The Significance of Laparoscopic Transcystic Papilla Vateri Balloon Dilatation in Patients With Choledocholithiasis. (DILAILA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Choledocholithiasis; Choledocholithiasis With Cholecystitis
• Intervention / Treatment: Procedure: Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct.; Procedure: Laparoscopic Cholecystectomy.; Procedure: Laparoscopic transcystic balloon dilatation of the papilla Vateri.

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Latvia
  • Riga, Latvia, LV1038
    • Riga East Clinical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Two-step therapy method; Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct, and laparoscopic cholecystectomy (ERCP/LC).	Procedure: 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: 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.
Sham Comparator: The one-step therapy method; Laparoscopic cholecystectomy with intraoperative transcystic balloon dilatation of the papilla Vateri and anterograde evacuation of gallstones to duodenum (BD/LC).	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay measured as the number of days from the day of surgery to hospital discharge.	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.	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 (%).	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 (%)	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 (€)	From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

• Sponsor: Riga East Clinical University Hospital
• Collaborators: University of Latvia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Minimally invasive surgery; Choledocholithiasis; Gallstone disease; Transcystic papilla Vateri balloon dilation; Common bile duct exploration; Complicated gallstone disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Choledocholithiasis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Diagnostic Imaging; Radiography; Biliary Tract Surgical Procedures; Laparoscopy; Cholecystectomy; Cholangiography; Radiography, Abdominal; Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde
• Other Study ID Numbers: 06-A/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No