NCT07761650

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 2, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Upper Gastrointestinal MalignanciesCeliac Plexus NeurolysisPharmacotherapyPalliative CareVisual Analogue ScalePain Management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 4 weeks

Study Arms (2)

CT-guided celiac plexus neurolysis

EXPERIMENTAL
Procedure: CT-guided celiac plexus neurolysis

Standard pharmacotherapy

ACTIVE COMPARATOR
Procedure: Standard pharmacotherapy

Interventions

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.

CT-guided celiac plexus neurolysis

Patients will be provided with the standard oral and intravenous analgesics such as fentanyl and oxycodone.

Standard pharmacotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven upper GI malignancy with severe abdominal pain
  • Patients aged 18 to 65 years of either gender

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 41628217BACKGROUND
  • Faghih 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.

    PMID: 40382254BACKGROUND

MeSH Terms

Conditions

Gastrointestinal NeoplasmsAgnosia

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 12, 2026

Study Start

May 1, 2025

Primary Completion

August 30, 2025

Study Completion

November 30, 2025

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

An excel sheet comprising of the patient details and outputs will be shared.

Locations