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This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWL and ERCP | Experimental | 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. |
|
| LL and ERCP | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESWL and ERCP | Procedure | First, ESWL will be used for lithotripsy, and then ERCP will be performed to clear the stones after lithotripsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| technical success rates | Technical success rates refer to the successful completion of standard procedures or the occurrence of complete spontaneous stone removal. | during ERCP procedure |
| clearance rates of pancreatic duct stones | Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively. | during ERCP procedure |
| Measure | Description | Time Frame |
|---|---|---|
| time taken to completely clear the stone | The time taken to completely clear the stones. | during ESWL and ERCP procedure |
| postoperative complications | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| abdominal pain relief rate | 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). | 30 days after ERCP procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang-hao Hu, MD | Contact | +86-13817593520 | ianghao-hu@smmu.edu.cn | |
| Zhao-shen Li, MD | Contact | +86-13901960921 | zhaoshen-li@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang-hao Hu, MD | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31238312 | Background | 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. |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008096 | Lithotripsy |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D002758 | Cholangiography |
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| LL and ERCP | Procedure | After establishing the working channel under ERCP, the stone will be crushed with a laser lithotripter, and then ERCP will clear the stones after lithotripsy. |
|
| 30 days after ERCP procedure |
| success rates of pancreatic duct decompression | Successful removal of pancreatic duct obstruction factors by clearing stones and/or placing pancreatic duct stents/nasopancreatic catheters. | during ERCP procedure |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |