PERT to Improve Quality of Life in Patients Undergoing

Status Recruiting

Clinical Trial Summary

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). PEI can be treated with oral pancreatic enzyme replacement therapy (PERT). However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

Clinical Trial Description

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). This occurs when there are not enough exocrine cells in the pancreas to release enzymes that help with food digestion. Potential symptoms may include bloating, cramping, large and foul-smelling bowel movements (steatorrhea), and other gastrointestinal symptoms like diarrhea, weight-loss, and malnutrition. PEI can be treated with oral pancreatic enzyme replacement therapy (PERT), for example CREON. Many studies have shown that treatment of PEI with PERT is safe, effective, and may improve quality of life, reduce weight loss, improve abdominal symptoms, and may improve overall survival. However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery. Participants will be recruited from Ontario hospitals using a two-step eligibility process (pre- and post-operatively) and randomized 1:1 to receive either standard of care or PERT plus standard of care. Outcome measures will be collected 1 and 3 months postoperatively. ;

Study Design

Related Conditions & MeSH terms

Exocrine Pancreatic Insufficiency
Pancreatic Insufficiency

Clinical Trial Details

NCT number	NCT05466838
Study type	Interventional
Source	Sunnybrook Health Sciences Centre
Contact	Paul Karanicolas, MD, PhD
Phone	416-480-4774
Email	Paul.karanicolas@sunnybrook.ca
Status	Recruiting
Phase	N/A
Start date	January 6, 2023
Completion date	April 2024

View Details

See also
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Completed	`NCT01144507` - Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
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Terminated	`NCT02985801` - PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	Phase 1/Phase 2
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Completed	`NCT00880100` - Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial — PERQ-UP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms