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

NCT07503964 | Active Not Recruiting

• 1 other identifier: 06-A/25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Choledocholithiasis; Choledocholithiasis With Cholecystitis

Keywords

Laparoscopic cholecystectomy; Choledocholithiasis; Transcystic papilla Vateri balloon dilation; Gallstone disease; Minimally invasive surgery; Common bile duct exploration; Complicated gallstone disease

Outcome Measures

Primary Outcomes (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.

  Immediately after surgery

Secondary Outcomes (5)

• Length of hospital stay

  7 days

• Manipulation execution time

  Perioperatively. Unit of Measure: Minutes.

• Frequency and types of complications

  From surgery through 10 to 30 days postoperatively

• Technical success rate

  Immediately after surgery

• Total hospital treatment cost.

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Two-step therapy method

ACTIVE COMPARATOR

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.; 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).

Procedure: Laparoscopic transcystic balloon dilatation of the papilla Vateri.

Interventions

Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct. PROCEDURE

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.

Two-step therapy method

Laparoscopic Cholecystectomy. PROCEDURE

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.

Two-step therapy method

Laparoscopic transcystic balloon dilatation of the papilla Vateri. PROCEDURE

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.

The one-step therapy method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riga East Clinical University Hospital: lead
• University of Latvia: collaborator

Study Sites (1)

Riga East Clinical University Hospital

Riga, LV1038, Latvia

Location

MeSH Terms

Conditions

Choledocholithiasis; Cholelithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cholecystectomy; Biliary Tract Surgical Procedures; Laparoscopy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: March 31, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

LA (1)