Changhai Hospital at 1 site in China.
Trial summary
This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Chronic, Pancreatic Duct Stone
- What is being tested?
- Basket group and Balloon group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 12 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
- stones (≤5 mm in diameter) are located in the main pancreatic duct of the pancreatic head/body with dilation of the proximal pancreatic duct.
Who cannot join
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
- acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
- there is a stent in the main pancreatic duct;
- coagulation dysfunction (INR≥1.5 or platelet count≤50×10^9/L);
- pregnant or breastfeeding women;
- patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP: a Single-blind, Parallel, Randomized Controlled Clinical Study
This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.
Read the detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the pancreas by using basket and/or balloon catheter.
In the clinical work of investigators' center, the ERCP treatment of pancreatic duct stones also mainly adopts basket and balloon, but whether to try basket or balloon first is mainly determined by the subjective decision of the on-site endoscopist. More than 70% of patients use the above two tools in one ERCP operation, which aims to achieve better effect, but the order of the two tools is uncertain.
However, there is no relevant research on whether the first choice for the treatment of pancreatic duct stones is the basket or the balloon, or the combination of the two tools. This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP, including the difference of stone clearance rate, abdominal pain score (Izbicki Pain Score), postoperative complications and medical expenses.
- Conditions
- Pancreatitis, Chronic, Pancreatic Duct Stone
- Being tested
- Basket group, Balloon group
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
- 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 groupDevice
Under ERCP, the basket is preferentially used to remove the pancreatic duct stones, and then the balloon is used to evaluate the effect and remove the residual stones.
Balloon groupDevice
Under ERCP, the balloon is preferentially used to remove the pancreatic duct stones, and then the basket is used to evaluate the effect and remove the residual stones.
| Study group | Role | What they receive |
|---|---|---|
| Treating pancreatic duct stones by using baskets | Experimental | ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the basket will be used to remove the stones first, and the balloon will replace the basket after 15 minutes to remove any remaining stones. Finally, the effect of the basket will be evaluated. Receives: Device: Basket group |
| Treating pancreatic duct stones by using balloons | Active comparator | ERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the balloon will be used to remove the stones first, and the basket will replace the balloon after 15 minutes to remove any remaining stones. Finally, the effect of the balloon will be evaluated. Receives: Device: Balloon group |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance rates of pancreatic duct stones
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively.
Measured: during ERCP procedure
Secondary outcomes (4)
timeout rate
Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes.
Measured: during ERCP procedure
time taken to completely clear the stone
The time taken by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
Measured: during ERCP procedure
number of times to completely clear the stone
The number of attempts made by the basket or balloon to completely clear the stones in the targeted area of the pancreatic duct.
Measured: during ERCP procedure
post-ERCP complications
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.
Measured: 30 days after ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Jun 2022
- Primary completion10 Feb 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289362
- Sponsor's protocol ID
- XH202202
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
PubMed 31238312Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, Sun T, Liu M, Zou W, Ye B, Liu F, Wang D, Cao N, Liao Z, Li Z. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918. doi: 10.1038/srep04918.
PubMed 24819780
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP: a Single-blind, Parallel, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05289362
- Acronym / sponsor ID
- XH202202
- Conditions
- Pancreatitis, Chronic, Pancreatic Duct Stone
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 21 Mar 2022 (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.
This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.
Detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the pancreas by using basket and/or balloon catheter.
In the clinical work of investigators' center, the ERCP treatment of pancreatic duct stones also mainly adopts basket and balloon, but whether to try basket or balloon first is mainly determined by the subjective decision of the on-site endoscopist. More than 70% of patients use the above two tools in one ERCP operation, which aims to achieve better effect, but the order of the two tools is uncertain.
However, there is no relevant research on whether the first choice for the treatment of pancreatic duct stones is the basket or the balloon, or the combination of the two tools. This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP, including the difference of stone clearance rate, abdominal pain score (Izbicki Pain Score), postoperative complications and medical expenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treating pancreatic duct stones by using baskets | Experimental | Device: Basket groupERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the basket will be used to remove the stones first, and the balloon will replace the basket after 15 minutes to remove any remaining stones. Finally, the effect of the basket will be evaluated. |
| Treating pancreatic duct stones by using balloons | Active comparator | Device: Balloon groupERCP will be performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, Endoscopic Sphincterotomy or Endoscopic Papillary Balloon Dilatation will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, the balloon will be used to remove the stones first, and the basket will replace the balloon after 15 minutes to remove any remaining stones. Finally, the effect of the balloon will be evaluated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
- stones (≤5 mm in diameter) are located in the main pancreatic duct of the pancreatic head/body with dilation of the proximal pancreatic duct.
Key exclusion criteria (8 listed)
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
- acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
- there is a stent in the main pancreatic duct;
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 groupUnder ERCP, the basket is preferentially used to remove the pancreatic duct stones, and then the balloon is used to evaluate the effect and remove the residual stones. | Device | Treating pancreatic duct stones by using baskets |
| Balloon groupUnder ERCP, the balloon is preferentially used to remove the pancreatic duct stones, and then the basket is used to evaluate the effect and remove the residual stones. | Device | Treating pancreatic duct stones by using balloons |
Primary outcome
clearance rates of pancreatic duct stones
Time frame: during ERCP procedure
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively.
4 secondary outcomes
timeout rate
Time frame: during ERCP procedure
time taken to completely clear the stone
Time frame: during ERCP procedure
number of times to completely clear the stone
Time frame: during ERCP procedure
post-ERCP complications
Time frame: 30 days after ERCP procedure
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 12 Jun 2026.
- Background: PubMed 31238312Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
- Background: PubMed 24819780Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, Sun T, Liu M, Zou W, Ye B, Liu F, Wang D, Cao N, Liao Z, Li Z. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918. doi: 10.1038/srep04918.
- 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.
Liang-hao Hu, MD 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?
A study testing Basket group and Balloon group in people with Pancreatitis, Chronic and Pancreatic Duct Stone, 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 2 inclusion and 8 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 12 Jun 2026. 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?
clearance rates of pancreatic duct stones (time frame: during ERCP procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289362, which also lists 2 linked publications.
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 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.