Using prucalopride to reduce inflammation before surgery
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus
This study is testing if a medication called prucalopride can help reduce inflammation and speed up recovery for people having surgery for pancreatic tumors, similar to what electrical stimulation of the vagus nerve does.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT02425774 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the anti-inflammatory effects of prucalopride, a medication that may mimic the effects of electrical stimulation of the abdominal vagus nerve. The study aims to demonstrate that prucalopride can produce similar anti-inflammatory outcomes as vagus nerve stimulation and to assess its potential to accelerate recovery after surgery. Participants will receive either prucalopride, vagus nerve stimulation, sham stimulation, or a placebo to evaluate the treatment's effectiveness. The focus is on patients undergoing pancreatic surgery for tumors.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for partial or full resection of the pancreas due to benign or malignant tumors.
Not a fit: Patients with chronic pancreatitis, significant intra-abdominal inflammation, or poorly regulated diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced inflammation for patients undergoing pancreatic surgery.
How similar studies have performed: While the specific use of prucalopride in this context is novel, similar approaches using vagus nerve stimulation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor Exclusion Criteria: * adjuvant radiotherapy * evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory results, including an abscess or cholecystitis) * chronic pancreatitis * pancreatic polypeptide producing endocrine tumor * American Society of Anesthesiologists physical-health status classification (ASA-PS)\>3 * Poorly regulated diabetes (\>200 mg/dl (=11 mmol/l))
Where this trial is running
Leuven, Vlaams-Brabant
- University hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Guy Boeckxstaens, M.D. — Catholic University Leuven
- Study coordinator: Nathalie Stakenborg, MSc
- Email: nathalie.stakenborg@med.kuleuven.be
- Phone: +32 16 342883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.