To assess the effect of transcutaneous administration of nicotine as compared to placebo on the development and severity of delayed gastric emptying (DEG) following pancreatoduodenectomy

To evaluate the safety and tolerability of transcuta-neous nicotine administration as compared to pla-cebo in patients requiring pancreatoduodenectomy

Male and female patients with benign and malignant lesions of the periampul-lary region (e.g. pancreatic carcinoma, distal bile duct carcinoma, duodenal carci-noma, ampullary carcinoma, cystic lesions, chronic pancreatitis) requiring pancreatoduodenectomy

General inclusion criteria: 1. Subjects male or female, aged ≥ 18 years 2. given written informed consent to participate in the trial Indication-specific inclusion criteria: 3. planned for pancreatoduodenectomy 4. smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)

General Exclusion Criteria: 1. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial 2. Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial. 3. Known or persistent abuse of medication, drugs or alcohol Exclusion criteria regarding special restrictions for females: 4. Current or planned pregnancy or nursing women 5. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study du-ration (such as oral, injectable, or implantable contraceptives, or intrau-terine contraceptive devices) unless they are surgically sterilized / hys-terectomized or there are any other criteria considered sufficiently relia-ble by the investigator in individual cases Indication specific exclusion criteria: 6. distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guide-lines) 7. former gastrectomy 8. liver fibrosis/cirrhosis 9. Known history of hypersensitivity to nicotine or a compound of the in-vestigational drug 10. Systemic skin diseases (e.g. Lupus erythematodes) 11. Immediately after heart attack 12. Severe cardiac arrhythmia 13. Stroke that occurred shortly before