Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis
Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis
Endoscopy is an established method of treatment for painful obstructive calcified
 pancreatitis. It involves the disintegration of calcifications using extracorporeal shock
 wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments possibly associated
 with stent insertion. A pilot study suggests that ESWL alone relieves pain in calcified
 chronic pancreatitis (CP). The aim of this study is to compare both techniques in a
 randomized controlled trial.
Endoscopic drainage of the main pancreatic duct is an established method of treatment of
 painful obstructive calcified chronic pancreatitis (CP). It involves disintegration of
 calcifications using extracorporeal shock wave lithotripsy (ESWL) followed by endoscopic
 removal of stone fragments, possibly associated with stent insertion. A pilot study suggests
 that ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and
 pain relief, without sphincterotomy. After ESWL alone, the exocrine function was found to
 return to normal values in some cases. Potential benefits include lower costs and morbidity
 as well as wider availability compared to endoscopic techniques.

 The primary outcome of this randomized controlled trial is to compare the relapse of pain at
 2 years after treatment with ESWL alone or endoscopic treatment, consisting of ESWL followed
 by endoscopic stone extraction. Secondary outcomes include a comparison of technical results
 (as assessed by abdominal CT Scan 1 week after the last intervention and secretin-enhanced
 magnetic resonance at 1 month), complication rates, and treatment-related costs in both
 groups.

 Patients are eligible to participate in the study according to the following criteria:

 Inclusion criteria :

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

 -  at least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or
 corporeal portion of the main pancreatic duct with upstream duct dilation;

 -  written informed consent obtained from the patient.

 Exclusion criteria:

 -  history of treatment of the pancreas using ESWL, endoscopy, or surgery;

 -  pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT Scan;

 -  alkaline phosphatase levels greater than twice the upper limit of normal values or signs
 of cholangitis;

 -  age below 18 years;

 -  pregnancy or lactation.

 Pretherapeutic work-up will include detailed medical history (including date of the first
 episode of typical abdominal pain, date of diagnosis of CP, number of episodes of pain during
 the last year, alcohol intake, pain continuous or intermittent during the last episode,
 medication, intensity of the last episode of pain on a 10-point scale as previously
 described), blood chemistry, stool sampling (for elastase measurement), triolein breath test,
 plain abdominal film taken in four classical positions (left anterior oblique, right anterior
 oblique, lateral, and supine), CT Scan without contrast medium injection, and
 secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP).

 After informed consent of the referring physician has been obtained, patients will be asked
 to participate in the study. If the patient accepts, after oral and written consent, he (or
 she) will be randomized to the ESWL or endoscopy group by opening an opaque sealed envelope
 numbered according to a table of random numbers.

 ESWL will be performed in all patients using a electromagnetic lithotriptor as previously
 described. Shock-waves will be focused on the obstructing stones (if multiple stones are
 present, those responsible for MPD obstruction will be identified by comparing plain
 abdominal film, CT Scan and S-MRCP). ESWL sessions will be repeated if necessary, until stone
 fragmentation is obtained, as confirmed by abdominal plain film centered on the targeted area
 of the pancreas. At this time, treatment will be considered terminated in the ESWL group,
 patients in the endoscopy group will undergo endoscopy immediately, for endoscopic extraction
 of stone fragments possibly associated to stent insertion according to previously published
 criteria and techniques.

 Cross-over: in the ESWL group, if no elimination of the fragments is observed one week after
 the last ESWL, endoscopic drainage of the main pancreatic duct will be carried out at this
 time in case of continuous pain. For patients without continuous pain, delayed spontaneous
 elimination of the fragments will be sought by CT Scan and S-MRCP 2 months after the last
 ESWL. Endoscopic drainage of the main pancreatic duct will be proposed during follow-up only
 to the patients presenting a painful attack of CP.

 Follow-up will consist of clinical examination 1 month after treatment and every 6 months
 thereafter. Data collected will include pain relapses, ESWL, endoscopic and surgical
 procedures, weight change, plus any other seemingly unrelated medical treatments. In addition
 to this, a S-MRCP will be performed 1 month after treatment. Triolein breath test will be
 performed at 1 month and 1 year. Sampling of stools (for elastase measurement) will be
 obtained every year.

 Costs will be calculated starting on the day of first treatment as previously described.
 Costs not directly related to the treatment of pain or of procedure-related complications
 (e.g., diabetes) will be disregarded.
Inclusion Criteria:

 -  Painful chronic pancreatitis (>1 abdominal pain attack during the preceding 12 months)

 -  At least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or
 corporeal portion of the main pancreatic duct (MPD) with upstream duct dilation

 -  Written informed consent obtained from the patient

 Exclusion Criteria:

 -  History of treatment of the pancreas using ESWL, endoscopy, or surgery

 -  Pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan

 -  Alkaline phosphatase levels greater than twice the upper limit of normal values or
 signs of cholangitis

 -  Age below 18 years

 -  Pregnancy or lactation