Pancreatic CancerPhase 1NCT01182831
Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
A Phase 1 study testing percutaneous fluoro guided celiac plexus neurolysis and EUS guided neurolysis in people with Pancreatic Cancer, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- percutaneous fluoro guided celiac plexus neurolysis and EUS guided neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients with carcinoma pancreas
Who cannot join
- patients below 18 years of age and who have not given consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500034
Santosh darisetty, MD, +914023378888 ext. 413, sant_dari@yahoo.com
srikar darisetty, MD, +914023378888, srikar.darisetty@gmail.com
About this study
Official title: A Randomized Trial Comparing Fluoroscopy Guided Percutaneous Technique Versus Endoscopic Ultrasound Guided Technique of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. There are limited data comparing the two modalities.The patients are on follow-up for 6 months post neurolysis.
Read the detailed description
Carcinoma pancreas patients with abdominal pain requiring daily analgesics for more than 4 weeks were included.we are randomising about 100 patients into two groups to undergo either of the two procedures, i.e. celiac plexus neurolysis by percutaneous technique or by endoscopic ultrasound guided technique.The pain scores have been recorded by visual analogue scale for an average follow-up of 6 months.
- Conditions
- Pancreatic Cancer
- Being tested
- percutaneous fluoro guided celiac plexus neurolysis, EUS guided neurolysis
- Keywords
- carcinoma pancreas, percutaneous celiac plexus neurolysis, endosonography guided celiac plexus neurolysis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous fluoro guided celiac plexus neurolysisProcedure or surgery
It is percutaneous injection of neurolytic agent in and around the celiac ganglion
EUS guided neurolysisProcedure or surgery
It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous fluoro guided celiac plexus neurolysis | Active comparator | Not described Receives: Procedure: percutaneous fluoro guided celiac plexus neurolysis |
| EUS guided neurolysis | Active comparator | Not described Receives: Procedure: EUS guided neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate pain relief
Measured: day of block to six months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182831
- Sponsor's protocol ID
- AIG-GIA-201001
- Status last verified
- Aug 2010
- First submitted
- 14 Aug 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Fluoroscopy Guided Percutaneous Technique Versus Endoscopic Ultrasound Guided Technique of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
- ClinicalTrials.gov ID
- NCT01182831
- Acronym / sponsor ID
- AIG-GIA-201001
- Conditions
- Pancreatic Cancer
- Keywords
- carcinoma pancreas, percutaneous celiac plexus neurolysis, endosonography guided celiac plexus neurolysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- 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.
Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. There are limited data comparing the two modalities.The patients are on follow-up for 6 months post neurolysis.
Detailed description
Carcinoma pancreas patients with abdominal pain requiring daily analgesics for more than 4 weeks were included.we are randomising about 100 patients into two groups to undergo either of the two procedures, i.e. celiac plexus neurolysis by percutaneous technique or by endoscopic ultrasound guided technique.The pain scores have been recorded by visual analogue scale for an average follow-up of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous fluoro guided celiac plexus neurolysis | Active comparator | Procedure: percutaneous fluoro guided celiac plexus neurolysis |
| EUS guided neurolysis | Active comparator | Procedure: EUS guided neurolysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with carcinoma pancreas
Key exclusion criteria (1 listed)
- patients below 18 years of age and who have not given consent
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 |
|---|---|---|
| percutaneous fluoro guided celiac plexus neurolysisIt is percutaneous injection of neurolytic agent in and around the celiac ganglion | Procedure or surgery | percutaneous fluoro guided celiac plexus neurolysis |
| EUS guided neurolysisIt is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope. | Procedure or surgery | EUS guided neurolysis |
Primary outcome
immediate pain relief
Time frame: day of block to six months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing percutaneous fluoro guided celiac plexus neurolysis and EUS guided neurolysis in people with Pancreatic Cancer, 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 1 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 30 Aug 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immediate pain relief (time frame: day of block to six months of follow-up). 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 30 Aug 2010.