Chronic PainNCT03886298

Radiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain

A study testing radiofrequency splanchnic denervation and retrocrural celiac denervation in people with Chronic Pain, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The investigators will evaluate the analgesic efficacy of radiofrequency splanchnic nerve denervation versus neurolytic retrocrural celiac denervation for patients with abdominal pain due to cancer pancreas Read more about this study

Who is it for?: Ages 16 to 90 years
Conditions the study is for: Chronic Pain
What is being tested?: radiofrequency splanchnic denervation and retrocrural celiac denervation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 10 Apr 2019to 10 Jun 2020
Phase: Interventional
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 16 to 90 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients with abdominal pain due to cancer pancreas

Who cannot join

coagulopathy
infection at site of the procedure

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

Diab
Asyut, Assuit, 71515
Diab Hetta, MD, +201091090009, diabgetta25@gmail.com
Recruiting

Other trials in Egypt

About this study

Official title: For Patients With Pancreatic Cancer Pain, Does Radiofrequency Splanchnic Denervation Isprovide a Similar Analgesia as Neurolytic Celiac Block

Conditions: Chronic Pain
Being tested: radiofrequency splanchnic denervation, retrocrural celiac denervation
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

radiofrequency splanchnic denervationProcedure or surgery
the authors will denervate the splanchnic nerves via radiofrequency
retrocrural celiac denervationProcedure or surgery
the authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol

Study groups in NCT03886298
Study group	Role	What they receive
radiofrequency splanchnic denervation	Experimental	Not described Receives: Procedure: radiofrequency splanchnic denervation
retrocrural celiac denervation	Active comparator	Not described Receives: Procedure: retrocrural celiac denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

the percentage of patients that gain more than 50% reduction of their pain on VAS pain score
VAS pain scale is a tool for measurement of pain intensity scored from 0 to 10 in which 0 + no pain and 10 + the worst pain immaginable
Measured: 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201910 Jun 2020

First posted22 Mar 2019
Study start10 Apr 2019
Primary completion10 Apr 2020 (estimated)
Study completion10 Jun 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03886298
Sponsor's protocol ID: SECI-IRB-IORG0009563-725
Status last verified: Jul 2019
First submitted: 20 Mar 2019
Last updated: 8 Jul 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: For Patients With Pancreatic Cancer Pain, Does Radiofrequency Splanchnic Denervation Isprovide a Similar Analgesia as Neurolytic Celiac Block
ClinicalTrials.gov ID: NCT03886298
Acronym / sponsor ID: SECI-IRB-IORG0009563-725
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 10 Apr 2019 (actual)
Primary completion: 10 Apr 2020 (estimated)
Study completion: 10 Jun 2020 (estimated)
First posted: 22 Mar 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
radiofrequency splanchnic denervation	Experimental	Procedure: radiofrequency splanchnic denervation
retrocrural celiac denervation	Active comparator	Procedure: retrocrural celiac denervation

Who may qualify

Ages: 16 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

patients with abdominal pain due to cancer pancreas

Key exclusion criteria (2 listed)

coagulopathy
infection at site of the procedure

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
radiofrequency splanchnic denervationthe authors will denervate the splanchnic nerves via radiofrequency	Procedure or surgery	radiofrequency splanchnic denervation
retrocrural celiac denervationthe authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol	Procedure or surgery	retrocrural celiac denervation

Primary outcome

the percentage of patients that gain more than 50% reduction of their pain on VAS pain score
Time frame: 6 months postoperatively
VAS pain scale is a tool for measurement of pain intensity scored from 0 to 10 in which 0 + no pain and 10 + the worst pain immaginable

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Pain

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RecruitingObservational study
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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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.

Diab

Asyut, Egypt

+201091090009

diabgetta25@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing radiofrequency splanchnic denervation and retrocrural celiac denervation in people with Chronic Pain, run by Assiut University at 1 site in Egypt.

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 2 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 8 Jul 2019. 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 Egypt. 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?

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?

the percentage of patients that gain more than 50% reduction of their pain on VAS pain score (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03886298.

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 8 Jul 2019.