Upper Abdominal MalignanciesNCT07761650
Comparison of CT-Guided Celiac Plexus Neurolysis and Pharmacotherapy
A study testing CT-guided celiac plexus neurolysis and Standard pharmacotherapy in people with Upper Abdominal Malignancies and Upper Gastrointestinal Cancer, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
After enrolment, patients were randomly assigned to two groups by means of a lottery procedure, whereby each patient blindly chose one of two labelled slips, resulting in group assignment to receive. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Abdominal Malignancies, Upper Gastrointestinal Cancer
- What is being tested?
- CT-guided celiac plexus neurolysis and Standard pharmacotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Nov 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven upper GI malignancy with severe abdominal pain
- Patients aged 18 to 65 years of either gender
Who cannot join
- Pregnant and lactating females
- Anemia (hemoglobin <10 g/dL)
- Massive ascites
- Chronic renal failure
- Patients with known allergy or intolerance to drugs used during celiac plexus neurolysis (CT guided technique).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Effects of CT-Guided Celiac Plexus Neurolysis With Pharmacotherapy as Palliative Care of Upper Gastrointestinal Malignancies
After enrolment, patients were randomly assigned to two groups by means of a lottery procedure, whereby each patient blindly chose one of two labelled slips, resulting in group assignment to receive. Group A patients were subjected to CT-guided celiac plexus neurolysis, and Group B patients to standard pharmacotherapy for managing the pain over a period of four weeks.
CT-guided celiac plexus neurolysis under the supervision of the principal investigator, using local anaesthetic and absolute ethanol injection for neurolysis, was carried out using aseptic technique. Baseline demographic information, which included age, gender, nature of malignancy, and the duration of disease, was recorded using a predesigned proforma. Pain severity was measured by the Visual Analogue Scale (VAS), a recognised 0-10 scale where 0 = no pain to 10 indicating the worst imaginable pain, at baseline and after 4 weeks of treatment. The major outcome measure was the average pain score at four weeks in both groups.
- Being tested
- CT-guided celiac plexus neurolysis, Standard pharmacotherapy
- Keywords
- Upper Gastrointestinal Malignancies, Celiac Plexus Neurolysis, Pharmacotherapy, Palliative Care, Visual Analogue Scale, Pain Management
- Medical subject headings
- Gastrointestinal Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided celiac plexus neurolysisProcedure or surgery
Under intermittent CT guidance, one or two 20-22-gauge Chiba needles are advanced via a posterior paravertebral approach to the anterolateral aspect of the aorta at the level of the celiac axis. Correct needle placement is confirmed by CT imaging and the injection of a small amount of nonionic contrast material to ensure appropriate spread and exclude intravascular or intrathecal positioning. Following negative aspiration for blood or cerebrospinal fluid, a test dose of local anesthetic (commonly 5-10 mL of 1% lidocaine) is administered to minimize procedural pain and assess for adverse effects. Subsequently, a neurolytic agent, typically 15-25 mL of 95-100% absolute alcohol or 6-10% phenol on each side depending on the technique used, is slowly injected under CT guidance to achieve circumferential spread around the celiac plexus. A final CT scan is obtained to document the distribution of the neurolytic solution and exclude immediate complications.
Standard pharmacotherapyProcedure or surgery
Patients will be provided with the standard oral and intravenous analgesics such as fentanyl and oxycodone.
| Study group | Role | What they receive |
|---|---|---|
| CT-guided celiac plexus neurolysis | Experimental | Not described Receives: Procedure: CT-guided celiac plexus neurolysis |
| Standard pharmacotherapy | Active comparator | Not described Receives: Procedure: Standard pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain score at baseline and after 4 weeks of treatment
Pain severity was measured by the Visual Analogue Scale (VAS), a recognized 0-10 scale where zero is equivalent to no pain and 10 indicates the worst imaginable pain, at baseline and after 4 weeks of treatment.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 May 2025
- Primary completion30 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Abdominal MalignanciesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Usama Sardar, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761650
- Sponsor's protocol ID
- 184/RC/KEMU
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An excel sheet comprising of the patient details and outputs will be shared.
Publications
Daniels M, Duran E, Pan V, Rentzepis P, An T, Thabet A, Hao D. Computed Tomography-Guided Celiac Plexus Block and Neurolysis: Technical Outcomes and Complications. Pain Physician. 2026 Jan;29(1):E59-E66.
PubMed 41628217Faghih M, Damm M, Bandhauer C, Jager J, Olesen SS, Laheru DA, Zheng L, Phillips AE, Yadav D, Drewes AM, Rosendahl J, Singh VK. Pancreatic adenocarcinoma patients with pain have abnormal central pain processing. Pancreatology. 2025 May;25(3):426-432. doi: 10.1016/j.pan.2025.04.010. Epub 2025 Apr 16.
PubMed 40382254
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effects of CT-Guided Celiac Plexus Neurolysis With Pharmacotherapy as Palliative Care of Upper Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT07761650
- Acronym / sponsor ID
- 184/RC/KEMU
- Keywords
- Upper Gastrointestinal Malignancies, Celiac Plexus Neurolysis, Pharmacotherapy, Palliative Care, Visual Analogue Scale, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Aug 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.
After enrolment, patients were randomly assigned to two groups by means of a lottery procedure, whereby each patient blindly chose one of two labelled slips, resulting in group assignment to receive. Group A patients were subjected to CT-guided celiac plexus neurolysis, and Group B patients to standard pharmacotherapy for managing the pain over a period of four weeks.
CT-guided celiac plexus neurolysis under the supervision of the principal investigator, using local anaesthetic and absolute ethanol injection for neurolysis, was carried out using aseptic technique. Baseline demographic information, which included age, gender, nature of malignancy, and the duration of disease, was recorded using a predesigned proforma. Pain severity was measured by the Visual Analogue Scale (VAS), a recognised 0-10 scale where 0 = no pain to 10 indicating the worst imaginable pain, at baseline and after 4 weeks of treatment. The major outcome measure was the average pain score at four weeks in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided celiac plexus neurolysis | Experimental | Procedure: CT-guided celiac plexus neurolysis |
| Standard pharmacotherapy | Active comparator | Procedure: Standard pharmacotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy proven upper GI malignancy with severe abdominal pain
- Patients aged 18 to 65 years of either gender
Key exclusion criteria (5 listed)
- Pregnant and lactating females
- Anemia (hemoglobin <10 g/dL)
- Massive ascites
- Chronic renal failure
- Patients with known allergy or intolerance to drugs used during celiac plexus neurolysis (CT guided technique).
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 |
|---|---|---|
| CT-guided celiac plexus neurolysisUnder intermittent CT guidance, one or two 20-22-gauge Chiba needles are advanced via a posterior paravertebral approach to the anterolateral aspect of the aorta at the level of the celiac axis. Correct needle placement is confirmed by CT imaging and the injection of a small amount of nonionic contrast material to ensure appropriate spread and exclude intravascular or intrathecal positioning. Following negative aspiration for blood or cerebrospinal fluid, a test dose of local anesthetic (commonly 5-10 mL of 1% lidocaine) is administered to minimize procedural pain and assess for adverse effects. Subsequently, a neurolytic agent, typically 15-25 mL of 95-100% absolute alcohol or 6-10% phenol on each side depending on the technique used, is slowly injected under CT guidance to achieve circumferential spread around the celiac plexus. A final CT scan is obtained to document the distribution of the neurolytic solution and exclude immediate complications. | Procedure or surgery | CT-guided celiac plexus neurolysis |
| Standard pharmacotherapyPatients will be provided with the standard oral and intravenous analgesics such as fentanyl and oxycodone. | Procedure or surgery | Standard pharmacotherapy |
Primary outcome
Average pain score at baseline and after 4 weeks of treatment
Time frame: Baseline to 4 weeks
Pain severity was measured by the Visual Analogue Scale (VAS), a recognized 0-10 scale where zero is equivalent to no pain and 10 indicates the worst imaginable pain, at baseline and after 4 weeks of treatment.
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 12 Aug 2026.
- Background: PubMed 41628217Daniels M, Duran E, Pan V, Rentzepis P, An T, Thabet A, Hao D. Computed Tomography-Guided Celiac Plexus Block and Neurolysis: Technical Outcomes and Complications. Pain Physician. 2026 Jan;29(1):E59-E66.
- Background: PubMed 40382254Faghih M, Damm M, Bandhauer C, Jager J, Olesen SS, Laheru DA, Zheng L, Phillips AE, Yadav D, Drewes AM, Rosendahl J, Singh VK. Pancreatic adenocarcinoma patients with pain have abnormal central pain processing. Pancreatology. 2025 May;25(3):426-432. doi: 10.1016/j.pan.2025.04.010. Epub 2025 Apr 16.
- Individual participant dataSharing planned: Yes. An excel sheet comprising of the patient details and outputs will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided celiac plexus neurolysis and Standard pharmacotherapy in people with Upper Abdominal Malignancies and Upper Gastrointestinal Cancer, run by Mayo Hospital Lahore at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 12 Aug 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 Pakistan. 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?
Average pain score at baseline and after 4 weeks of treatment (time frame: Baseline to 4 weeks). 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 NCT07761650, which also lists 2 linked publications.
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 12 Aug 2026.