Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis

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Brief Title

Comparison of ESWL Alone and ESWL + Endoscopy for Painful Chronic Pancreatitis

Official Title

Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Relapse of pain at 2 years

Secondary Outcome

 Diameter of the main pancreatic duct at 1 month

Condition

Pancreatitis

Intervention

Extracorporeal shock wave lithotripsy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

March 1998

Completion Date

February 21, 2022

Primary Completion Date

February 21, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Marc Dumonceau, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00133835

Organization ID

97.187


Responsible Party

Sponsor

Study Sponsor

Erasme University Hospital


Study Sponsor

Jean-Marc Dumonceau, Principal Investigator, University Hospital, Geneva


Verification Date

July 2005