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Study on Pancreatic Enzyme Replacement Therapy for Adults with Pancreatic Exocrine Insufficiency After Pancreatic Surgery

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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 patients who have undergone a total removal of the pancreas, a procedure known as a total pancreatectomy. After this surgery, many patients experience a condition called Pancreatic Exocrine Insufficiency (PEI), where the pancreas no longer produces enough enzymes to help digest food. The study is investigating the use of a treatment called Pancreatic Enzyme Replacement Therapy (PERT), specifically using a medication known as Creon® 35,000. This medication contains a mix of enzymes that help with digestion.

The purpose of the study is to understand how many patients need doses higher than 70,000 units of Creon® per main meal to manage their condition effectively. Participants will take the medication orally in the form of gastro-resistant capsules, which are designed to withstand stomach acid and release the enzymes in the intestines where they are needed. The study will monitor various aspects of the participants' health, including their nutritional status, body weight, and quality of life, as well as any side effects related to the treatment.

Throughout the study, participants will keep a diary to record their symptoms, such as abdominal pain and changes in stool frequency and consistency. The study aims to provide valuable information on the effectiveness and safety of Creon® for managing PEI after pancreatic surgery, helping to improve treatment strategies for patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on criteria such as age (18 to 80 years), previous total pancreatectomy, and presence of pancreatic exocrine insufficiency (PEI) symptoms.
Written informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate symptoms and nutritional status. This includes a clinical global impression (CGI) and laboratory tests to identify any nutritional deficits.
If not already on treatment, proton pump inhibitors are started at this stage.
Step 3
Treatment initiation
The treatment involves taking Creon 35,000, a pancreatic enzyme replacement therapy, in the form of gastro-resistant capsules.
The medication is taken orally with meals, and the dosage may be adjusted based on individual needs, particularly if doses higher than 70,000 units per main meal are required.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring of symptoms, nutritional status, and diabetes parameters (such as glucose and HbA1c levels) is conducted.
Participants are required to maintain an electronic diary to record clinical symptoms, stool frequency, and any adverse events related to the treatment.
Step 5
Evaluation of outcomes
The primary outcome is the percentage of patients needing higher than approved doses of the treatment.
Secondary outcomes include changes in body mass index (BMI), body weight, quality of life, and the incidence of any adverse events.
Step 6
Completion
The study is expected to conclude by October 2025, with final evaluations conducted to assess the overall effectiveness and safety of the treatment.

Who can join the trial?

8 criteria

Both men and women of any ethnic background can participate.
Participants must be between 18 and 80 years old, including those ages.
Participants must have had a total pancreatectomy, which means the entire pancreas was removed, at least 2 weeks before the study starts. Those who had surgery because of pancreatic cancer can join even if they are receiving additional cancer treatments like chemotherapy or radiation.
Participants must have symptoms of Pancreatic Exocrine Insufficiency (PEI), which means the pancreas is not making enough digestive enzymes. This should be evaluated by the study doctor as at least moderate and include a nutritional deficit, meaning at least one lab test result is not normal.
Participants should be taking Proton Pump Inhibitors, which are medicines that reduce stomach acid. If not already taking them, they should start at the first study visit.
Participants must be willing and able to follow the study rules, including filling out an electronic diary during the study.
Participants need to provide written consent, which means they agree to join the study after understanding what it involves.
Participants should have a life expectancy that matches the length of the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

Creon is a medication used in this study to help patients who have trouble digesting food after pancreatic surgery. It contains enzymes that are normally produced by the pancreas and helps break down fats, proteins, and carbohydrates in the food you eat. This medication is used to replace the enzymes that your pancreas is not making enough of, which can help improve digestion and nutrient absorption.

Pancreas Powder

What is already known about the treatment

Creon – Creon is administered orally in the form of capsules and is used to treat pancreatic exocrine insufficiency (PEI), particularly in patients who have undergone total pancreatectomy. It is currently well-established in medical practice and literature as a pancreatic enzyme replacement therapy (PERT). The main therapeutic indication is to aid digestion by supplementing the body's natural enzymes, which are deficient in these patients. At the molecular level, Creon works by breaking down fats, proteins, and carbohydrates in the digestive tract, facilitating their absorption. It is classified pharmacologically as a digestive enzyme supplement.

Investigated diseases

Pancreatic Exocrine Insufficiency – This condition occurs when the pancreas does not produce enough digestive enzymes, leading to difficulties in digesting food. It often results from damage to the pancreas, such as from a total pancreatectomy. Symptoms typically include abdominal pain, flatulence, and changes in stool consistency and frequency. Patients may experience weight loss and nutritional deficiencies due to poor absorption of nutrients. The condition requires careful management to maintain proper digestion and nutrition.