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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Katholieke Universiteit Leuven; KU Leuven
• Collaborator: Universitaire Ziekenhuizen Leuven
• Treatments: Anti-Inflammatory Agents; Cholinergic Agents; Prucalopride

Criteria

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))