Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

NCT04490083 | Unknown DMC

• 1 other identifier: CP_ESWLPainrelief
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients having persistent pain

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

  6 months

Interventions

Extra corporeal shock wave lithotripsy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Chronic pancreatitis patients undergoing ESWL

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Manu Tandan

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nitin Jagtap, MD, DNB

  Asian Institute of Gastroenterology, Hyderabad, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Jagtap, MD, DNB

CONTACT

04023378888; docnits13@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)