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Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer

NCT07733427 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-31

No results posted yet for this study

Summary

The aim of this clinical trial is to assess the effectiveness of intratracheal analgesia on pain intensity in cancer patients, from the start of treatment up to 3 months. It will also investigate the safety of this technique. The main questions it seeks to answer are as follows:

What is the impact on the use of opioid analgesics, and can this be measured? What is the quality of life? What is the quality of sleep, and can this be assessed? How does the patient's weight change? Is the patient satisfied? What is the patient's overall survival?

The researchers will assess the equivalent daily dose of morphine (mg/day) between enrolment and follow-up visits, as well as the number of patients requiring an escalation of analgesic treatment. Overall quality of life score measured using the ESAS questionnaire between enrolment and follow-up visits; satisfaction assessed using a numerical satisfaction scale (0-10); sleep quality assessed using the ISI questionnaire; and the tolerability and safety of the technique assessed by monitoring adverse events.

Eligible participants:

Following implantation of the intrathecal pump, participants will have scheduled consultations at day 30, then at 3, 6, 9 and 12 months, with questionnaires to be completed.

Conditions

  • Pancreatic Cancer Pain
  • Intrathecal Analgesic
  • Intrathecal Administration of the Drug
  • Pancreatic Carcinoma

Interventions

DEVICE

Intrathecal catheter connected to an implantable pump

Epidural puncture (AL injection), followed by a lumbar puncture and collection of cerebrospinal fluid. Positioning of the catheter behind the spinal cord at the desired metameric level for the pancreas (T5-T7), and positioning of the pump in the flank or buttock.

DRUG

Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections

Medications are administered via an intrathecal catheter connected to an implantable pump or via periodic injections; the patient is admitted to hospital with morphine (IV, PO, transdermal) discontinued on entry to the unit (the same applies to methadone). Depending on the condition of the patient's abdominal skin (stoma, multiple injections, etc.) and any foreseeable technical difficulties during MRI scanning (in the left or right lateral positions), the procedure is performed under fluoroscopy, with appropriate antibiotic prophylaxis, under local anaesthesia, epidural anaesthesia and light sedation. Product used, dosage and frequency: Opioids: μ and δ receptors: Morphine sulphate: 50 mg/ml Ca++ channels: ziconotide: initial dose 0.5 µg/day Sodium channels: 1% ropivacaine As with a patient-controlled analgesia (PCA) system: Continuous infusion + bolus or sequential boluses Patient education on the use of the pump during their hospital stay.

Sponsors & Collaborators

  • Clinique Bizet

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733427 on ClinicalTrials.gov