CholedocholithiasisDILAILANCT07503964
The Significance of Laparoscopic Transcystic Papilla Vateri Balloon Dilatation in Patients With Choledocholithiasis.
A study testing Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct., Laparoscopic Cholecystectomy. and Laparoscopic transcystic balloon dilatation of the papilla Vateri. in people with Choledocholithiasis and Choledocholithiasis With Cholecystitis, run by Riga East Clinical University Hospital at 1 site in Latvia.
Trial summary
A prospective randomized trial. It is planned to analyze groups of patients with cholecystitis and choledocholithiasis. As part of the study, after signing the consent, the patients will be divided into two groups that have indications for surgical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Choledocholithiasis With Cholecystitis
- What is being tested?
- Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct., Laparoscopic Cholecystectomy. and Laparoscopic transcystic balloon dilatation of the papilla Vateri.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLatvia
- Study dates
- 1 May 2025to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient older than 18 years,
- signed consent to participate in the study,
- diagnosed and confirmed choledocholithiasis,
- diameter of stones in the common bile duct no greater than 15 mm,
- patients whose general health condition will allow laparoscopic cholecystectomy.
Who cannot join
- patients under 18 years of age,
- patients who refused to sign a consent form to participate in the study,
- patients who, during conservative treatment (nitrates p/o), experience spontaneous antegrade evacuation of stones from the common bile duct,
- patients who have had a history of cholecystectomy,
- patients whose stone diameter in the common bile duct is greater than 15 mm,
- patients whose general health condition does not allow laparoscopic cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
A prospective randomized trial. It is planned to analyze groups of patients with cholecystitis and choledocholithiasis. As part of the study, after signing the consent, the patients will be divided into two groups that have indications for surgical therapy. A two-stage therapy will be applied to one group, where initially endoscopic retrograde cholangiopancreatography with evacuation of gallstone from the common bile duct will be prescribed, and as the second stage, patients will undergo surgery - laparoscopic cholecystectomy. For the second group, a one-stage therapy tactic will be applied, where during the operation (laparoscopic cholecystectomy), transcystic papilla Vateri balloon dilation with antegrade gallstone evacuation from the common bile duct will be applied. For patients who will be proven to have a stone in the common bile duct and patients who meet the study inclusion criteria, a sealed envelope will be placed in the medical history with a specific therapeutic tactic that will be applied to the patient's treatment. Each envelope will be assigned a number. Using a computer and a randomizer, an envelope with a number will be selected, which will be assigned to each patient. The postoperative course, duration of surgery, length of hospitalization, types of complications and their frequency after surgery, the creator of successful outcomes, the cost of the treatment method in the specific medical institution will be analyzed. The data will be processed with the IBM SPSS program and analyzed according to the parametric/non-parametric distribution of the data.
Read the detailed description
Choledocholithiasis, characterized by the presence of stones in the common bile duct, is a complex clinical condition that often requires invasive intervention to prevent complications such as cholangitis, jaundice, and biliary pancreatitis.
Several approaches are used for the treatment of choledocholithiasis. The National Institute for Health and Care Excellence (NICE) clinical guidelines on gallstone disease (2014) recommend bile duct clearance and laparoscopic cholecystectomy for patients with symptomatic or asymptomatic common bile duct stones.
NICE also recommends stone evacuation from the common bile duct during laparoscopic cholecystectomy or by endoscopic retrograde cholangiopancreatography (ERCP) before or during laparoscopic cholecystectomy. However, ERCP is associated with a significant rate of complications, ranging from 4% to 16%, including post-procedure pancreatitis, bleeding, cholangitis, and perforation. The most common and serious complication after ERCP is acute pancreatitis (Koc B. et al., 2014).
Often, cholecystectomy and ERCP are performed in two stages, and ERCP requires specialized equipment and the participation of a qualified endoscopist during the procedure. All of this increases the cost of the intervention and prolongs hospitalization.
We propose a new minimally invasive method for the treatment of choledocholithiasis. This method was approved and applied for the first time in Latvia at the Riga East Clinical University Hospital "Gaiļezers."
The method has several advantages compared to the standard two-stage approach (ERCP followed by laparoscopic cholecystectomy):
- The method is relatively fast;
- It is a single-stage procedure;
- It is safe and associated with a low rate of complications;
- The procedure can be performed by the operating surgeon, without the need for an endoscopist's presence.
Laparoscopic transcystic balloon dilation of the papilla Vateri (TPVBD), performed during laparoscopic cholecystectomy, is a minimally invasive surgical technique.
This technique involves the insertion of a balloon catheter through the cystic duct into the common bile duct, followed by balloon inflation to dilate the papilla, thereby facilitating the passage of stones into the duodenum (Maggie E. Bosley et al., 2021).
Laparoscopic transcystic balloon dilation is performed simultaneously with laparoscopic cholecystectomy, offering a single-stage approach. This reduces the need for a separate endoscopic procedure and effectively eliminates the risk of post-ERCP pancreatitis (Maggie E. Bosley et al., 2022).
Furthermore, the transcystic approach may be preferable for patients with complex biliary anatomy or small papillary openings, where endoscopic access may be challenging (Testoni, P. A., et al., 2016).
In contrast, ERCP is an endoscopic procedure in which a flexible endoscope is inserted through the mouth into the duodenum to visualize the papilla Vateri. Stones from the common bile duct are removed using specialized instruments such as baskets or balloons under direct endoscopic guidance (Mahalingam S. et al., 2021). However, ERCP is associated with a relatively high risk of complications (Koc B. et al., 2014), including pancreatitis, bleeding, perforation, and cholangitis, which may limit its suitability for certain patient groups (Manoharan D. et al., 2019; Shabanzadeh D. M. et al., 2021).
Although the use of ERCP in patients with choledocholithiasis is increasing, uncertainty remains as to whether single-stage or two-stage management provides better outcomes for patients.
A review of the available literature revealed a limited number of published studies on this method, even though it has been described and reported for several years.
In many published clinical cases, the detailed description and explanation of the laparoscopic transcystic papilla balloon dilation technique are lacking.
Therefore, it can be concluded that, to date, no standardized technique or protocol for the application of this method has been established. Several publications have retrospectively compared single-stage and two-stage treatment outcomes; however, a prospective, randomized study is needed for an in-depth analysis, as emphasized by other authors.
It is important to develop a safe and effective standardized technique and protocol for this method to facilitate its future use in clinical practice.
- Being tested
- Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct., Laparoscopic Cholecystectomy., Laparoscopic transcystic balloon dilatation of the papilla Vateri.
- Keywords
- Laparoscopic cholecystectomy, Choledocholithiasis, Transcystic papilla Vateri balloon dilation, Gallstone disease, Minimally invasive surgery, Common bile duct exploration, Complicated gallstone disease
- Medical subject headings
- Choledocholithiasis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct.Procedure or surgery
Endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction is a minimally invasive endoscopic procedure used for the treatment of choledocholithiasis. The procedure is performed under sedation or general anesthesia with the patient in the prone or semi-prone position.
A side-viewing duodenoscope is advanced into the duodenum, and the papilla of Vater is identified. The common bile duct is selectively cannulated using a guidewire-assisted technique, and contrast medium is injected under fluoroscopic control to visualize the biliary anatomy and confirm the presence of stones. If indicated, an endoscopic sphincterotomy is performed to enlarge the biliary orifice. Stones are then extracted using retrieval devices such as balloons or Dormia baskets, and complete duct clearance is confirmed by a final cholangiogram. A temporary biliary stent may be placed if drainage is inadequate. Patients are monitored after the procedure for potential complications.
Laparoscopic Cholecystectomy.Procedure or surgery
Laparoscopic cholecystectomy is a minimally invasive surgical procedure for the removal of the gallbladder, typically indicated for symptomatic cholelithiasis or cholecystitis. The procedure is performed under general anesthesia.
Four small trocars are inserted into the abdominal cavity to allow placement of a laparoscope and surgical instruments. The cystic duct and cystic artery are identified, clipped, and divided. The gallbladder is then dissected from the liver bed using electrocautery and removed through one of the port sites.
After ensuring hemostasis and inspecting the operative field, the instruments are withdrawn, and the port sites are closed. Patients usually recover quickly, with a shorter hospital stay and reduced postoperative pain compared to open cholecystectomy.
Laparoscopic transcystic balloon dilatation of the papilla Vateri.Procedure or surgery
Laparoscopic transcystic balloon dilatation of the papilla Vateri, performed during laparoscopic cholecystectomy, is a minimally invasive surgical technique. This technique involves the insertion of a balloon catheter through the cystic duct into the common bile duct, followed by inflation to dilate the papilla Vateri, facilitating stone passage into the duodenum.
| Study group | Role | What they receive |
|---|---|---|
| Two-step therapy method | Active comparator | Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct, and laparoscopic cholecystectomy (ERCP/LC). Receives: Procedure: Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct.; Procedure: Laparoscopic Cholecystectomy. |
| The one-step therapy method | Sham comparator | Laparoscopic cholecystectomy with intraoperative transcystic balloon dilatation of the papilla Vateri and anterograde evacuation of gallstones to duodenum (BD/LC). Receives: Procedure: Laparoscopic transcystic balloon dilatation of the papilla Vateri. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful common bile duct clearance rate
Successful clearance of the common bile duct, defined as absence of residual stones confirmed intraoperatively by cholangiography, compared between the two treatment groups.
Measured: Immediately after surgery
Secondary outcomes (5)
Length of hospital stay
Length of hospital stay measured as the number of days from the day of surgery to hospital discharge.
Measured: 7 days
Manipulation execution time
Duration of stone extraction procedure measured from insertion of the transcystic catheter or endoscope to completion of bile duct clearance.
Measured: Perioperatively. Unit of Measure: Minutes.
Frequency and types of complications
Incidence and type of intraoperative and postoperative complications classified according to the Clavien-Dindo classification. Unit of Measure - Number and percentage of patients (%).
Measured: From surgery through 10 to 30 days postoperatively
Technical success rate
Technical success defined as completion of the planned procedure without conversion to an alternative bile duct clearance method.
Unit of Measure - Percentage of patients (%)
Measured: Immediately after surgery
Total hospital treatment cost.
Total in-hospital treatment cost per patient calculated from hospital billing records, including procedural and hospitalization costs.
Unit of Measure-Cost in euros (€)
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 May 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riga East Clinical University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Latvia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503964
- Sponsor's protocol ID
- 06-A/25
- Acronym
- DILAILA
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Laparoscopic Transcystic Papilla Vateri Balloon Dilatation in Patients With Choledocholithiasis.
- ClinicalTrials.gov ID
- NCT07503964
- Acronym / sponsor ID
- DILAILA / 06-A/25
- Keywords
- Laparoscopic cholecystectomy, Choledocholithiasis, Transcystic papilla Vateri balloon dilation, Gallstone disease, Minimally invasive surgery, Common bile duct exploration, Complicated gallstone disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riga East Clinical University HospitalOther government
- Collaborators
- University of Latvia
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 31 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.
A prospective randomized trial. It is planned to analyze groups of patients with cholecystitis and choledocholithiasis. As part of the study, after signing the consent, the patients will be divided into two groups that have indications for surgical therapy. A two-stage therapy will be applied to one group, where initially endoscopic retrograde cholangiopancreatography with evacuation of gallstone from the common bile duct will be prescribed, and as the second stage, patients will undergo surgery - laparoscopic cholecystectomy. For the second group, a one-stage therapy tactic will be applied, where during the operation (laparoscopic cholecystectomy), transcystic papilla Vateri balloon dilation with antegrade gallstone evacuation from the common bile duct will be applied. For patients who will be proven to have a stone in the common bile duct and patients who meet the study inclusion criteria, a sealed envelope will be placed in the medical history with a specific therapeutic tactic that will be applied to the patient's treatment. Each envelope will be assigned a number. Using a computer and a randomizer, an envelope with a number will be selected, which will be assigned to each patient. The postoperative course, duration of surgery, length of hospitalization, types of complications and their frequency after surgery, the creator of successful outcomes, the cost of the treatment method in the specific medical institution will be analyzed. The data will be processed with the IBM SPSS program and analyzed according to the parametric/non-parametric distribution of the data.
Detailed description
Choledocholithiasis, characterized by the presence of stones in the common bile duct, is a complex clinical condition that often requires invasive intervention to prevent complications such as cholangitis, jaundice, and biliary pancreatitis.
Several approaches are used for the treatment of choledocholithiasis. The National Institute for Health and Care Excellence (NICE) clinical guidelines on gallstone disease (2014) recommend bile duct clearance and laparoscopic cholecystectomy for patients with symptomatic or asymptomatic common bile duct stones.
NICE also recommends stone evacuation from the common bile duct during laparoscopic cholecystectomy or by endoscopic retrograde cholangiopancreatography (ERCP) before or during laparoscopic cholecystectomy. However, ERCP is associated with a significant rate of complications, ranging from 4% to 16%, including post-procedure pancreatitis, bleeding, cholangitis, and perforation. The most common and serious complication after ERCP is acute pancreatitis (Koc B. et al., 2014).
Often, cholecystectomy and ERCP are performed in two stages, and ERCP requires specialized equipment and the participation of a qualified endoscopist during the procedure. All of this increases the cost of the intervention and prolongs hospitalization.
We propose a new minimally invasive method for the treatment of choledocholithiasis. This method was approved and applied for the first time in Latvia at the Riga East Clinical University Hospital "Gaiļezers."
The method has several advantages compared to the standard two-stage approach (ERCP followed by laparoscopic cholecystectomy):
- The method is relatively fast;
- It is a single-stage procedure;
- It is safe and associated with a low rate of complications;
- The procedure can be performed by the operating surgeon, without the need for an endoscopist's presence.
Laparoscopic transcystic balloon dilation of the papilla Vateri (TPVBD), performed during laparoscopic cholecystectomy, is a minimally invasive surgical technique.
This technique involves the insertion of a balloon catheter through the cystic duct into the common bile duct, followed by balloon inflation to dilate the papilla, thereby facilitating the passage of stones into the duodenum (Maggie E. Bosley et al., 2021).
Laparoscopic transcystic balloon dilation is performed simultaneously with laparoscopic cholecystectomy, offering a single-stage approach. This reduces the need for a separate endoscopic procedure and effectively eliminates the risk of post-ERCP pancreatitis (Maggie E. Bosley et al., 2022).
Furthermore, the transcystic approach may be preferable for patients with complex biliary anatomy or small papillary openings, where endoscopic access may be challenging (Testoni, P. A., et al., 2016).
In contrast, ERCP is an endoscopic procedure in which a flexible endoscope is inserted through the mouth into the duodenum to visualize the papilla Vateri. Stones from the common bile duct are removed using specialized instruments such as baskets or balloons under direct endoscopic guidance (Mahalingam S. et al., 2021). However, ERCP is associated with a relatively high risk of complications (Koc B. et al., 2014), including pancreatitis, bleeding, perforation, and cholangitis, which may limit its suitability for certain patient groups (Manoharan D. et al., 2019; Shabanzadeh D. M. et al., 2021).
Although the use of ERCP in patients with choledocholithiasis is increasing, uncertainty remains as to whether single-stage or two-stage management provides better outcomes for patients.
A review of the available literature revealed a limited number of published studies on this method, even though it has been described and reported for several years.
In many published clinical cases, the detailed description and explanation of the laparoscopic transcystic papilla balloon dilation technique are lacking.
Therefore, it can be concluded that, to date, no standardized technique or protocol for the application of this method has been established. Several publications have retrospectively compared single-stage and two-stage treatment outcomes; however, a prospective, randomized study is needed for an in-depth analysis, as emphasized by other authors.
It is important to develop a safe and effective standardized technique and protocol for this method to facilitate its future use in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-step therapy method | Active comparator | Procedure: Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct., Procedure: Laparoscopic Cholecystectomy.Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct, and laparoscopic cholecystectomy (ERCP/LC). |
| The one-step therapy method | Sham comparator | Procedure: Laparoscopic transcystic balloon dilatation of the papilla Vateri.Laparoscopic cholecystectomy with intraoperative transcystic balloon dilatation of the papilla Vateri and anterograde evacuation of gallstones to duodenum (BD/LC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient older than 18 years,
- signed consent to participate in the study,
- diagnosed and confirmed choledocholithiasis,
- diameter of stones in the common bile duct no greater than 15 mm,
- patients whose general health condition will allow laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- patients under 18 years of age,
- patients who refused to sign a consent form to participate in the study,
- patients who, during conservative treatment (nitrates p/o), experience spontaneous antegrade evacuation of stones from the common bile duct,
- patients who have had a history of cholecystectomy,
- patients whose stone diameter in the common bile duct is greater 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct.Endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction is a minimally invasive endoscopic procedure used for the treatment of choledocholithiasis. The procedure is performed under sedation or general anesthesia with the patient in the prone or semi-prone position. A side-viewing duodenoscope is advanced into the duodenum, and the papilla of Vater is identified. The common bile duct is selectively cannulated using a guidewire-assisted technique, and contrast medium is injected under fluoroscopic control to visualize the biliary anatomy and confirm the presence of stones. If indicated, an endoscopic sphincterotomy is performed to enlarge the biliary orifice. Stones are then extracted using retrieval devices such as balloons or Dormia baskets, and complete duct clearance is confirmed by a final cholangiogram. A temporary biliary stent may be placed if drainage is inadequate. Patients are monitored after the procedure for potential complications. | Procedure or surgery | Two-step therapy method |
| Laparoscopic Cholecystectomy.Laparoscopic cholecystectomy is a minimally invasive surgical procedure for the removal of the gallbladder, typically indicated for symptomatic cholelithiasis or cholecystitis. The procedure is performed under general anesthesia. Four small trocars are inserted into the abdominal cavity to allow placement of a laparoscope and surgical instruments. The cystic duct and cystic artery are identified, clipped, and divided. The gallbladder is then dissected from the liver bed using electrocautery and removed through one of the port sites. After ensuring hemostasis and inspecting the operative field, the instruments are withdrawn, and the port sites are closed. Patients usually recover quickly, with a shorter hospital stay and reduced postoperative pain compared to open cholecystectomy. | Procedure or surgery | Two-step therapy method |
| Laparoscopic transcystic balloon dilatation of the papilla Vateri.Laparoscopic transcystic balloon dilatation of the papilla Vateri, performed during laparoscopic cholecystectomy, is a minimally invasive surgical technique. This technique involves the insertion of a balloon catheter through the cystic duct into the common bile duct, followed by inflation to dilate the papilla Vateri, facilitating stone passage into the duodenum. | Procedure or surgery | The one-step therapy method |
Primary outcome
Successful common bile duct clearance rate
Time frame: Immediately after surgery
Successful clearance of the common bile duct, defined as absence of residual stones confirmed intraoperatively by cholangiography, compared between the two treatment groups.
5 secondary outcomes
Length of hospital stay
Time frame: 7 days
Manipulation execution time
Time frame: Perioperatively. Unit of Measure: Minutes.
Frequency and types of complications
Time frame: From surgery through 10 to 30 days postoperatively
Technical success rate
Time frame: Immediately after surgery
Total hospital treatment cost.
Time frame: From enrollment to the end of treatment at 2 weeks
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 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct., Laparoscopic Cholecystectomy. and Laparoscopic transcystic balloon dilatation of the papilla Vateri. in people with Choledocholithiasis and Choledocholithiasis With Cholecystitis, run by Riga East Clinical University Hospital at 1 site in Latvia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 31 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 Latvia. 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. Some participants in this study may receive a placebo. 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?
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?
Successful common bile duct clearance rate (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.