Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
Study Details
Study Description
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:
-
to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
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to evaluate whether prucalopride leads to accelerated post-operative recovery
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Sham stimulation + Placebo no stimulation 1 placebo tablet at two different timepoints before surgery |
Procedure: Sham stimulation
Drug: Placebo
|
| Active Comparator: Vagus stimulation + placebo Stimulation at the beginning and the end of the surgery 1 placebo tablet at two different timepoints before surgery |
Procedure: Vagus stimulation
Drug: Placebo
|
| Active Comparator: Prucalopride + sham stimulation 1 prucalopride tablet at two different timepoints before surgery no stimulation |
Procedure: Sham stimulation
Drug: Prucalopride
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [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)]
- Gastrointestinal symptoms (nausea, pain, vomiting, bloating) [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)]
Eligibility Criteria
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)
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chronic pancreatitis
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pancreatic polypeptide producing endocrine tumor
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American Society of Anesthesiologists physical-health status classification (ASA-PS)>3
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Poorly regulated diabetes (>200 mg/dl (=11 mmol/l))
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospitals Leuven | Leuven | Vlaams-Brabant | Belgium | 3000 |
Sponsors and Collaborators
- KU Leuven
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Guy Boeckxstaens, M.D., Catholic University Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
- Kalff JC, Buchholz BM, Eskandari MK, Hierholzer C, Schraut WH, Simmons RL, Bauer AJ. Biphasic response to gut manipulation and temporal correlation of cellular infiltrates and muscle dysfunction in rat. Surgery. 1999 Sep;126(3):498-509.
- Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63.
- S56328