ESWL Versus ESWL and Endoscopic Treatment

Naval Military Medical University

Status: Unknown

Conditions: Pancreatitis

Treatments: Drug: Analgesics; Procedure: endoscopic drainage of the main pancreatic duct; Procedure: extracorporeal shock wave lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02971475

20160801

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

ESWL alone

Experimental group

Description:

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.

Treatment:

Procedure: extracorporeal shock wave lithotripsy

Drug: Analgesics

ESWL combined with ERCP

Active Comparator group

Description:

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.

Treatment:

Drug: Analgesics

Procedure: endoscopic drainage of the main pancreatic duct