One vs. Two Stents for Gallbladder Disease

Conditions

• Biliary Colic
• Cholecystitis
• Recurrent Cholecystitis
• Symptomatic Gallbladder Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• ERCP with one stent placement — PROCEDURE
  One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
• ERCP with two stent placement — PROCEDURE
  Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP

Study Details

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.

Key Dates

Start date

Dec 12, 2025

Status verified

Dec 2025

Primary completion

May 27, 2027

Completion

May 27, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ONE STENT ARM
  Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease
• Active Comparator: TWO STENT ARM
  Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease.

Primary Outcome Measure

Clinical Success [ Time Frame: 6 months ]

Central Contacts

• Liz Lemke
  507-266-3317
  [email protected]

Locations (1)

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