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

Primary Purpose

Postoperative Ileus

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Vagus stimulation
Sham stimulation
Prucalopride
Placebo
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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))

Sites / Locations

  • University hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Sham stimulation + Placebo

Vagus stimulation + placebo

Prucalopride + sham stimulation

Arm Description

no stimulation 1 placebo tablet at two different timepoints before surgery

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

1 prucalopride tablet at two different timepoints before surgery no stimulation

Outcomes

Primary Outcome Measures

Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood

Secondary Outcome Measures

Time to first flatus
Time to tolerance of oral food intake
Time to tolerance of oral food intake AND first defecation
Time to first defecation
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time to discharge from the hospital

Full Information

First Posted
February 24, 2015
Last Updated
February 7, 2023
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02425774
Brief Title
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
Official Title
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. 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) to evaluate whether prucalopride leads to accelerated post-operative recovery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham stimulation + Placebo
Arm Type
Placebo Comparator
Arm Description
no stimulation 1 placebo tablet at two different timepoints before surgery
Arm Title
Vagus stimulation + placebo
Arm Type
Active Comparator
Arm Description
Stimulation at the beginning and the end of the surgery 1 placebo tablet at two different timepoints before surgery
Arm Title
Prucalopride + sham stimulation
Arm Type
Active Comparator
Arm Description
1 prucalopride tablet at two different timepoints before surgery no stimulation
Intervention Type
Procedure
Intervention Name(s)
Vagus stimulation
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation
Intervention Type
Drug
Intervention Name(s)
Prucalopride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Time Frame
From the date of surgery until the date of lab analysis (up to 6 months)
Secondary Outcome Measure Information:
Title
Time to first flatus
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to tolerance of oral food intake
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to tolerance of oral food intake AND first defecation
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to first defecation
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to discharge from the hospital
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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))
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Stakenborg, MSc
Phone
+32 16 342883
Email
nathalie.stakenborg@med.kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Van Beek, MSc
Phone
+32 16 341326
Email
kim.vanbeek@med.kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, M.D.
Organizational Affiliation
Catholic University Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Stakenborg, MSc
Phone
+32 16 342883
Email
nathalie.stakenborg@med.kuleuven.be
First Name & Middle Initial & Last Name & Degree
Koen Bellens, MSc
Phone
+32 16 341943
Email
koen.bellens@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
10486602
Citation
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.
Results Reference
background
PubMed Identifier
9833803
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.
Results Reference
background
PubMed Identifier
30472681
Citation
Stakenborg N, Labeeuw E, Gomez-Pinilla PJ, De Schepper S, Aerts R, Goverse G, Farro G, Appeltans I, Meroni E, Stakenborg M, Viola MF, Gonzalez-Dominguez E, Bosmans G, Alpizar YA, Wolthuis A, D'Hoore A, Van Beek K, Verheijden S, Verhaegen M, Derua R, Waelkens E, Moretti M, Gotti C, Augustijns P, Talavera K, Vanden Berghe P, Matteoli G, Boeckxstaens GE. Preoperative administration of the 5-HT4 receptor agonist prucalopride reduces intestinal inflammation and shortens postoperative ileus via cholinergic enteric neurons. Gut. 2019 Aug;68(8):1406-1416. doi: 10.1136/gutjnl-2018-317263. Epub 2018 Nov 24.
Results Reference
derived

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

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