Clinical trial NCT05326542: Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP
Official title: ESWL Combined With ERCP and Laser Lithotripsy Combined With ERCP In Treatment of Pancreatic Duct Stones With Chronic Pancreatitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis, Chronic
Pancreatic Duct Stone
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Lithotripsy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 80
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 ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with 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 by using basket and/or balloon catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct stones (diameter \< 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL).

ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone.

In view of the fact that there is no relevant research comparing the overall efficacy of ESWL combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for PD stones. This research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.

Eligibility criteria: Inclusion Criteria:

* symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
* at least one stone (\>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
* dilation of the proximal pancreatic duct.

Exclusion Criteria:

* history of ERCP or ESWL treatment;
* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* pancreatic pseudocyst with a diameter \>4cm;
* bile duct stricture secondary to cholangitis or chronic pancreatitis;
* acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
* 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: technical success rates
timeFrame: during ERCP procedure
measure: clearance rates of pancreatic duct stones
timeFrame: during ERCP procedure
Secondary outcomes:
measure: time taken to completely clear the stone
timeFrame: during ESWL and ERCP procedure
measure: postoperative complications
timeFrame: 30 days after ERCP procedure
measure: success rates of pancreatic duct decompression
timeFrame: during 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.