CompletedPhase 4

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

Belgium31 participantsStarted 2014-07

Plain-language summary

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: 1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS) 2. to evaluate whether prucalopride leads to accelerated post-operative recovery

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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))

What they're measuring

Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood

Timeframe: From the date of surgery until the date of lab analysis (up to 6 months)

Trial details

NCT IDNCT02425774

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02-27

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