Abdominal CancerRFNCT03063112
Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain
A study testing Radiofrequency generator device, Lidocaine and C arm fluoroscopic device in people with Abdominal Cancer, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Radiofrequency generator device, Lidocaine and C arm fluoroscopic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 1 May 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from upper abdominal cancer pain.
- Visceral pain with visual analogue pain score ≥ 4.
- Normal coagulation profile.
- Positive diagnostic test.
- Written informed consent from the patients .
Who cannot join
- Patients with organ failure.
- Coagulation disorders.
- Local infection at the puncture site or sepsis.
- Allergy to the contrast dye or alcohol.
- Severe displacement of intra-abdominal structures.
- Pregnant women.
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- Documented metastatic lesions.
- Psychiatric illness affecting cooperation.
- De-compensated cardiac disorders.
- Liver and renal dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, Assuit Governrate, +20
Mostafa M Esharkawy, Professor, 0882332016, sru@seci.info
Doaa M Sayed, Professor, 0882086671, seci99999@gmail.com
About this study
Official title: Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.
Read the detailed description
Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.
- Conditions
- Abdominal Cancer
- Being tested
- Radiofrequency generator device, Lidocaine, C arm fluoroscopic device, Ethyl alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency generator deviceDevice
Also called Physical neurolysis
sympathetic blockade or ablation of thoracic splanchnic nerves
LidocaineDrug
sympathetic blockade or ablation of thoracic splanchnic nerves
C arm fluoroscopic deviceDevice
sympathetic blockade or ablation of thoracic splanchnic nerves
Ethyl alcoholDrug
Also called Chemical neuolysis
sympathetic blockade or ablation of thoracic splanchnic nerves
| Study group | Role | What they receive |
|---|---|---|
| Group 1( radiofrequency group ) | Active comparator | Bilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion Receives: Device: Radiofrequency generator device; Drug: Lidocaine |
| Group 2 ( alcohol group ) | Placebo comparator | Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device. Receives: Device: C arm fluoroscopic device; Drug: Ethyl alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Visual analogue pain scale
Measured: 3 months
Secondary outcomes (1)
Decrease the need for analgesic drugs
Reduction of total oral morphine consumption dose in mg per day
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Oct 2016
- Primary completion10 Apr 2017 (estimated)
- Study completion1 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Al Zahraa Hamed Abdel Hameed, South Egypt Cancer Institute
- Investigators
- Samy A Erfan, Professor, Study director, Head of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063112
- Sponsor's protocol ID
- Ethical committee 167
- Acronym
- RF
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
- ClinicalTrials.gov ID
- NCT03063112
- Acronym / sponsor ID
- RF / Ethical committee 167
- Conditions
- Abdominal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 10 Apr 2017 (estimated)
- Study completion
- 1 May 2017 (estimated)
- First posted
- 24 Feb 2017 (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.
The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.
Detailed description
Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1( radiofrequency group ) | Active comparator | Device: Radiofrequency generator device, Drug: LidocaineBilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion |
| Group 2 ( alcohol group ) | Placebo comparator | Device: C arm fluoroscopic device, Drug: Ethyl alcoholBilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from upper abdominal cancer pain.
- Visceral pain with visual analogue pain score ≥ 4.
- Normal coagulation profile.
- Positive diagnostic test.
- Written informed consent from the patients .
Key exclusion criteria (10 listed)
- Patients with organ failure.
- Coagulation disorders.
- Local infection at the puncture site or sepsis.
- Allergy to the contrast dye or alcohol.
- Severe displacement of intra-abdominal structures.
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 generator deviceAlso: Physical neurolysissympathetic blockade or ablation of thoracic splanchnic nerves | Device | Group 1( radiofrequency group ) |
| Lidocainesympathetic blockade or ablation of thoracic splanchnic nerves | Drug | Group 1( radiofrequency group ) |
| C arm fluoroscopic devicesympathetic blockade or ablation of thoracic splanchnic nerves | Device | Group 2 ( alcohol group ) |
| Ethyl alcoholAlso: Chemical neuolysissympathetic blockade or ablation of thoracic splanchnic nerves | Drug | Group 2 ( alcohol group ) |
Primary outcome
Pain relief
Time frame: 3 months
Visual analogue pain scale
1 secondary outcome
Decrease the need for analgesic drugs
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Samy A Erfan, Professor study director
Head of the department
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 generator device, Lidocaine and C arm fluoroscopic device in people with Abdominal Cancer, run by South Egypt Cancer Institute 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 5 inclusion and 10 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 Feb 2017. 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. Some participants in this study may receive a placebo. 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 Fatma Al Zahraa H Abdel Hameed, Lecturer (0201063684819, drfatmahamed15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 3 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 Feb 2017.