An interventional study of Endoscopic retrograde cholangiopancreatography with papillotomy and stone evacuation from common bile duct. and Laparoscopic Cholecystectomy. in Choledocholithiasis and Choledocholithiasis With Cholecystitis, sponsored by Riga East Clinical University Hospital. Active, not recruiting at 1 site in Latvia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Riga East Clinical University Hospital · Not applicable, Interventional, and Treatment
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):
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Riga East Clinical University Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
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 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, 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.
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.
Time frame: Immediately after surgery
Length of hospital stay
Length of hospital stay measured as the number of days from the day of surgery to hospital discharge.
Time frame: 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.
Time frame: 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 (%).
Time frame: 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 (%)
Time frame: 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 (€)
Time frame: From enrollment to the end of treatment at 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Oct 2027, 29 months after the start.
Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 29 months is above that.
Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Riga East Clinical University Hospital