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

Changhai Hospital104 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Pancreatitis, Chronic Pancreatic Duct Stone

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Changhai Hospital

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: during ERCP procedure

Secondary Outcomes

timeout rate

Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 30 days after ERCP procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.