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

Phase 4

Recruiting

• Conditions: Postoperative Ileus
• Interventions: Procedure: Vagus stimulation; Procedure: Sham stimulation; Drug: Placebo; Drug: Prucalopride

• Registration Number: NCT02425774
• Lead Sponsor: KU Leuven

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation + Placebo	Placebo	* no stimulation * 1 placebo tablet at two different timepoints before surgery
Vagus stimulation + placebo	Placebo	* Stimulation at the beginning and the end of the surgery * 1 placebo tablet at two different timepoints before surgery
Vagus stimulation + placebo	Vagus stimulation	* Stimulation at the beginning and the end of the surgery * 1 placebo tablet at two different timepoints before surgery
Sham stimulation + Placebo	Sham stimulation	* no stimulation * 1 placebo tablet at two different timepoints before surgery
Prucalopride + sham stimulation	Sham stimulation	* 1 prucalopride tablet at two different timepoints before surgery * no stimulation
Prucalopride + sham stimulation	Prucalopride	* 1 prucalopride tablet at two different timepoints before surgery * no stimulation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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)
Time to discharge from the hospital	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)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)	From the date of surgery until the date of discharge from the hospital (on average 14 days)

Trial Locations

Locations (1)

University hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium