Clinical trial NCT05289362: Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis, Chronic
Pancreatic Duct Stone
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clearance rates of pancreatic duct stones
timeFrame: during ERCP procedure
Secondary outcomes:
measure: timeout rate
timeFrame: during ERCP procedure
measure: time taken to completely clear the stone
timeFrame: during ERCP procedure
measure: number of times to completely clear the stone
timeFrame: during ERCP procedure
measure: post-ERCP complications
timeFrame: 30 days after ERCP procedure
Other outcomes:
measure: abdominal pain relief rate
timeFrame: 30 days after ERCP procedure
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hu 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.