Pain, ChronicNCT03770247
Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer
A study testing Intraoperative celiac plexus neurolysis and CT guided celiac plexus neurolysis in people with Pain, Chronic, run by Mansoura University at 1 site in Egypt.
Trial summary
Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol >5% is also possible to use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Intraoperative celiac plexus neurolysis and CT guided celiac plexus neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled for surgical assessment
- patients proven histololgically to be unresectable
- patients undergoing either biopsy or bypass surgery
Who cannot join
- patient with resectable tumour will be excluded.
- Patient with coagulopathy.
- patient with aortic aneurysm.
- patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university , gastrointestinal surgery center
Al Mansurah, Dakahlia Governorate
About this study
Official title: Direct Intraoperative Injection Versus Percutaneous CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer ; Randomized Controlled Study
Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol >5% is also possible to use. Nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.Surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. Also there is no head to head comparison between the surgical technique and the percutaneous technique.In this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost
Read the detailed description
This study aimed to compare the efficacy of the surgical technique versus the per cutaneous computed tomographic guided technique of celiac plexus neurolysis for pain management in unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass surgery will receive celiac plexus neurolysis either intraoperative or post operative CT guided . All patients will be managed by systemic analgesic if the block not sufficient . In this study we will give the patient the analgesic according to WHO recommendation as starting by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .
- Conditions
- Pain, Chronic
- Being tested
- Intraoperative celiac plexus neurolysis, CT guided celiac plexus neurolysis
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative celiac plexus neurolysisProcedure or surgery
neurolysis of celiac plexus by intraoperative techniques
CT guided celiac plexus neurolysisProcedure or surgery
Neurolysis of celiac plexus percutaneously by CT guidance
| Study group | Role | What they receive |
|---|---|---|
| intraoperative group (IOCPN group) | Experimental | Intraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection. Receives: Procedure: Intraoperative celiac plexus neurolysis |
| CT group (CTCPN group) | Active comparator | CT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection Receives: Procedure: CT guided celiac plexus neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
assesment of efficacy in pain palliation by change in VAS after one month
change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3
Measured: one month
Secondary outcomes (4)
incidence of complication
report the occurrence of complication as headache , diarrhea , vomiting , back pain
Measured: one month
total analgesic consumption
the amount of analgesic required
Measured: 6 month
duration of pain palliation
change of visual analogue scale from baseline for 6 months visual analogue scale represent pain from 0 no pain to 10 maximum pain
Measured: 6 month
need of other injection
if failure of intervention occured patient may need another intervention
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 posted10 Dec 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek M. Shams, MD, Study director, : Professor of Anesthesia and Surgical Intensive CareMahmoud M. Elsedeiq, MSc, Principal investigator, assistan lecturer of Anesthesia and Surgical Intensive CareMohamed A. Ghanim, MD, Study chair, Assistant Professor of Anesthesia and Surgical Intensive CareIbrahim I. Abd El-basir, MD, Study chair, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770247
- Sponsor's protocol ID
- MD ∕ 17.08.53
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2018
- Last updated
- 24 Dec 2019
- 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 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Intraoperative Injection Versus Percutaneous CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer ; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03770247
- Acronym / sponsor ID
- MD ∕ 17.08.53
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Dec 2018 (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.
Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol >5% is also possible to use. Nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.Surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. Also there is no head to head comparison between the surgical technique and the percutaneous technique.In this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost
Detailed description
This study aimed to compare the efficacy of the surgical technique versus the per cutaneous computed tomographic guided technique of celiac plexus neurolysis for pain management in unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass surgery will receive celiac plexus neurolysis either intraoperative or post operative CT guided . All patients will be managed by systemic analgesic if the block not sufficient . In this study we will give the patient the analgesic according to WHO recommendation as starting by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraoperative group (IOCPN group) | Experimental | Procedure: Intraoperative celiac plexus neurolysisIntraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection. |
| CT group (CTCPN group) | Active comparator | Procedure: CT guided celiac plexus neurolysisCT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled for surgical assessment
- patients proven histololgically to be unresectable
- patients undergoing either biopsy or bypass surgery
Key exclusion criteria (4 listed)
- patient with resectable tumour will be excluded.
- Patient with coagulopathy.
- patient with aortic aneurysm.
- patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .
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 |
|---|---|---|
| Intraoperative celiac plexus neurolysisneurolysis of celiac plexus by intraoperative techniques | Procedure or surgery | intraoperative group (IOCPN group) |
| CT guided celiac plexus neurolysisNeurolysis of celiac plexus percutaneously by CT guidance | Procedure or surgery | CT group (CTCPN group) |
Primary outcome
assesment of efficacy in pain palliation by change in VAS after one month
Time frame: one month
change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3
4 secondary outcomes
incidence of complication
Time frame: one month
total analgesic consumption
Time frame: 6 month
duration of pain palliation
Time frame: 6 month
need of other injection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- 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.
Tarek M. Shams, MD study director
: Professor of Anesthesia and Surgical Intensive Care
Mahmoud M. Elsedeiq, MSc principal investigator
assistan lecturer of Anesthesia and Surgical Intensive Care
Mohamed A. Ghanim, MD study chair
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative celiac plexus neurolysis and CT guided celiac plexus neurolysis in people with Pain, Chronic, run by Mansoura 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assesment of efficacy in pain palliation by change in VAS after one month (time frame: one month). 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 24 Dec 2019.