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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Romed Klinikum Rosenheim	Rosenheim	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Shycuharrbbl Kllcopkw Bojqbwoqtbfk gopul	Brunswick	Germany
Eoztkuvrinsohtjr Bajsce Bjdwxldwpln	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2023

Trial locations

Investigated drugs:

Nicotine

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.

Investigated diseases:

Pancreaticoduodenectomy

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 ID:

2023-503349-71-00

Protocol code:

CHI-202002

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?