Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL
NCT ID: NCT04490083
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2020-07-01
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis
NCT03966781
ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
NCT04158297
ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
NCT04115826
Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis
NCT07074379
Comparison of ESWL Alone and ESWL + Endoscopy for Painful Chronic Pancreatitis
NCT00133835
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with multiple pancreatic duct strictures
* Pancreatic head mass
* Patients with ascites
* Pregnancy
* Patients not giving consent for participation
* Pseudocyst
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asian Institute of Gastroenterology, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nitin Jagtap, MD, DNB
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology, Hyderabad, India
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Manu Tandan
Hyderabad, Telangana, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP_ESWLPainrelief
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.