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NCT Number: NCT07825870

Outcomes of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain.

The goal of this prospective study is to learn whether fluoroscopy-guided transdiscal splanchnic nerve neurolysis can safely reduce severe upper abdominal cancer pain in adults with pancreatic, gastric, or hepatobiliary cancer. The study will also assess whether this procedure can reduce the need for opioid pain medicines and improve patients' functional status and quality of life.

The main questions it aims to answer are:

Does the procedure reduce patients' pain one month after treatment?

Does it reduce the amount of opioid pain medication patients need?

Does it improve functional status and quality of life?

What complications or side effects occur after the procedure?

How long does pain relief last, and how often is repeat treatment needed?

Participants will:

First receive a diagnostic splanchnic nerve block with local anesthetic.

If the diagnostic block provides at least 50% pain relief, undergo transdiscal splanchnic nerve neurolysis using fluoroscopy guidance.

Receive a neurolytic agent (absolute alcohol or phenol) through a needle placed at the T11-T12 or T12-L1 level.

Have their pain, opioid medication use, functional status, complications, and satisfaction assessed before treatment and during follow-up.

Complete follow-up assessments at 1 week, 1 month, 3 months, and 6 months after the procedure.

Complete a quality-of-life questionnaire before treatment and at 1 month.

The primary outcome will be the change in pain score on the 0-10 Numeric Rating Scale at 1 month after the procedure.

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Key information

Conditions

Upper Abdominal Cancer Pain Cancer Pain Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatobiliary Cancer Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years. Confirmed diagnosis of pancreatic, gastric, or hepatobiliary malignancy with epigastric/upper abdominal pain.

Baseline NRS ≥ 7 despite optimized pharmacotherapy, or intolerable opioid side effects.

≥ 50% pain relief on diagnostic splanchnic nerve block. Able to provide informed consent.

Exclusion criteria

  • Coagulopathy (INR > 1.5, platelets < 50,000/µL). Local or systemic infection. Uncontrolled hypotension or severe cardiopulmonary compromise precluding prone positioning.

Intestinal obstruction. Known allergy to contrast, local anesthetic, or the neurolytic agent. Patient refusal.

Treatment and study plan

Chemical Neurolysis

Procedure

Chemical neurolysis will be performed using the study-specified neurolytic agent (alcohol or phenol) to provide pain relief in patients with chronic pain. The procedure will be performed under appropriate clinical and imaging guidance according to the study protocol. Participants will be followed prospectively to assess pain relief, duration of analgesia, functional outcomes, and procedure-related adverse events

Primary outcomes

  1. Change in pain intensity

    Time frame: Baseline to 1 month after the procedure

    Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The change in NRS pain score from baseline will be assessed following fluoroscopy-guided transdiscal splanchnic nerve neurolysis.

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.

  2. Technical success of neurolysis

    Time frame: During the procedure

    Successful completion of fluoroscopy-guided transdiscal splanchnic nerve neurolysis as intended according to the study protocol.

  3. Opioid consumption

    Time frame: Baseline, 1 week, 1 month,

    Change in daily opioid consumption expressed as oral morphine milligram equivalents (MME) compared with baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Shahid, MBBS, FCPS

CONTACT

[email protected]

923336173056

Umer Hussain, MBBS

CONTACT

[email protected]

923116467002

Sponsors and collaborators

Lead sponsor

Sahiwal medical college sahiwal

Other Gov

Registry information

Official study title

Clinical Outcomes and Safety of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis in Patients With Upper Abdominal Cancer Pain: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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