Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP

Study Overview
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Brief Summary
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This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.

Detailed Description
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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.

Official Title
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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

Conditions
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Pancreatitis, Chronic, Pancreatic Duct Stone

Intervention / Treatment
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* Device: Basket group
* Device: Balloon group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treating pancreatic duct stones by using baskets<br>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. | Device: Basket group<br>* 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.<br>|
| Active Comparator: Treating pancreatic duct stones by using balloons<br>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. | Device: Balloon group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during ERCP procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timeout rate | Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes. | 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. | 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. | 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. | 30 days after ERCP procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiopancreatography, Endoscopic Retrograde