Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP

Naval Military Medical University

Status: Not yet enrolling

Conditions: Pancreatitis, Chronic; Pancreatic Duct Stone

Treatments: Procedure: LL and ERCP; Procedure: ESWL and ERCP

Study type: Interventional

Funder types: Other

Identifiers

NCT05326542

ECLIPSE20220312

Details and patient eligibility

About

This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

ESWL and ERCP

Experimental group

Description:

The patients will receive intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP will be greater than 48h. 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 will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary.

Treatment:

Procedure: ESWL and ERCP

LL and ERCP

Active Comparator group

Description:

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 will be performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. After that, laser lithotripsy will be performed. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent or a nasopancreatic catheter will be inserted for temporary drainage if necessary.

Treatment:

Procedure: LL and ERCP