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Study on Nicotine Patch for Preventing Delayed Gastric Emptying in Patients After Pancreatoduodenectomy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment on a condition known as delayed gastric emptying, which can occur after a surgical procedure called pancreatoduodenectomy. This surgery involves removing parts of the pancreas and the small intestine. The treatment being tested is a patch called Nicotinell 14 mg / 24-Stunden-Pflaster, which contains nicotine. The study will compare the effects of this nicotine patch to a placebo to see if it can help reduce the development and severity of delayed gastric emptying after the surgery.

The purpose of the study is to assess whether the nicotine patch can improve recovery by preventing or lessening the symptoms of delayed gastric emptying. Participants in the study will be randomly assigned to receive either the nicotine patch or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The treatment will be applied for a period of seven days, and participants will be monitored for any changes in their condition.

Throughout the study, researchers will observe various factors, such as the need for a naso-gastric tube, the ability to eat solid food, and any occurrences of vomiting or stomach swelling. They will also track any side effects or complications that may arise. The study aims to provide valuable insights into whether the nicotine patch can be a beneficial treatment option for patients undergoing pancreatoduodenectomy, potentially improving their recovery and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent, confirming your willingness to participate.

    You must be at least 18 years old and scheduled for a surgical procedure called pancreatoduodenectomy.

  2. Step 2

    Preparation for treatment

    If you are a smoker, you must agree to stop smoking for the duration of the treatment, which lasts from Day 1 to Day 7.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive a transdermal patch that administers nicotine through your skin.

    The patch is called Nicotinell 14 mg / 24-Stunden-Pflaster and is applied once every 24 hours for a total of 7 days.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, your health will be closely monitored to assess the effect of the treatment on delayed gastric emptying, a condition that may occur after your surgery.

    You will be evaluated for any side effects or complications, such as difficulty in tolerating solid food, vomiting, or the need for a naso-gastric tube within the first 21 days after surgery.

  5. Step 5

    Completion of the trial

    At the end of the trial, your overall health and recovery will be assessed, including any changes in your quality of life.

    The trial is expected to conclude by July 31, 2025.

Who can join the trial?

4 criteria

  • Must be 18 years or older.
  • Must have given written informed consent to participate in the trial. This means you agree to join the study after being told all the details.
  • Must be planned for pancreatoduodenectomy. This is a type of surgery involving the pancreas and the duodenum, which is part of the small intestine.
  • If you are a smoker, you must be willing to stop smoking for the duration of the study medication application, which is from Day 1 to Day 7.

Who cannot join the trial?

3 criteria

  • Patients who have not undergone a pancreatoduodenectomy cannot participate. This is a type of surgery involving the pancreas and the duodenum, which is part of the small intestine.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means individuals who might be at higher risk of harm or exploitation.
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Investigated drugs

Nicotine is being tested in this clinical trial. It is a substance commonly found in tobacco products. In this study, nicotine is administered through the skin using a patch. The goal is to see if it can help prevent or reduce the severity of delayed gastric emptying, which is a condition where the stomach takes longer to empty its contents. This condition can occur after a type of surgery called pancreatoduodenectomy. The trial aims to find out if nicotine can improve recovery by helping the stomach function more normally after surgery.

What is already known about the treatment

Nicotine – Nicotine is administered through the skin using a patch, which allows the substance to enter the bloodstream gradually. It is currently being studied in clinical trials to see if it can help with delayed gastric emptying, a condition that can occur after a type of surgery called pancreatoduodenectomy. The main therapeutic indication being investigated is its potential to reduce the severity of this condition. At the molecular level, nicotine works by binding to specific receptors in the nervous system, which can influence the movement of the stomach and intestines. It is classified pharmacologically as a stimulant and is commonly known for its presence in tobacco products.

Investigated diseases

Delayed Gastric Emptying – Delayed gastric emptying is a condition where the stomach takes longer than normal to empty its contents into the small intestine. This can occur after surgical procedures like pancreatoduodenectomy. The condition is characterized by symptoms such as nausea, vomiting, bloating, and a feeling of fullness after eating. It can lead to difficulties in maintaining adequate nutrition and hydration. The severity of delayed gastric emptying can vary, with some cases being mild and others more severe. The condition is often temporary but can persist in some individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503349-71-00Protocol codeCHI-202002Estimated enrolment240 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).