Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

• Sponsor: Asian Institute of Gastroenterology, India (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04490083
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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	Phase
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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Jun 30, 2021

Outcome Measures

Primary Outcome Measures

1. Percentage of patients having persistent pain [6 months]

   Patients with persistent pain after 6 months of ESWL will be calculated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Manu Tandan	Hyderabad	Telengana	India	500082

Sponsors and Collaborators

• Asian Institute of Gastroenterology, India

Investigators

• Principal Investigator: Nitin Jagtap, MD, DNB, Asian Institute of Gastroenterology, Hyderabad, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT04490083
• Other Study ID Numbers: CP_ESWLPainrelief
• First Posted: Jul 28, 2020
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Jul 28, 2020