ESWL Versus ESWL and Endoscopic Treatment

May 30, 2018 updated by: Zhuan Liao, Changhai Hospital

Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
          • Yang-Yang Qian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: extracorporeal shock wave lithotripsy
People in this group would be treated with ESWL only.
Other Names:
  • ESWL
Drug: Analgesics
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Active Comparator: 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.
Drug: Analgesics
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Procedure: endoscopic drainage of the main pancreatic duct
People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
Other Names:
  • ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline pain score as accessed by izbichi pain score at 12 month
Time Frame: 12 months
Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit
Time Frame: 12 months
Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, that is exocrine function normal, PEI develop, PEI resolve, PEI persist.
12 months
clearance of pancreatic stones
Time Frame: 12 months
Clearance of pancreatic stone is regarded as complete when clearance rate is more than 90%, partial is regarded as 50% to 90%, the rest is unsuccessful.
12 months
decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI in kg/m^2
Time Frame: 12 months
12 months
complication rate
Time Frame: 1 months
Complications involve pancreatitis, hemorrhage, perforation, infection and steinstrasse.
1 months
endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin
Time Frame: 12 months
As mentioned earlier, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
12 months
treatment-related cost from initial treatment to the end of the study(12 months)
Time Frame: 12 months
12 months
life quality as assessed by SF-36 questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

November 19, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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