Changhai Hospital
Shanghai, 200433, China
NCT Number: NCT05289362
This study will compare the efficacy of basket and balloon in the removal of pancreatic duct stones under ERCP.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Shanghai, 200433, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: during ERCP procedure
Basket or balloon cannot completely remove stones in the targeted area of the pancreatic duct within 15 minutes.
Time frame: during ERCP procedure
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
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: 30 days after ERCP procedure
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
Postoperative and preoperative abdominal pain was assessed using the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (no pain) to 100 (severe pain).
Changhai Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05772234
Chronic Disease, Digestive System Diseases
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05270434
Chronic Disease, Digestive System Diseases
Shanghai, China
View Trial DetailsNCT06907953
COVID-19, Chronic Disease
New York, United States
View Trial DetailsNCT05940987
Behavior, Chronic Disease
Shanghai, Shanghai Municipality, China
View Trial Details