NCT07445386

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 16, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 22, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

Splanchnic NervesNerve BlockAbdominal PainPancreatic NeoplasmsLiver Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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)

    Change from baseline to post-treatment day 3, and at 1 and 3 months.

Secondary Outcomes (2)

  • EORTC QLQ-C30 questionnaire

    Change from baseline to 1st and 3rd month after treatment

  • Fluoroscopy imaging time

    During procedure

Study Arms (2)

transdiscal splanchnic neurolysis group

ACTIVE COMPARATOR

Transdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain

Procedure: transdiscal splanchnic neurolysis

paravertebral splanchnic neurolysis group

ACTIVE COMPARATOR

Paravertebral splanchnic neurolysis for upper gastrointestinal malignancy pain

Procedure: paravertebral splanchnic neurolysis

Interventions

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.

transdiscal splanchnic neurolysis group

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.

paravertebral splanchnic neurolysis group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of local anatomical variations
  • Localized or systemic infection involving the procedural site
  • Pregnancy
  • Coagulopathy
  • Presence of unstable psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cancer PainAbdominal PainPancreatic NeoplasmsLiver Neoplasms

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesLiver Diseases

Study Officials

  • Gokhan Yildiz

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gokhan Yildiz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor Investigator

Study Record Dates

First Submitted

February 22, 2026

First Posted

March 3, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

August 16, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations