Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490083
• Other study ID #: CP_ESWLPainrelief
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Asian Institute of Gastroenterology, India
• Contact: Nitin Jagtap, MD, DNB
• Phone: 04023378888
• Email: docnits13[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
India	Manu Tandan	Hyderabad	Telengana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having persistent pain	Patients with persistent pain after 6 months of ESWL will be calculated	6 months