Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• India
  • Telengana
    • Hyderabad, Telengana, India, 500082
      • Recruiting
      • Manu Tandan
      • Contact: Praneeth Kumar, MD; Phone Number: 914023378888; Email: praneethkumar.chandragiri1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population will be prospectively enrolled from patients with chronic pancreatitis undergoing ESWL in hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients having persistent pain	Patients with persistent pain after 6 months of ESWL will be calculated	6 months

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Nitin Jagtap, MD, DNB, Asian institute of Gastroenterology, hyderabad, India

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: CP_ESWLPainrelief

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No