Endoscopic Decompression for Chronic Pancreatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether endoscopic decompression (using a tube with a camera to clear blockages) can improve pancreatic function in people with chronic pancreatitis. Participants will either undergo this procedure or receive standard medical care to compare outcomes. The trial aims to gather preliminary data to determine if a larger study is warranted. People with chronic pancreatitis who have mild symptoms and were incidentally diagnosed may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative procedure.
What prior data suggests that endoscopic pancreatic duct decompression is safe for patients with chronic pancreatitis?
Research has shown that endoscopic pancreatic duct decompression is usually safe, though some risks exist. In one study, 17% of patients experienced side effects, with 6% facing serious issues. This indicates that while most patients do well, a few may encounter significant problems. Another study found this procedure to be a safe, less invasive option for those with pain from chronic pancreatitis, though some patients required additional treatments after the initial one.
These findings suggest that while the procedure is generally well-tolerated, complications can occur, and some individuals might need further treatments. Prospective participants should discuss any concerns with their doctor and understand both the benefits and risks before deciding to join a clinical trial.12345Why are researchers excited about this trial?
Endoscopic pancreatic duct decompression is unique because it offers a direct, minimally invasive approach to alleviate pressure in the pancreatic duct, which is often a source of pain and complications in chronic pancreatitis. Unlike standard treatments such as pain management with medications or more invasive surgical interventions, this endoscopic technique targets the root cause by relieving ductal obstruction. Researchers are excited about this method because it has the potential to provide significant relief with a lower risk of complications and faster recovery time compared to traditional surgeries.
What evidence suggests that endoscopic pancreatic duct decompression is effective for chronic pancreatitis?
This trial will compare endoscopic pancreatic duct decompression with standard medical management for chronic pancreatitis. Research has shown that endoscopic pancreatic duct decompression might alleviate symptoms in people with chronic pancreatitis. This procedure uses an endoscope, a flexible tube with a camera, to clear blockages in the pancreatic duct. Although evidence remains limited, early results suggest that removing these blockages can reduce pain and improve pancreatic function by enhancing enzyme flow. Clearing the duct might also help prevent further pancreatic damage over time. More studies are needed to confirm these benefits, but initial results appear promising for those suffering from this condition.678910
Who Is on the Research Team?
Samuel Han, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults (18+) with chronic pancreatitis who have a blocked pancreatic duct seen on imaging, mild to moderate pain not needing daily opioids, and are willing to follow study procedures. People must have had no more than one mild pancreatitis episode in the past year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline metabolic testing using mixed-meal tolerance testing to assess endocrine function
Treatment
Participants receive either endoscopic pancreatic duct decompression or medical management alone
Follow-up
Participants are monitored for changes in pancreatic endocrine and exocrine function
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopic pancreatic duct decompression
Trial Overview
The study compares two groups: one gets an endoscopic procedure to clear the blocked pancreatic duct, and the other does not get this procedure. Participants are randomly assigned to each group. The goal is to see if clearing the blockage improves pancreas function.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in the intervention arm will receive endoscopic pancreatic duct decompression.
The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Indiana University
Collaborator
Citations
Pancreatitis - Symptoms and causes
Chronic pancreatitis is a long-term condition that does not heal or improve. The damage to the pancreas can get worse over time and cause ...
Chronic Pancreatitis | MedlinePlus
Pancreatitis is inflammation of the pancreas. Pancreatitis can be acute or chronic. Learn about pancreatitis symptoms and treatment.
Pancreatitis: What It Is, Symptoms & Treatment
Most people get better within several days. More severe cases may take longer to heal. Chronic pancreatitis: This is long-term inflammation
Pancreatitis
Pancreatitis is the redness and swelling (inflammation) of the pancreas. This happens when digestive juices or enzymes attack the pancreas.
Pancreatitis - NIDDK
Acute pancreatitis is short term and may go away in a few days with treatment. Chronic, or long-lasting, pancreatitis can get worse over time and cause lasting ...
Long-term outcome after endoscopic ultrasound-guided ...
Adverse events occurred in 17% (95%CI 7-33%), including severe events in 6%. Reintervention was required in 29% of patients, During follow up, ...
Endoscopic management of chronic pancreatitis
Persistent stricture and recurrence after initial resolution were found in five (10.4%) and three (7%) cases, respectively. 39. The major drawback with this ...
Long-term outcomes of endoscopic vs surgical drainage ...
Of the patients treated by endoscopy, 68% required additional drainage compared with 5% in the surgery group (P = .001). Hospital stay and costs ...
Endoscopic stent therapy in patients with chronic pancreatitis
These data suggest that endoscopic therapy is a safe, minimally invasive, and effective procedure in patients who experience pain attacks during ...
Long-term outcome after endoscopic ultrasound-guided ... - IRIS
Chronic pancreatitis accounted for 54% of indications. Technical success was achieved in all patients. Overall clinical success was 80% (95% ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.