Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Moscow, Moscow Oblast, 142636, Russia
NCT Number: NCT06676241
In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
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Notify Me0 year–80 year
All sexes
Observational
Moscow, Moscow Oblast, 142636, Russia
Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and LC after ERCP. Both LCBDE and LERV allow for the simultaneous treatment of cholecystocholedocholithiasis. However, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia.
Other names: Cholangiopancreatography, Laparoscopic
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patient underwent the endoscopic procedure using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis no earlier than 7 days after ERCP
Other names: Cholangiopancreatography, Laparoscopic
Time frame: 30 days after ERCP
The diagnosis of the stone in the common bile duct.
Time frame: 30 days after ERCP
decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood
Time frame: 30 days after ERCP
by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Time frame: 30 days after ERCP
bile aspirated from the abdominal cavity
Time frame: 60 days after ERCP
intermittent chills, fever, increased proinflammatory blood markers after ERCP
Time frame: 1 year after ERCP
after ERCP
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Time frame: 1 month
Time frame: From enrollment to the end of treatment (3 month)
Time frame: within 14 days after ERCP
at least two out of three criteria according to the classification developed by the INSPPIRE group
Time frame: From enrollment to the end of treatment (3 month)
Moscow Regional Research and Clinical Institute (MONIKI)
Other Gov
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