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Completed

NCT Number: NCT02425774

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

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

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Vagus stimulation

Procedure

Sham stimulation

Procedure

prucalopride

Drug

Placebo

Drug

Primary outcomes

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

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

Secondary outcomes

  1. Time to first flatus

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  2. Time to tolerance of oral food intake

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  3. Time to tolerance of oral food intake AND first defecation

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  4. Time to first defecation

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  5. Gastrointestinal symptoms (nausea, pain, vomiting, bloating)

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  6. Time to discharge from the hospital

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2015
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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