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TransNiDeG - The Effect of Transcutaneous Nicotine Administration on the Development of Delayed Gastric Emptying following Pancreatoduodenectomy - a randomized, placebo-controlled, double-blind, multicenter trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503349-71-00
Acronym
CHI-202002
Enrollment
240
Registered
2023-08-07
Start date
2023-10-30
Completion date
Unknown
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatodudoenectomy

Brief summary

Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery

Detailed description

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

Interventions

DRUGPatchinga Freestyle Libre 3 Patch
DRUGNicotinell 14 mg / 24-Stunden-Pflaster

Sponsors

Rheinische Friedrich Wilhelms Universitaet Bonn
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026