Cancer PainNCT07445386
Transdiscal vs Paravertebral Neurolytic Splanchnic Nerve Block for Upper Abdominal Cancer Pain
A study testing transdiscal splanchnic neurolysis and paravertebral splanchnic neurolysis in people with Cancer Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- transdiscal splanchnic neurolysis and paravertebral splanchnic neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Severe abdominal pain (NRS > 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).
- Failure of pain control with conservative treatment modalities.
Who cannot join
- Presence of local anatomical variations
- Localized or systemic infection involving the procedural site
- Pregnancy
- Coagulopathy
- Presence of unstable psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara
Gokhan Yildiz, 5059272589 ext. TR, gkoyldz@gmail.com
About this study
Official title: Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain
This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.
Read the detailed description
Cancer-related pain (CRP) is a complex and challenging condition to manage. Pain may be somatic, visceral, or neuropathic in origin, and more than 50% of patients present with a mixed pain pattern at the time of diagnosis. In addition to medical therapies such as opioids and adjuvant analgesics, various interventional procedures are used in the management of CRP. Among these, neurolytic nerve and plexus blocks represent effective options for patients with pain refractory to conservative treatment. Chemical neurolysis, as a minimally invasive neurolytic plexus block technique, provides effective analgesia by targeting both sensory afferent fibers and sympathetic fibers innervating visceral organs. Identifying the most appropriate block according to pain localization plays a crucial role in achieving successful pain control.
Splanchnic nerve neurolysis is an established interventional technique for the management of upper abdominal cancer pain associated with pancreatic, gastric, and hepatic malignancies. Both the paravertebral (PV) and transdiscal (TD) approaches have been shown to effectively reduce cancer-related abdominal pain and significantly improve quality of life in affected patients. However, comparative data between these two techniques remain limited.
The primary aim of this study is to compare the efficacy of paravertebral (PV) and transdiscal (TD) splanchnic nerve neurolysis in patients with severe upper abdominal cancer pain refractory to medical therapy, using the Numerical Rating Scale (NRS) for pain assessment. Secondary aims include evaluating the impact of these techniques on quality of life using the EORTC QLQ-C30 questionnaire, comparing changes in opioid consumption, comparing procedure duration and fluoroscopy imaging time, and determining the incidence of adverse events.
A total of 56 patients, 28 in each group, will be enrolled. Pain intensity will be assessed using the NRS before the procedure and at 3 days, 1 month, and 3 months after the intervention. Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire before the procedure and at 1 and 3 months post-intervention. Procedure-related adverse events will be recorded.
- Conditions
- Cancer Pain
- Being tested
- transdiscal splanchnic neurolysis, paravertebral splanchnic neurolysis
- Keywords
- Splanchnic Nerves, Nerve Block, Abdominal Pain, Pancreatic Neoplasms, Liver Neoplasms
- Medical subject headings
- Cancer Pain, Abdominal Pain, Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdiscal splanchnic neurolysisProcedure or surgery
With the patient in the prone position, the T11-T12 vertebral levels were identified under anteroposterior fluoroscopic guidance, and the C-arm was adjusted to align the superior and inferior endplates of the T11-T12 intervertebral disc. The fluoroscope was then rotated obliquely to position the tip of the T12 superior articular process at the midpoint of the T11 vertebral body. After local anesthesia with 2 mL of 1% lidocaine, a spinal needle was advanced to the target point. The ideal final needle position was at the center of the intervertebral disc on the anteroposterior view and at the anterior border of the vertebral body on the lateral view. Correct needle placement was confirmed fluoroscopically, followed by injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 10 mL of 1% lidocaine resulting in >50% pain relief, 10 mL of 96% alcohol was slowly injected for neurolysis.
paravertebral splanchnic neurolysisProcedure or surgery
Under C-arm fluoroscopic guidance, the inferior border of the T11 vertebral body was used as a reference, and the fluoroscope was adjusted to a 15-20° craniocaudal and approximately 15-20° oblique angle. The needle entry point was selected slightly inferior to the T11 transverse process, and after local anesthesia with 2 mL of 1% lidocaine, the spinal needle was advanced along the lateral aspect of the vertebral body. On lateral fluoroscopic view, the needle tip was positioned at the anterior two-thirds of the vertebral body. Correct needle placement was confirmed fluoroscopically, followed by negative aspiration and injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 5 mL of 1% lidocaine resulting in >50% pain relief, 5 mL of 96% alcohol was slowly injected for neurolysis. The same procedure was repeated contralaterally, resulting in a total of 10 mL of 96% alcohol.
| Study group | Role | What they receive |
|---|---|---|
| transdiscal splanchnic neurolysis group | Active comparator | Transdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain Receives: Procedure: transdiscal splanchnic neurolysis |
| paravertebral splanchnic neurolysis group | Active comparator | Paravertebral splanchnic neurolysis for upper gastrointestinal malignancy pain Receives: Procedure: paravertebral splanchnic neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to post-treatment day 3, and at 1 and 3 months.
Secondary outcomes (2)
EORTC QLQ-C30 questionnaire
The EORTC QLQ-C30 questionnaire is used to assess health-related quality of life in patients with cancer. It consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures. Scores are linearly transformed to a 0-100 scale. Higher scores on functional and global health scales indicate better quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
Measured: Change from baseline to 1st and 3rd month after treatment
Fluoroscopy imaging time
Fluoroscopy imaging time is used as a secondary outcome to evaluate procedural exposure. It is defined as the total duration of active fluoroscopic imaging, measured in seconds, from the first fluoroscopic image acquisition to the final image obtained during the procedure.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start16 Feb 2026
- Primary completion16 Aug 2026 (estimated)
- Study completion16 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Yıldız, Ankara Etlik City Hospital
- Investigators
- Gokhan Yildiz, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445386
- Sponsor's protocol ID
- Transdiscal vs Paravert SNB
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain
- ClinicalTrials.gov ID
- NCT07445386
- Acronym / sponsor ID
- Transdiscal vs Paravert SNB
- Conditions
- Cancer Pain
- Keywords
- Splanchnic Nerves, Nerve Block, Abdominal Pain, Pancreatic Neoplasms, Liver Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.
Detailed description
Cancer-related pain (CRP) is a complex and challenging condition to manage. Pain may be somatic, visceral, or neuropathic in origin, and more than 50% of patients present with a mixed pain pattern at the time of diagnosis. In addition to medical therapies such as opioids and adjuvant analgesics, various interventional procedures are used in the management of CRP. Among these, neurolytic nerve and plexus blocks represent effective options for patients with pain refractory to conservative treatment. Chemical neurolysis, as a minimally invasive neurolytic plexus block technique, provides effective analgesia by targeting both sensory afferent fibers and sympathetic fibers innervating visceral organs. Identifying the most appropriate block according to pain localization plays a crucial role in achieving successful pain control.
Splanchnic nerve neurolysis is an established interventional technique for the management of upper abdominal cancer pain associated with pancreatic, gastric, and hepatic malignancies. Both the paravertebral (PV) and transdiscal (TD) approaches have been shown to effectively reduce cancer-related abdominal pain and significantly improve quality of life in affected patients. However, comparative data between these two techniques remain limited.
The primary aim of this study is to compare the efficacy of paravertebral (PV) and transdiscal (TD) splanchnic nerve neurolysis in patients with severe upper abdominal cancer pain refractory to medical therapy, using the Numerical Rating Scale (NRS) for pain assessment. Secondary aims include evaluating the impact of these techniques on quality of life using the EORTC QLQ-C30 questionnaire, comparing changes in opioid consumption, comparing procedure duration and fluoroscopy imaging time, and determining the incidence of adverse events.
A total of 56 patients, 28 in each group, will be enrolled. Pain intensity will be assessed using the NRS before the procedure and at 3 days, 1 month, and 3 months after the intervention. Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire before the procedure and at 1 and 3 months post-intervention. Procedure-related adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transdiscal splanchnic neurolysis group | Active comparator | Procedure: transdiscal splanchnic neurolysisTransdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain |
| paravertebral splanchnic neurolysis group | Active comparator | Procedure: paravertebral splanchnic neurolysisParavertebral splanchnic neurolysis for upper gastrointestinal malignancy pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe abdominal pain (NRS > 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).
- Failure of pain control with conservative treatment modalities.
Key exclusion criteria (5 listed)
- Presence of local anatomical variations
- Localized or systemic infection involving the procedural site
- Pregnancy
- Coagulopathy
- Presence of unstable psychiatric disorders
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 |
|---|---|---|
| transdiscal splanchnic neurolysisWith the patient in the prone position, the T11-T12 vertebral levels were identified under anteroposterior fluoroscopic guidance, and the C-arm was adjusted to align the superior and inferior endplates of the T11-T12 intervertebral disc. The fluoroscope was then rotated obliquely to position the tip of the T12 superior articular process at the midpoint of the T11 vertebral body. After local anesthesia with 2 mL of 1% lidocaine, a spinal needle was advanced to the target point. The ideal final needle position was at the center of the intervertebral disc on the anteroposterior view and at the anterior border of the vertebral body on the lateral view. Correct needle placement was confirmed fluoroscopically, followed by injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 10 mL of 1% lidocaine resulting in >50% pain relief, 10 mL of 96% alcohol was slowly injected for neurolysis. | Procedure or surgery | transdiscal splanchnic neurolysis group |
| paravertebral splanchnic neurolysisUnder C-arm fluoroscopic guidance, the inferior border of the T11 vertebral body was used as a reference, and the fluoroscope was adjusted to a 15-20° craniocaudal and approximately 15-20° oblique angle. The needle entry point was selected slightly inferior to the T11 transverse process, and after local anesthesia with 2 mL of 1% lidocaine, the spinal needle was advanced along the lateral aspect of the vertebral body. On lateral fluoroscopic view, the needle tip was positioned at the anterior two-thirds of the vertebral body. Correct needle placement was confirmed fluoroscopically, followed by negative aspiration and injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 5 mL of 1% lidocaine resulting in >50% pain relief, 5 mL of 96% alcohol was slowly injected for neurolysis. The same procedure was repeated contralaterally, resulting in a total of 10 mL of 96% alcohol. | Procedure or surgery | paravertebral splanchnic neurolysis group |
Primary outcome
Numerical rating scale (NRS)
Time frame: Change from baseline to post-treatment day 3, and at 1 and 3 months.
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
2 secondary outcomes
EORTC QLQ-C30 questionnaire
Time frame: Change from baseline to 1st and 3rd month after treatment
Fluoroscopy imaging time
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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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.
Gokhan Yildiz principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transdiscal splanchnic neurolysis and paravertebral splanchnic neurolysis in people with Cancer Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gokhan Yildiz (5059272589 ext. TR, gkoyldz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: Change from baseline to post-treatment day 3, and at 1 and 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 3 Mar 2026.