Upper Abdominal MalignancyNCT02692456
Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis
A study testing Double needle celiac neurolysis (DNCN) and Single needle celiac neurolysis (SNCN) in people with Upper Abdominal Malignancy, run by Mansoura University at 1 site in Egypt.
Trial summary
Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As, it has Cross-section imaging system to avoids anatomic structures injury, it has high density resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal puncture site selection and measured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Abdominal Malignancy
- What is being tested?
- Double needle celiac neurolysis (DNCN) and Single needle celiac neurolysis (SNCN)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gastric carcinoma
- Patients with hepato-biliary-pancreatic cancer
- Patients with colonic malignancy
- Patients with peritoneal metastasis
- Patients with extensive hepatic metastasis
- Patients having intractable pain to opioids and other analgesics.
- Patients experienced adverse effects to opioids or other analgesics.
- Patients experienced improved intractable pain after diagnostic celiac plexus block
Who cannot join
- Patient's refusal
- Patients with bleeding tendency
- Patients with coagulopathy
- Patients who were benefited from oral analgesics with no serious side effects
- Patients with significant cardiac diseases
- Patients with organ failure
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- Patients with distant vertebral metastasis
- Evidence of local infection at the puncture site
- Patients who did not experience improved pain after receiving a diagnostic celiac plexus block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Patient Position After Computerized Tomography Guided Antero-crural Celiac Trunk Neurolysis on Upper Abdominal Malignancy Pain
Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As, it has Cross-section imaging system to avoids anatomic structures injury, it has high density resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal puncture site selection and measured the angle and depth of the needle insertion accurately with display the range of the neurolytic agent diffusion
Read the detailed description
The aim of this study was to evaluate analgesic efficacy of a computerized tomography guided left lateral antero-crural approach near the origin of celiac trunk with patients position on their right side immediately after the procedure using a single needle injection technique for upper abdominal malignancy compared with the classic 2 needle posterior antero-crural injection technique and possible complications.
All patients will take thin computerized tomography section in the axial plane to detect the site of celiac plexus and coronal plane for correct site for needle placement.
Computerized tomography slices thickness will be from 3 mm at 5mm interval through all the abdominal and lower thoracic area. The celiac and superior mesenteric arteries will be identified after contrast injection.
When an ideal needle position and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.
A volume of 3 ml of lidocaine mixed with contrast was injected to confirm the position, after injection another cut has been taken to show the spread of contrast freely in the retro-peritoneal space around the celiac plexus and the aorta. After confirmation, that contrast was injected to surround the artery and make sure that there was no dorsal spread to avoid injury to somatic nerves. Also to make sure that there was no spread to the renal pelvis , injection of phenol 10% mixed with contrast through needle
- Conditions
- Upper Abdominal Malignancy
- Being tested
- Double needle celiac neurolysis (DNCN), Single needle celiac neurolysis (SNCN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double needle celiac neurolysis (DNCN)Device
CT guided celiac neurolysis will be performed using 2 needles inserted on each sides of aorta where patient was positioned in prone position
Single needle celiac neurolysis (SNCN)Device
CT guided celiac neurolysis will be performed through advancing a single needle to justfront of the aorta near the origin of celiac trunk where patient placed in lateral position
| Study group | Role | What they receive |
|---|---|---|
| Double needle celiac neurolysis (DNCN) | Active comparator | Patients were subjected to CT guided celiac neurolysis using 2 needle antero-crural technique on each side with patient in prone position and both needles will be lateral to the aorta Receives: Device: Double needle celiac neurolysis (DNCN) |
| Single needle celiac neurolysis (SNCN) | Placebo comparator | Patients were subjected to CT guided celiac neurolysis using a single needle antero-crural approach from left side to be just in the front of the aorta near the origin of celiac trunk with patient in lateral position with his left side up then after the injection the patient were kept to his right side up for more homogenous spread of the dye. Receives: Device: Single needle celiac neurolysis (SNCN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate of patients positioning
Positioning failure means failure to put patient in prone or lateral position
Measured: For 5 min before needle insertion
Secondary outcomes (2)
Time to achieve analgesia
Time to achieve pain score less than 3
Measured: for one hour after performing the procedure
Failure of block
Failure of block is defined as patient having pain visual analogue scale greater than 3
Measured: For 1 week after performing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Abdominal MalignancyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa A Elmaadawy, MD, Study director, Lecturer of Anesthesia and Surgical Intensive CareGhada F EL-Rahmawy, MD, Principal investigator, Professor of Anesthesia and Surgical Intensive CareNevert A Abdelghaffar, MD, Study chair, lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692456
- Sponsor's protocol ID
- R,∕ 15.07.07
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Patient Position After Computerized Tomography Guided Antero-crural Celiac Trunk Neurolysis on Upper Abdominal Malignancy Pain
- ClinicalTrials.gov ID
- NCT02692456
- Acronym / sponsor ID
- R,∕ 15.07.07
- Conditions
- Upper Abdominal Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2016 (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.
Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As, it has Cross-section imaging system to avoids anatomic structures injury, it has high density resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal puncture site selection and measured the angle and depth of the needle insertion accurately with display the range of the neurolytic agent diffusion
Detailed description
The aim of this study was to evaluate analgesic efficacy of a computerized tomography guided left lateral antero-crural approach near the origin of celiac trunk with patients position on their right side immediately after the procedure using a single needle injection technique for upper abdominal malignancy compared with the classic 2 needle posterior antero-crural injection technique and possible complications.
All patients will take thin computerized tomography section in the axial plane to detect the site of celiac plexus and coronal plane for correct site for needle placement.
Computerized tomography slices thickness will be from 3 mm at 5mm interval through all the abdominal and lower thoracic area. The celiac and superior mesenteric arteries will be identified after contrast injection.
When an ideal needle position and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.
A volume of 3 ml of lidocaine mixed with contrast was injected to confirm the position, after injection another cut has been taken to show the spread of contrast freely in the retro-peritoneal space around the celiac plexus and the aorta. After confirmation, that contrast was injected to surround the artery and make sure that there was no dorsal spread to avoid injury to somatic nerves. Also to make sure that there was no spread to the renal pelvis , injection of phenol 10% mixed with contrast through needle
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double needle celiac neurolysis (DNCN) | Active comparator | Device: Double needle celiac neurolysis (DNCN)Patients were subjected to CT guided celiac neurolysis using 2 needle antero-crural technique on each side with patient in prone position and both needles will be lateral to the aorta |
| Single needle celiac neurolysis (SNCN) | Placebo comparator | Device: Single needle celiac neurolysis (SNCN)Patients were subjected to CT guided celiac neurolysis using a single needle antero-crural approach from left side to be just in the front of the aorta near the origin of celiac trunk with patient in lateral position with his left side up then after the injection the patient were kept to his right side up for more homogenous spread of the dye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with gastric carcinoma
- Patients with hepato-biliary-pancreatic cancer
- Patients with colonic malignancy
- Patients with peritoneal metastasis
- Patients with extensive hepatic metastasis
Key exclusion criteria (9 listed)
- Patient's refusal
- Patients with bleeding tendency
- Patients with coagulopathy
- Patients who were benefited from oral analgesics with no serious side effects
- Patients with significant cardiac diseases
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 |
|---|---|---|
| Double needle celiac neurolysis (DNCN)CT guided celiac neurolysis will be performed using 2 needles inserted on each sides of aorta where patient was positioned in prone position | Device | Double needle celiac neurolysis (DNCN) |
| Single needle celiac neurolysis (SNCN)CT guided celiac neurolysis will be performed through advancing a single needle to justfront of the aorta near the origin of celiac trunk where patient placed in lateral position | Device | Single needle celiac neurolysis (SNCN) |
Primary outcome
Failure rate of patients positioning
Time frame: For 5 min before needle insertion
Positioning failure means failure to put patient in prone or lateral position
2 secondary outcomes
Time to achieve analgesia
Time frame: for one hour after performing the procedure
Failure of block
Time frame: For 1 week after performing the procedure
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 26 Feb 2016.
- 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.
Alaa A Elmaadawy, MD study director
Lecturer of Anesthesia and Surgical Intensive Care
Ghada F EL-Rahmawy, MD principal investigator
Professor of Anesthesia and Surgical Intensive Care
Nevert A Abdelghaffar, MD study chair
lecturer 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 Double needle celiac neurolysis (DNCN) and Single needle celiac neurolysis (SNCN) in people with Upper Abdominal Malignancy, 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 8 inclusion and 9 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 26 Feb 2016. 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?
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?
Failure rate of patients positioning (time frame: For 5 min before needle insertion). 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 26 Feb 2016.