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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changhai Hospital
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- clearance rates of pancreatic duct stones
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treating pancreatic duct stones by using baskets
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.
Intervention: Basket group (Device)
Treating pancreatic duct stones by using balloons
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.
Intervention: Balloon group (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- time taken to completely clear the stone(during ERCP procedure)
- timeout rate(during ERCP procedure)
- number of times to completely clear the stone(during ERCP procedure)
- post-ERCP complications(30 days after ERCP procedure)
Investigators
Zhaoshen Li
Professor
Changhai Hospital