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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
DRK Kliniken Berlin	Berlin	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Muenchen Klinik gGmbH	Munich	Germany
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Klinikum St. Georg gGmbH	Leipzig	Germany
Vtnzdtmicgbtzcqnkm Hrzjbhje Gkdc	Hanover	Germany
udsax Rsgzjvsw Mljxpfos Srydlhypmdj Hvvjxigr ir Khnprf Lqx	Cracow	Poland
Uankguwftdzvlbnoihfek Maxiiqjn Amj	Munster	Germany
Phhbfsosg Ituieyrb Mmmoikgp Mpztfpeiwjly Sgyid Wqevrqqnmeic I Acebeujbnlcbx	Warsaw	Poland
Nsypbhxv Iixbnqsp Oyisuxbtq Iva Mnbuj Swqqoksoqysehvtcnrsrcjjyeqzu Ifwnemia Bbwkkrgk	Cracow	Poland
Untjcaljuwfupo Clmwozd Kjstjqrpi	Gdansk	Poland
Hebontiz Dd Lq Szyye Cnce I Svlh Pzc	Barcelona	Spain
Kwbbazrq dco Unfxiavjfkuh Mrvfwztj Ahj	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.09.2024
Poland	Recruiting	02.09.2024
Spain	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Pancreas Powder

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.

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.

Trial ID:

2024-512798-29-00

Protocol code:

PANC-CAP-3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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