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The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.
The combination mode of ESWL and ERCP is an established method of treatment of painful obstructive calcified chronic pancreatitis. However, the investigators notice that patients after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of the pancreatic pain.
So the investigators design such a prospective and randomized controlled trial. People diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random numbers.
ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions will be repeated if necessary, until stone fragmentation is obtained. Patients in the endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.
Follow-up will consists of telephone interview1 after treatment and clinical examination every 6 months thereafter. Data collected will include clinical presentation, ESWL, endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6 months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWL alone | Experimental | Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded. |
|
| ESWL combined with ERCP | Active Comparator | People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extracorporeal shock wave lithotripsy | Procedure | People in this group would be treated with ESWL only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pain score as accessed by izbichi pain score at 12 month | Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit | Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, that is exocrine function normal, PEI develop, PEI resolve, PEI persist. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | Complications involve pancreatitis, hemorrhage, perforation, infection and steinstrasse. | 1 months |
| endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao-shen Li | Contact | zhaoshen-li@hotmail.com | ||
| Zhuan Liao | Contact | liaozhuan@smmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D008096 | Lithotripsy |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D002758 | Cholangiography |
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| endoscopic drainage of the main pancreatic duct | Procedure | People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours. |
|
|
| Analgesics | Drug | Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed. |
|
| clearance of pancreatic stones |
Clearance of pancreatic stone is regarded as complete when clearance rate is more than 90%, partial is regarded as 50% to 90%, the rest is unsuccessful. |
| 12 months |
| decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP | 12 months |
As mentioned earlier, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
| 12 months |
| treatment-related cost from initial treatment to the end of the study(12 months) | 12 months |
| life quality as assessed by SF-36 questionnaire | 12 months |
| BMI in kg/m^2 | 12 months |
| Shanghai Changhai Hospital | Recruiting | Shanghai | China |
|
| 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 |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |