RecruitingOBSERVATIONAL

Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety

This study investigates a common issue after pancreas surgery (pancreatectomy): a temporary rise in a blood chemical called amylase. While this high amylase might suggest inflammation of the pancreas, called pancreatitis, it's not always clear how much it affects how well patients recover. Doctors want to carefully track amylase levels and other body measurements to see if they can predict problems early and improve patient safety. By doing this, they hope to better understand and manage potential complications after pancreas surgery, helping patients have a smoother and safer recovery.

At a glance

Status

Recruiting

Sponsor

Technische Universität Dresden

Enrolment target

150

Start

18 Jul 2023

Estimated completion

01 Jul 2026

Pancreatectomy Hyperamylasemia Pancreatitis, Acute

What is this study about?

When someone has surgery on their pancreas, it's a big operation. Sometimes, after this surgery, a chemical in the blood called amylase can go up. Previously, doctors thought this rise in amylase definitely meant there was a problem like inflammation of the pancreas, which can lead to complications. However, it's not always that simple, and a simple rise in amylase might not always mean a severe issue.

This study aims to look closely at this situation. Researchers want to observe many patients who have had pancreas surgery to see how often their amylase levels go up and if this rise truly leads to problems or affects their recovery in a significant way. They will also look at other tests in the blood to get a clearer picture.

The main goal is to improve how doctors understand and react to these changes after surgery. By getting a clearer idea of what a rise in amylase actually means, and how it relates to potential inflammation of the pancreas, they can develop better ways to manage patients’ care. This could lead to earlier and more effective treatments for any complications that arise, making recovery safer for everyone undergoing this surgery.

Key takeaways

The study explores why amylase levels rise after pancreas surgery.
It aims to improve understanding of pancreas inflammation post-surgery.
The goal is better patient safety and recovery after pancreas operations.
No new treatments or medications are being tested.
It involves closely monitoring blood tests and recovery after surgery.

Who may be eligible?

This study is looking for patients who are having surgery on their pancreas because of a health problem. To join, you need to be an adult, specifically between 18 and 85 years old. You must also be willing to take part and provide your written permission to be in the study.

However, some people won't be able to join. This includes if you've had certain procedures for severe inflammation of the pancreas, if you're under 18, or if you're having a different type of surgery that doesn't involve removing part of the pancreas. Also, if you're having your entire pancreas removed in one operation, or if you don't provide written permission, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having surgery on your pancreas?
Are you between 18 and 85 years old?
Are you willing to participate and sign a consent form?
Have you not had certain procedures for severe pancreas inflammation before?

Answer every question to see your result.

What does participation involve?

The information provided does not detail specific visits, assessments, medication, or follow-up procedures. Generally, in studies like this, your doctors would collect extra information during your standard care after pancreas surgery. This might involve additional blood tests at specific times and careful monitoring of your recovery. There are no new medications involved, as this study focuses on understanding existing outcomes. The total duration of your participation would likely cover your hospital stay and possibly a period shortly after discharge, but specific timelines are not mentioned.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gathered could help improve care for future patients undergoing pancreas surgery. There are no new treatments or medications involved, so the main risks would be those associated with additional blood samples, if requested beyond routine care, or the time commitment. You are always free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is 'amylase'?

Amylase is a natural chemical made by your pancreas. It helps digest food. Doctors check its level in your blood to see how your pancreas is working.

What is 'pancreas surgery'?

Pancreas surgery is an operation to remove part or all of your pancreas, which is an organ that helps with digestion and making hormones.

Why is this study important?

This study wants to help doctors better understand what a high amylase level means after pancreas surgery, so they can provide safer and more effective care for patients.

Will I get any new medicine in this study?

No, this study does not involve new medicines. It focuses on understanding existing changes in your body after surgery.

What results will the study provide?

The study aims to improve how doctors define and manage pancreas inflammation after surgery, which could lead to better patient recovery.

How to find out more

Olga Radulova-Mauersberger, Dr. med.

studienzentrum-vtg@ukdd.de +49 351 458-0 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.