Chronic PancreatitisNCT04490083
Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL
An observational study of Chronic Pancreatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Extra corporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2020to 30 Jun 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be prospectively enrolled from patients with chronic pancreatitis undergoing ESWL in hospital.
Who may be able to join
- Chronic pancreatitis patients undergoing ESWL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Manu Tandan
Hyderabad, Telangana, 500082
Praneeth Kumar, MD, 914023378888, praneethkumar.chandragiri1@gmail.com
Nitin Jagtap, MD, DNB, 914023378888, docnits13@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Extra corporeal shock wave lithotripsy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra corporeal shock wave lithotripsyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients having persistent pain
Patients with persistent pain after 6 months of ESWL will be calculated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Jagtap, MD, DNB, Principal investigator, Asian Institute of Gastroenterology, Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490083
- Sponsor's protocol ID
- CP_ESWLPainrelief
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT04490083
- Acronym / sponsor ID
- CP_ESWLPainrelief
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be prospectively enrolled from patients with chronic pancreatitis undergoing ESWL in hospital.
Key inclusion criteria (1 listed)
- Chronic pancreatitis patients undergoing ESWL
Key exclusion criteria (7 listed)
- Patients with multiple pancreatic duct stones
- Patients with multiple pancreatic duct strictures
- Pancreatic head mass
- Patients with ascites
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra corporeal shock wave lithotripsyESWL 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. | Procedure or surgery | – |
Primary outcome
Percentage of patients having persistent pain
Time frame: 6 months
Patients with persistent pain after 6 months of ESWL will be calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Jagtap, MD, DNB principal investigator
Asian Institute of Gastroenterology, Hyderabad, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitin Jagtap, MD, DNB (04023378888, docnits13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients having persistent pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.