Recurrent CholecystitisNCT07222527
One vs. Two Stents for Gallbladder Disease
A study testing ERCP with one stent placement and ERCP with two stent placement in people with Recurrent Cholecystitis and Cholecystitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Recurrent Cholecystitis, Cholecystitis, Symptomatic Gallbladder Disease
- What is being tested?
- ERCP with one stent placement and ERCP with two stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 27 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.
- Age 18-95.
- Participants must be willing and able to provide informed consent
- 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.
Who cannot join
- Inability to provide informed consent
- History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP
- History of primary sclerosing cholangitis
- History of gallbladder cancer
- History of cholecystectomy
- Unsuccessful biliary cannulation during ERCP -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Liz Lemke, 507-266-3317, Lemke.Elizabeth@mayo.edu
Eric Vargas
About this study
Official title: A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
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.
Read more
The main questions it aims to answer are:
- Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?
- 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.
- Being tested
- ERCP with one stent placement, ERCP with two stent placement
- 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
- Medical subject headings
- Cholecystitis, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with one stent placementProcedure or surgery
One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
ERCP with two stent placementProcedure or surgery
Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP
| Study group | Role | What they receive |
|---|---|---|
| ONE STENT ARM | Active comparator | Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease Receives: Procedure: ERCP with one stent placement |
| TWO STENT ARM | Active comparator | Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease. Receives: Procedure: ERCP with two stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
Measured: 6 months
Secondary outcomes (4)
Technical Success
Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.
Measured: 1 day
Time to Recurrence
The amount of time (days) from the index procedure to when a recurrence occurs
Measured: 6 months
Reintervention
The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure
Measured: 6 months
Adverse Events
The type and severity of adverse events that occur related to the index procedure for stent placement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start12 Dec 2025
- Primary completion27 May 2027 (estimated)
- Study completion27 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent CholecystitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric J. Vargas Valls, Mayo Clinic
- Investigators
- Eric Vargas, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222527
- Sponsor's protocol ID
- 24-011410
- Other IDs
- 95352001
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and outcomes will be shared after study approval of request from investigators by the study team
Publications
Storm AC, Vargas EJ, Chin JY, Chandrasekhara V, Abu Dayyeh BK, Levy MJ, Martin JA, Topazian MD, Andrews JC, Schiller HJ, Kamath PS, Petersen BT. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-748.e1. doi: 10.1016/j.gie.2021.03.025. Epub 2021 Mar 30.
PubMed 33798540
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
- ClinicalTrials.gov ID
- NCT07222527
- Acronym / sponsor ID
- 24-011410
- Keywords
- gallbladder disease, symptomatic gallbladder disease, Recurrent cholecystitis, biliary colic, cystic duct stent, transpapillary gallbladder stents, high surgical risk patient, nonsurgical management gallbladder disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2028 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONE STENT ARM | Active comparator | Procedure: ERCP with one stent placementParticipant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease |
| TWO STENT ARM | Active comparator | Procedure: ERCP with two stent placementParticipant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.
- Age 18-95.
- Participants must be willing and able to provide informed consent
- 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.
Key exclusion criteria (6 listed)
- Inability to provide informed consent
- History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP
- History of primary sclerosing cholangitis
- History of gallbladder cancer
- History of cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP with one stent placementOne transpapillary cystic duct stent will be placed into the gallbladder via ERCP | Procedure or surgery | ONE STENT ARM |
| ERCP with two stent placementTwo transpapillary cystic duct stents will be placed into the gallbladder via ERCP | Procedure or surgery | TWO STENT ARM |
Primary outcome
Clinical Success
Time frame: 6 months
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
4 secondary outcomes
Technical Success
Time frame: 1 day
Time to Recurrence
Time frame: 6 months
Reintervention
Time frame: 6 months
Adverse Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 33798540Storm AC, Vargas EJ, Chin JY, Chandrasekhara V, Abu Dayyeh BK, Levy MJ, Martin JA, Topazian MD, Andrews JC, Schiller HJ, Kamath PS, Petersen BT. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-748.e1. doi: 10.1016/j.gie.2021.03.025. Epub 2021 Mar 30.
- Individual participant dataSharing planned: Yes. Deidentified participant data and outcomes will be shared after study approval of request from investigators by the study team
Related trials for Recurrent Cholecystitis
Recruiting
Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD
Acute Cholecystitis
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Vargas principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with one stent placement and ERCP with two stent placement in people with Recurrent Cholecystitis and Cholecystitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liz Lemke (507-266-3317, Lemke.Elizabeth@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07222527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.