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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02425774
• Other study ID #: S56328
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: KU Leuven
• Contact: Nathalie Stakenborg, MSc
• Phone: +32 16 342883
• Email: nathalie.stakenborg[@]med.kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Vagus stimulation

• Sham stimulation

Drug:
• Prucalopride

• Placebo

Locations

Country	Name	City	State
Belgium	University hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. doi: 10.1097/00000658-199811000-00004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first flatus		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to tolerance of oral food intake		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	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)
Secondary	Time to first defecation		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Gastrointestinal symptoms (nausea, pain, vomiting, bloating)		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to discharge from the hospital		From the date of surgery until the date of discharge from the hospital (on average 14 days)