CholelithiasisNCT07490730
Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones
An observational study of Cholelithiasis, run by North Estonia Medical Centre at 1 site in Estonia.
Trial summary
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- How many people
- 100 participants
- Where
- 1 siteEstonia
- Study dates
- 1 May 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients with radiographically confirmed common bile duct stones eligible for emergency laparoscopic cholecystectomy
Who may be able to join
- Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct
- Eligible for laparoscopic cholecystectomy
- Understood and signed written consent form
Who cannot join
- Severe cholangitis (according to TOKYO2018 guidelines)
- Severe pancreatitis (BISAP score of 3 or more)
- Septic shock
- Common bile duct stones larger than 15 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones: A Prospective Validation Study With Postoperative MRCP Confirmation
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
Read the detailed description
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
- Conditions
- Cholelithiasis
- Keywords
- Common bile duct stones, Laparoscopic cholecystectomy, MRT, Endoscopic balloon dilatation
- Medical subject headings
- Cholelithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct clearance
The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)
Measured: 30 days
Secondary outcomes (1)
Operative time, 30-day post-operative complications, hospital length of stay
The duration of the operation in minutes from incision to skin closure; post-operative complications that were registered within 30 days after the operation, patients' hospital length of stay in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 May 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
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 CholelithiasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Estonia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490730
- Sponsor's protocol ID
- NorthEstoniaMC
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lipping E, Saar S, Kirss J, Aaspollu H, Bahhir A, Gapejeva O, Kangur T, Rauk M, Reinsoo A, Teder A, Talving P. Antegrade transcystic balloon dilatation in emergency laparoscopic cholecystectomy with MRCP validation. Eur J Trauma Emerg Surg. 2026 Sep 1;52(1):279. doi: 10.1007/s00068-026-03323-0.
PubMed 42678398
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones: A Prospective Validation Study With Postoperative MRCP Confirmation
- ClinicalTrials.gov ID
- NCT07490730
- Acronym / sponsor ID
- NorthEstoniaMC
- Conditions
- Cholelithiasis
- Keywords
- Common bile duct stones, Laparoscopic cholecystectomy, MRT, Endoscopic balloon dilatation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- North Estonia Medical CentreUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 24 Mar 2026 (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.
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
Detailed description
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients with radiographically confirmed common bile duct stones eligible for emergency laparoscopic cholecystectomy
Key inclusion criteria (3 listed)
- Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct
- Eligible for laparoscopic cholecystectomy
- Understood and signed written consent form
Key exclusion criteria (4 listed)
- Severe cholangitis (according to TOKYO2018 guidelines)
- Severe pancreatitis (BISAP score of 3 or more)
- Septic shock
- Common bile duct stones larger than 15 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Common bile duct clearance
Time frame: 30 days
The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)
1 secondary outcome
Operative time, 30-day post-operative complications, hospital length of stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42678398Lipping E, Saar S, Kirss J, Aaspollu H, Bahhir A, Gapejeva O, Kangur T, Rauk M, Reinsoo A, Teder A, Talving P. Antegrade transcystic balloon dilatation in emergency laparoscopic cholecystectomy with MRCP validation. Eur J Trauma Emerg Surg. 2026 Sep 1;52(1):279. doi: 10.1007/s00068-026-03323-0.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by North Estonia Medical Centre at 1 site in Estonia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Mar 2026. 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 Estonia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common bile duct clearance (time frame: 30 days). 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 NCT07490730, 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 24 Mar 2026.