scholarly journals Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Diagnostic Randomized Trial

2020 ◽  
Author(s):  
Ausra Aleknaite ◽  
Gintaras Simutis ◽  
Juozas Stanaitis ◽  
Tomas Jucaitis ◽  
Mantas Drungilas ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Endoscopic Ultrasound ◽  
Management Strategies ◽  
Endoscopic Retrograde Cholangiography ◽  
Intraoperative Cholangiography ◽  
Intermediate Risk ◽  
Endoscopic Retrograde ◽  
On Demand ◽  
Gallbladder Stones

Abstract Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. Methods: It is a diagnostic randomized active-controlled single-centre clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. Discussion: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. Trial registration: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

scholarly journals Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Randomized Trial

2019 ◽  
Author(s):  
Ausra Aleknaite ◽  
Gintaras Simutis ◽  
Juozas Stanaitis ◽  
Tomas Jucaitis ◽  
Mantas Drungilas ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Endoscopic Ultrasound ◽  
Management Strategies ◽  
Endoscopic Retrograde Cholangiography ◽  
Intraoperative Cholangiography ◽  
Intermediate Risk ◽  
Endoscopic Retrograde ◽  
On Demand ◽  
Gallbladder Stones

Abstract Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. • Methods: It is a prospective randomized single-centre clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. • Discussion: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. • Trial registration: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

scholarly journals Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Diagnostic Randomized Trial (Preprint)

2020 ◽  
Author(s):  
Ausra Aleknaite ◽  
Gintaras Simutis ◽  
Juozas Stanaitis ◽  
Tomas Jucaitis ◽  
Mantas Drungilas ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Endoscopic Ultrasound ◽  
Management Strategies ◽  
Endoscopic Retrograde Cholangiography ◽  
Intraoperative Cholangiography ◽  
Intermediate Risk ◽  
Endoscopic Retrograde ◽  
On Demand ◽  
Gallbladder Stones

BACKGROUND The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. OBJECTIVE This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. METHODS It is a diagnostic randomized active-controlled single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. RESULTS The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. CONCLUSIONS This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. CLINICALTRIAL The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

scholarly journals Endoscopic ultrasound versus endoscopic retrograde cholangiography for the diagnosis of choledocholithiasis: the influence of the size of the stone and diameter of the common bile duct

2005 ◽  
Vol 42 (4) ◽  
pp. 239-243 ◽  
Author(s):  
Marcus Vinicius Silva Ney ◽  
Fauze Maluf-Filho ◽  
Paulo Sakai ◽  
Bruno Zilberstein ◽  
Joaquim Gama-Rodrigues ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Bile Duct ◽  
Common Bile Duct ◽  
Endoscopic Ultrasound ◽  
Common Bile Duct Stones ◽  
Endoscopic Retrograde Cholangiography ◽  
Bile Duct Stones ◽  
Endoscopic Retrograde ◽  
The Common ◽  
Common Bile Duct Diameter

BACKGROUND: Endoscopic retrograde cholangiography is highly accurate in diagnosing choledocholithiasis, but it is the most invasive of the available methods. Endoscopic ultrasonography is a very accurate test for the diagnosis of choledocholithiasis with a risk of complications similar to that of upper gastrointestinal endoscopy. AIM: To compare the accuracy of endoscopic ultrassonography and endoscopic retrograde cholangiography in the diagnosis of common bile duct stones before laparoscopic cholecystectomy and to analyze endoscopic ultrasound results according to stone size and common bile duct diameter. PATIENTS AND METHODS: Two hundred and fifteen patients with symptomatic gallstones were admitted for laparoscopic cholecystectomy. Sixty-eight of them (31.7%) had a dilated common bile duct and/or hepatic biochemical parameter abnormalities. They were submitted to endoscopic ultrassonography and endoscopic retrograde cholangiography. Sphincterotomy and sweeping of the common bile duct were performed if endoscopic ultrassonography or endoscopic retrograde cholangiography were considered positive for choledocholithiasis. After sphincterotomy and common bile duct clearance the largest stone was retrieved for measurement. Endoscopic or surgical explorations of the common bile duct were considered the gold-standard methods for the diagnosis of choledocholithiasis. RESULTS: All 68 patients were submitted to laparoscopic cholecystectomy with intraoperative cholangiography with confirmation of the presence of gallstones. Endoscopic ultrassonography was a more sensitivity test than endoscopic retrograde cholangiography (97% vs. 67%) for the detection of choledocholithiasis. When stones >4.0 mm were analyzed, endoscopic ultrassonography and endoscopic retrograde cholangiography presented similar results (96% vs. 90%). Neither the size of the stone nor the common bile duct diameter had influence on endoscopic ultrasonographic performance. CONCLUSIONS: For a group of patients with an intermediate or moderate risk with respect to the likelihood of having common bile duct stones, endoscopic ultrassonography is a better test for the diagnosis of choledocholithiasis when compared to endoscopic retrograde cholangiography mainly for small-sized calculi.

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