Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway

Study Overview
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Brief Summary
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Hypothesis: Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an anti-inflammatory effect. Aims: In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of prucalopride. The following aims are formulated: to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS) to evaluate whether prucalopride leads to accelerated post-operative recovery

Official Title
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Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Procedure: Vagus stimulation
* Procedure: Sham stimulation
* Drug: Prucalopride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham stimulation + Placebo<br>no stimulation 1 placebo tablet at two different timepoints before surgery | Procedure: Sham stimulation<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Vagus stimulation + placebo<br>Stimulation at the beginning and the end of the surgery 1 placebo tablet at two different timepoints before surgery | Procedure: Vagus stimulation<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Prucalopride + sham stimulation<br>1 prucalopride tablet at two different timepoints before surgery no stimulation | Procedure: Sham stimulation<br> <br> Drug: Prucalopride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood |  | From the date of surgery until the date of lab analysis (up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to tolerance of oral food intake |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to tolerance of oral food intake AND first defecation |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to first defecation |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Gastrointestinal symptoms (nausea, pain, vomiting, bloating) |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to discharge from the hospital |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus