Stent Placement for Gallbladder Disorders

Overseen By Liz Lemke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Surgically altered anatomy, Gallbladder cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using two stents instead of one can better prevent recurring gallbladder issues, such as infections or pain from gallstones, in individuals who can't have their gallbladder removed immediately. The goal is to determine if two stents more effectively reduce symptoms and avoid complications compared to one. Participants will undergo a procedure called ERCP (Endoscopic Retrograde Cholangiopancreatography), which involves placing the stents to aid in gallbladder drainage. Individuals who have experienced cholecystitis (gallbladder inflammation), biliary colic (bile duct pain), or gallstone pancreatitis and aren't immediate candidates for surgery might be suitable for this trial. As an unphased trial, this study offers patients a chance to contribute to innovative research that could enhance gallbladder treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this stent placement technique is safe for gallbladder disorders?

Research has shown that a procedure called ERCP, which involves placing one stent, is usually well-tolerated. However, some risks exist. In one study, a few patients experienced late side effects, such as gallbladder inflammation and stent migration into the small intestine.

For the procedure with two stents, studies indicate it is mostly successful. The stents were correctly placed in about 88.2% of cases, and the treatment worked as intended in about 81.3% of cases. However, similar risks, like gallbladder inflammation and the need for additional procedures, were noted.

Both treatments carry some risk of complications, such as pancreatic inflammation or stent migration. These factors are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for gallbladder disorders because they explore different stent placements during ERCP, a common procedure for gallbladder issues. Unlike traditional treatments that may rely on a single stent or different techniques for symptom relief, this trial tests one versus two stents in the bile duct. The potential benefit here is optimizing the stent placement to improve bile flow and alleviate symptoms more effectively. By understanding the impact of one versus two stents, researchers hope to refine treatment protocols and enhance patient outcomes in dealing with symptomatic gallbladder disease.

What evidence suggests that this trial's treatments could be effective for gallbladder disorders?

This trial will compare the effectiveness of using one stent versus two stents for treating symptomatic gallbladder disease. Research has shown that placing a small tube, called a stent, in the gallbladder can safely and effectively relieve symptoms caused by gallbladder problems. Participants in the one stent arm will undergo a procedure where one stent is placed, which usually eases symptoms. Meanwhile, participants in the two stent arm will have two stents placed. Studies suggest that using two stents might better prevent gallbladder issues from returning, with fewer recurring problems and a reduced need for additional unplanned medical care. ^{1 2 4 5 6}

Who Is on the Research Team?

Eric Vargas

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with gallbladder issues like inflammation, disorders, or stones who can't have surgery right away. They'll be part of a study to see if using two stents instead of one during an ERCP procedure prevents the return of these problems.

Inclusion Criteria

Participants must be willing and able to provide informed consent

I am a man or a woman not pregnant with gallbladder issues.

I am between 18 and 95 years old.

Exclusion Criteria

Inability to provide informed consent

I have had gallbladder cancer.

I have had my gallbladder removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents

1 day

1 visit (in-person)

Follow-up

Participants receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ERCP with one stent placement
• ERCP with two stent placement

Trial Overview The trial tests whether placing two cystic duct stents is better than one at stopping gallbladder disease from coming back in non-surgical candidates. It compares safety and success rates between the two methods by monitoring for complications and recurrence.

How Is the Trial Designed?

Group I: ONE STENT ARM Active Control 1 Intervention

Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease

Group II: TWO STENT ARM Active Control 1 Intervention

Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9784005/

Long-term outcomes of endoscopic transpapillary ... Although PTGBD is effective, it has not a few complications and has several problems may not be suitable for long-term treatment owing to external drainage.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07222527

ONE VS TWO STENTS FOR GALLBLADDER DISEASE This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00169-0/fulltext

Endoscopic Gallbladder Stenting to Prevent Recurrent ... Technical success was defined as successful insertion of the stent in the appropriate location confirmed by endoscopy or radiography. Clinical ...

4. giejournal.org giejournal.org/article/S0016-5107(04)02445-9/pdf

Endoscopic stent insertion into the gallbladder for ... Conclusions: Endoscopic stent placement in the gallbladder is a safe and an effective palliative treatment for patients with symptoms caused by gallbladder ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510704024459

Endoscopic stent insertion into the gallbladder for ... Conclusions. Endoscopic stent placement in the gallbladder is a safe and an effective palliative treatment for patients with symptoms caused by gallbladder ...

6. trial.medpath.com trial.medpath.com/clinical-trial/1fdac3241069da9e/nct07222527-transpapillary-cystic-duct-stents-recurrent-gallbladder-disease

ONE VS TWO STENTS FOR GALLBLADDER DISEASE The study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and ...