30 Participants NeededMy employer runs this trial

Endoscopic Decompression for Chronic Pancreatitis

LO
Overseen ByLuis Ospina, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SH

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

I have chronic pancreatitis found on imaging but do not have symptoms.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
See 4 more

Exclusion Criteria

Active alcohol use within 2 months of enrollment
I have a mass or suspected cancer in the head of my pancreas.
History of diabetes defined as either a HbA1c ≥ 6.5% or a fasting glucose ≥ 126 mg/dL
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline metabolic testing using mixed-meal tolerance testing to assess endocrine function

1 week
1 visit (in-person)

Treatment

Participants receive either endoscopic pancreatic duct decompression or medical management alone

Until pancreatic duct decompression is achieved

Follow-up

Participants are monitored for changes in pancreatic endocrine and exocrine function

6 months
2 visits (in-person) for metabolic testing at baseline and 6 months post-randomization

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

Group I: Endoscopic pancreatic duct decompression (Intervention Arm)Experimental Treatment1 Intervention
Group II: No endoscopic intervention (Control Arm)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

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% ...