Treatment Strategy of Pancreatic Radiolucent Stone

Study Overview
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Brief Summary
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Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

Detailed Description
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1. Treatment strategy of CP patients with large pancreatic stone： . For patients with large radiolucent stone，ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent. . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended. 2. A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time. 3. The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

Official Title
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A Prospective Cohort Study of Large Pancreatic Radiolucent Stone

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm Exclusion Criteria: Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| radiolucent stone group<br> | Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy<br> <br> |
| radiopaque stone group<br> | Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of pain relief | Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score > 10 after a decrease of > 50%) | after treatment to 2020-01-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of stone clearance | Rate of stone clearance is evaluated by ERCP as follows: a) complete clearance as clearance of > 90% of stone volume; b) partial clearance as clearance of 50%-90% of stone volume; c) unsuccessful clearance as less than 50% clearance of stone volume | during ERCP procedure | 
| score of life quality | Quality of life score was a subjective evaluation index of patient which ranged from 0 to 100, with higher score indicating a better quality of life | after treatment to 2020-01-30 |