2023-503349-71-00
Recruiting
Phase 2
TransNiDeG - The Effect of Transcutaneous Nicotine Administration on the Development of Delayed Gastric Emptying following Pancreatoduodenectomy - a randomized, placebo-controlled, double-blind, multicenter trial
Rheinische Friedrich Wilhelms Universitaet Bonn7 sites in 1 country240 target enrollmentStarted: August 7, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Rheinische Friedrich Wilhelms Universitaet Bonn
- Enrollment
- 240
- Locations
- 7
- Primary Endpoint
- Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
Overview
Brief Summary
To assess the effect of transcutaneous administration of nicotine as compared to placebo on the development and severity of delayed gastric emptying (DGE) following pancreatoduodenectomy
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subject aged ≥ 18 years
- •given written informed consent to participate in the trial
- •planned for pancreatoduodenectomy
- •smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)
Exclusion Criteria
- •Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- •Immediately after heart attack
- •Severe cardiac arrhythmia
- •Stroke that occurred shortly before
- •Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial
- •Current or planned pregnancy or nursing women
- •Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep-tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •Distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guidelines)
- •former gastrectomy
- •liver fibrosis/cirrhosis
Outcomes
Primary Outcomes
Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
Secondary Outcomes
- postoperative pancreatic fistula
- postpancreatectomy hemorrhage
- intraabdominal fluid collections
- surgical site infections
- re-intervention rate
- re-operation rate
- Clavien-Dindo classification
- MTL30 score
- quality-of-life questionnaires (QLQ-C30 and PAN26)
- mortality
- cardiovascular events ((non-fatal) myocardial infarction, (non-fatal) stroke, revascularization during admission)
- requirement of naso-gastric tube (NGT) in the first 21 days after surgery
- inability to tolerate solid oral food in the first 21 days after surgery
- vomiting/gastric distension in the first 21 days after surgery
- use of prokinetics in the first 21 days after surgery
- Adverse Events and Serious Adverse Events
Investigators
PD Dr. Tim Glowka
Scientific
Rheinische Friedrich Wilhelms Universitaet Bonn
Study Sites (7)
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