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

Last updated: March 19, 2026
Sponsor: KU Leuven
Overall Status: Completed

Phase

4

Condition

Ileus

Treatment

Prucalopride

Placebo

Sham stimulation

Clinical Study ID

NCT02425774
S56328
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients undergoing partial or full resection of the pancreas due to a benign ormalignant tumor

Exclusion

Exclusion Criteria:

  • adjuvant radiotherapy

  • evident intra-abdominal inflammation (diagnosed by imaging and/or laboratoryresults, 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))

Study Design

Total Participants: 31
Treatment Group(s): 4
Primary Treatment: Prucalopride
Phase: 4
Study Start date:
July 01, 2014
Estimated Completion Date:
February 27, 2016

Connect with a study center

  • University hospitals Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

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