Biliary Colic, Cholecystitis, Recurrent Cholecystitis, Symptomatic Gallbladder Disease
Conditions
Keywords
gallbladder disease, symptomatic gallbladder disease, Recurrent cholecystitis, biliary colic, cystic duct stent, transpapillary gallbladder stents, high surgical risk patient, nonsurgical management gallbladder disease, gallbladder decompression, acute cholecystitis in non-cholecystectomy candidate
Brief summary
This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) among patients who are not immediate surgical candidates for removal of their gallbladder. The study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and technical success, defined as successful placement of stents into the gallbladder. The main questions it aims to answer are: 1. Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent? 2. Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies? Researchers will compare outcomes between patients randomized to one stent versus two stents to determine which approach provides better long-term gallbladder drainage and fewer recurrent events. Participants will: Be evaluated for eligibility and provide informed consent prior to undergoing an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopy where a guidewire is placed into the bile duct from the small intestine. They will then undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents. All participants will receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention.
Interventions
PROCEDUREERCP with one stent placement
One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
PROCEDUREERCP with two stent placement
Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis. 2. Age 18-95. 3. Participants must be willing and able to provide informed consent 4. Referred for ERCP for management of 1) suspected choledocholithiasis 2) acute biliary pancreatitis and/or 3) acute cholangitis in whom cholecystectomy is expected to be delayed \> 30 days or are deemed to not be surgical candidates for cholecystectomy.
Exclusion criteria
1. Inability to provide informed consent 2. History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP 3. History of primary sclerosing cholangitis 4. History of gallbladder cancer 5. History of cholecystectomy 6. Unsuccessful biliary cannulation during ERCP -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 6 months | Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 1 day | Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder. |
| Time to Recurrence | 6 months | The amount of time (days) from the index procedure to when a recurrence occurs |
| Reintervention | 6 months | The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure |
| Adverse Events | 6 months | The type and severity of adverse events that occur related to the index procedure for stent placement |
Countries
United States
Contacts
Primary ContactLiz Lemke
Outcome results
None listed