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

Catholic University (KU) of Leuven

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Ileus

Treatments: Procedure: Vagus stimulation; Drug: Placebo; Drug: Prucalopride; Procedure: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02425774

S56328

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Sham stimulation + Placebo

Placebo Comparator group

Description:

* no stimulation * 1 placebo tablet at two different timepoints before surgery

Treatment:

Drug: Placebo

Procedure: Sham stimulation

Vagus stimulation + placebo

Active Comparator group

Description:

* Stimulation at the beginning and the end of the surgery * 1 placebo tablet at two different timepoints before surgery

Treatment:

Procedure: Vagus stimulation

Drug: Placebo

Prucalopride + sham stimulation

Active Comparator group

Description:

* 1 prucalopride tablet at two different timepoints before surgery * no stimulation

Treatment:

Drug: Prucalopride

Procedure: Sham stimulation