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

Overview

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.

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.