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Pancreatic Cancer PainPITNCT07733427

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

A study testing Intrathecal catheter connected to an implantable pump and Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections in people with Pancreatic Cancer Pain and Intrathecal Analgesic, run by Clinique Bizet at 3 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Intrathecal catheter connected to an implantable pump and Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesFrance
Study dates
Sep 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject aged over 20 years
  • Patient with histologically confirmed pancreatic carcinoma
  • Chronic cancer-related pain that is inadequately controlled by standard treatment or for whom analgesics are contraindicated.
  • EMO < 120 mg/day Patients experiencing side effects: sedation, vomiting, constipation, or an allergy to morphine.
  • Signed informed consent
  • Participants affiliated with or eligible for a social security scheme
  • Agree to complete the various study questionnaires

Who cannot join

  • Patients under the age of 20.
  • Contraindications to intratracheal analgesia
  • Acute respiratory infection
  • Uncontrolled coagulation disorder
  • Pregnancy or breastfeeding
  • Unable to comply with medical follow-up for the study.
  • Adults who are legally protected, under guardianship or under a conservatorship

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bouchra BENKESSOU Chef de projet Recherche Clinique contact

+33 7 64 48 60 16

b.benkessou@hexagone-sante-paris.fr

France3 sites

  • Benkessou

    Paris, 75016

  • Bizet Clinic

    Paris, 75016

  • Clinique Bizet

    Paris, 75016

Other trials in France

About this study

Official title: A Pilot Study Aimed at Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer

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?

Read more

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.

Being tested
Intrathecal catheter connected to an implantable pump, Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal catheter connected to an implantable pumpDevice

    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.

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

    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.

Study groups in NCT07733427
Study groupRoleWhat they receive
Intrathecal catheter implantable pumpExperimentalAdministration of the medicine via an intrathecal catheter connected to an implantable pump
Receives: Device: Intrathecal catheter connected to an implantable pump; Drug: Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore

    Change in pain intensity score measured by the ESAS subscale from baseline to follow-up visits.

    Unit of Measure: Score on a scale (0 to 10) Scale Range (Minimum and Maximum Values): 0 to 10

    Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

Secondary outcomes (8)

  1. Change in Edmonton Symptom Assessment System (ESAS) Overall Quality of Life Score

    Change in overall score as measured by the Edmonton Symptom Assessment System (ESAS) from baseline to follow-up visits.

    Unit of Measure: Score on a scale (ESAS Score) Scale Range (Minimum and Maximum Values): 0 to 10

    Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  2. Proportion of Patients Requiring Pain Treatment Escalation

    Number of patients requiring an increase or escalation in pain management treatment during follow-up.

    Unit of Measure: Number of participants (or Percentage)

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  3. Change in Daily Morphine Equivalent Dose (MED)

    Change in daily opioid dose from baseline to follow-up visits.

    Unit of Measure: mg/day

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  4. Change in Sleep Quality Score Insomnia Severity Index (ISI)

    Change in insomnia severity measured by the Insomnia Severity Index (ISI) questionnaire from baseline to follow-up visits.

    Scale Range (Minimum and Maximum Values): 0 to 28 (Derived from summing the 7 individual items, each scored on a 0 to 4 scale evaluating sleep onset, maintenance, early morning awakening, satisfaction, daytime interference, noticeability, and distress)

    Direction of Scores: Higher score 4 means a worse outcome (greater insomnia severity and impaired quality of life)

    Unit of Measure: Score on a scale (ISI Score)

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  5. Change in Body Weight

    Change in body weight from baseline to follow-up visits.

    Unit of Measure: Kilograms (kg)

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  6. Patient Satisfaction Clinical Global Impressions Scale (typically either CGI-Severity or CGI-Improvement)

    Overall patient satisfaction Clinical Global Impressions (typically either CGI-Severity or CGI-Improvement) rated on a numerical scale.

    Unit of Measure: Score on a scale

    Scale Range (Minimum and Maximum Values): 1 to 7

    Direction of Scores: Higher scores mean a worse outcome (e.g., greater illness severity or worsening condition).

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  7. Incidence of Adverse Events Related to Intratracheal Analgesia

    Number of participants experiencing at least one adverse event related to the intratracheal analgesia technique.

    Unit of Measure: Number of participants

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

  8. Incidence of Serious Adverse Events (SAEs)

    Number of participants experiencing a serious adverse event during the study period.

    Unit of Measure: Number of participants

    Measured: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733427
Sponsor's protocol ID
2026-A00905-46
Acronym
PIT
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park J, Park EY, Han SS, Park HM, Lee M, Lee SA, Kim SW, Kim DH, Park SJ. Randomized controlled study comparing the analgesic effects of intravenous patient-controlled analgesia and patient-controlled epidural analgesia after open major surgery for pancreatobiliary cancer. HPB (Oxford). 2022 Aug;24(8):1238-1244. doi: 10.1016/j.hpb.2022.01.013. Epub 2022 Feb 3.

    PubMed 35183448

  • Bruel BM, Burton AW. Intrathecal Therapy for Cancer-Related Pain. Pain Med. 2016 Dec;17(12):2404-2421. doi: 10.1093/pm/pnw060. Epub 2016 Apr 28.

    PubMed 28025375

  • Cohen SP, Dragovich A. Intrathecal analgesia. Anesthesiol Clin. 2007 Dec;25(4):863-82, viii. doi: 10.1016/j.anclin.2007.07.001.

    PubMed 18054150

  • Smith HS, Deer TR, Staats PS, Singh V, Sehgal N, Cordner H. Intrathecal drug delivery. Pain Physician. 2008 Mar;11(2 Suppl):S89-S104.

    PubMed 18443642

  • Rizvi S, Kumar K. History and present state of targeted intrathecal drug delivery. Curr Pain Headache Rep. 2015;19(2):474. doi: 10.1007/s11916-014-0474-8.

    PubMed 25638694

  • Kroenke K, Theobald D, Wu J, Loza JK, Carpenter JS, Tu W. L'association de la dépression et de la douleur avec la qualité de vie liée à la santé, le handicap et l'utilisation des soins de santé chez les patients atteints de cancer. J gestion des symptômes de douleur. 2010; 40(3):327-41. [DOI] [Article gratuit PMC] [PubMed] [Google Scholar][Liste des références]

  • -Roberto A, Greco MT, Uggeri S, Cavuto S, Deandrea S, Corli O, et al. Revue systématique vivante pour évaluer le sous-traitement analgésique chez les patients atteints de cancer. Pratique de la douleur. 2022; 22(4):487-96. [DOI] [PubMed] [Google Scholar][Liste de références]

  • Haan S, Kortylewski M, Behrmann I, Muller-Esterl W, Heinrich PC, Schaper F. Cytoplasmic STAT proteins associate prior to activation. Biochem J. 2000 Feb 1;345 Pt 3(Pt 3):417-21.

    PubMed 10642496

  • Carvajal G, Dupoiron D, Seegers V, Lebrec N, Bore F, Dubois PY, Leblanc D, Delorme T, Jubier-Hamon S. Intrathecal Drug Delivery Systems for Refractory Pancreatic Cancer Pain: Observational Follow-up Study Over an 11-Year Period in a Comprehensive Cancer Center. Anesth Analg. 2018 Jun;126(6):2038-2046. doi: 10.1213/ANE.0000000000002903.

    PubMed 29543644

  • Bruera E, Kim HN. Cancer pain. JAMA. 2003 Nov 12;290(18):2476-9. doi: 10.1001/jama.290.18.2476. No abstract available.

    PubMed 14612485

  • Caraceni A, Portenoy RK; a working group of the IASP Task Force on Cancer Pain. An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain. Pain. 1999 Sep;82(3):263-274. doi: 10.1016/S0304-3959(99)00073-1.

    PubMed 10488677

Questions about this trial

What is this clinical trial studying?

A study testing Intrathecal catheter connected to an implantable pump and Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections in people with Pancreatic Cancer Pain and Intrathecal Analgesic, run by Clinique Bizet at 3 sites in France.

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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bouchra BENKESSOU Chef de projet Recherche Clinique (+33 7 64 48 60 16, b.benkessou@hexagone-sante-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore (time frame: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months). 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 NCT07733427, which also lists 11 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 10 Sep 2026.

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