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

February 7, 2023 updated by: Guy Boeckxstaens, KU Leuven

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Sham stimulation + Placebo
  • no stimulation
  • 1 placebo tablet at two different timepoints before surgery
Drug: Placebo
Procedure: Sham stimulation
ACTIVE_COMPARATOR: Vagus stimulation + placebo
  • Stimulation at the beginning and the end of the surgery
  • 1 placebo tablet at two different timepoints before surgery
Drug: Placebo
Procedure: Vagus stimulation
ACTIVE_COMPARATOR: Prucalopride + sham stimulation
  • 1 prucalopride tablet at two different timepoints before surgery
  • no stimulation
Procedure: Sham stimulation
Drug: Prucalopride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From the date of surgery until the date of lab analysis (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first flatus
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
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)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
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)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
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)
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
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (ESTIMATE)

April 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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