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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Latvia1 site
  • Riga East Clinical University Hospital

    Riga, LV1038

Other trials in Latvia

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):

  1. The method is relatively fast;
  2. It is a single-stage procedure;
  3. It is safe and associated with a low rate of complications;
  4. 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 groups in NCT07503964
Study groupRoleWhat they receive
Two-step therapy methodActive comparatorEndoscopic 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 methodSham comparatorLaparoscopic 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.

  1. 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)
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  1. First posted31 Mar 2026
  2. Study start1 May 2025
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

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)
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

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.

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