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Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

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ClinicalTrials.gov Identifier: NCT04490083
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India

Study Description
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Brief Summary:

Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal in 70% patients, associated with 85 to 90% pain relief.

Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out which patients will improve and which patients won't improve in terms of pain.


Condition or disease Intervention/treatment
Chronic Pancreatitis Procedure: Extra corporeal shock wave lithotripsy

Detailed Description:

The study will be a single center observational study.

General information of the patient in form of duration of symptoms and duration of diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct stone,size,parenchymal calcification , ductal stricture and its location, using any medications such as antioxidants and pain killers .

The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will receive standard of care during study period, and they won't receive any experimental therapy.

After 6months of ESWL further general information of the patient any addictions, a formal imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and also usage of any medications for decreasing pain.

Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and information investigators will evaluate predictive factors of pain relief after ESWL by logistic regression.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis Shock

Groups and Cohorts
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Intervention Details:
  • Procedure: Extra corporeal shock wave lithotripsy
    ESWL will be performed with a third generation electromagnetic lithotripter (Delta Compact, Dornier Med Tech, Germany) This has both fluoroscopy and ultrasound imaging facility. Radio opaque calculi will be targeted directly while a naso pancreatic tube (NPT) was placed for all radiolucent calculi and contrast was passed through this to localize the calculi. Between 5000 and 6000 shocks were delivered per session with frequency of 90 shocks per minute. The aim will be to fragment the calculi to <3 mm or demonstrate a decrease in heterogeneity or density of the calculi in the main pancreatic duct. Shocks will be delivered on consecutive days till fragmentation is achieved. If there is no fragmentation after four sessions of ESWL the procedure will be labeled as unsuccessful and patient will be advised surgery. Procedures will be performed under epidural anesthesia.

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients having persistent pain [ Time Frame: 6 months ]
    Patients with persistent pain after 6 months of ESWL will be calculated


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will be prospectively enrolled from patients with chronic pancreatitis undergoing ESWL in hospital.
Criteria

Inclusion Criteria:

  • Chronic pancreatitis patients undergoing ESWL

Exclusion Criteria:

  • Patients with multiple pancreatic duct stones
  • Patients with multiple pancreatic duct strictures
  • Pancreatic head mass
  • Patients with ascites
  • Pregnancy
  • Patients not giving consent for participation
  • Pseudocyst
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490083


Contacts
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Contact: Nitin Jagtap, MD, DNB 04023378888 docnits13@gmail.com

Locations
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India
Manu Tandan Recruiting
Hyderabad, Telengana, India, 500082
Contact: Praneeth Kumar, MD    914023378888    praneethkumar.chandragiri1@gmail.com   
Contact: Nitin Jagtap, MD, DNB    914023378888    docnits13@gmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: Nitin Jagtap, MD, DNB Asian Institute of Gastroenterology, Hyderabad, India
More Information
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Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT04490083    
Other Study ID Numbers: CP_ESWLPainrelief
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases