Clinical trial NCT02971475: ESWL Versus ESWL and Endoscopic Treatment
Official title: Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis
Keywords: Extracorporeal Shock Wave lithotripsy(ESWL)
Endoscopic Retrograde Cholangiopancreatography(ERCP)
chronic pancreatitis
pain relief
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
* 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:

* suspected to have malignant tumors;
* 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

Primary outcomes:
measure: Change from baseline pain score as accessed by izbichi pain score at 12 month
timeFrame: 12 months
Secondary outcomes:
measure: exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit
timeFrame: 12 months
measure: clearance of pancreatic stones
timeFrame: 12 months
measure: decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP
timeFrame: 12 months
Other outcomes:
measure: complication rate
timeFrame: 1 months
measure: endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin
timeFrame: 12 months
measure: treatment-related cost from initial treatment to the end of the study(12 months)
timeFrame: 12 months
measure: life quality as assessed by SF-36 questionnaire
timeFrame: 12 months
measure: BMI in kg/m^2
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
References: