Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
62 participants
INTERVENTIONAL
2016-11-30
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESWL alone
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.
extracorporeal shock wave lithotripsy
People in this group would be treated with ESWL only.
Analgesics
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
ESWL combined with ERCP
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.
endoscopic drainage of the main pancreatic duct
People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
Analgesics
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Interventions
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extracorporeal shock wave lithotripsy
People in this group would be treated with ESWL only.
endoscopic drainage of the main pancreatic duct
People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
Analgesics
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
* no ERCP or ESWL carried out before admission
Exclusion Criteria
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
* age below 18 years;
* pregnancy or lactation;
* refuse to write informed consent
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhuan Liao
Deputy Director
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Yang-Yang Qian, MD
Role: primary
Other Identifiers
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20160801
Identifier Type: -
Identifier Source: org_study_id
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