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The Significance of Laparoscopic Transcystic Papilla Vateri Balloon Dilatation in Patients With Choledocholithiasis.
Sponsor: Riga East Clinical University Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-05-01
Completion Date
2028-10-01
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
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.
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.
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.
Locations (1)
Riga East Clinical University Hospital
Riga, Latvia