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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP, EST and simultaneous LC | Patients aged 10-80 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia |
| |
| ERCP, EST and LC in a delayed manner | Patients aged 0-17 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed in a delayed manner, not earlier than 7 days after ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of stones in the common bile duct | The diagnosis of the stone in the common bile duct. | 30 days after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood | 30 days after ERCP |
| Perforation | by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination) |
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Inclusion Criteria:
Exclusion Criteria:
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Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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| Name | Affiliation | Role |
|---|---|---|
| Dmitriy А Pyhteev, PhD | Head of the Department of Pediatric Surgery | Study Director |
| Leonid M Elin | Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky | Moscow | Moscow Oblast | 142636 | Russia |
A complete dataset can be provided upon reasoned request
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|
|
| endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy | Procedure | 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 |
|
|
| 30 days after ERCP |
| Bile leak | bile aspirated from the abdominal cavity | 30 days after ERCP |
| Acute cholangitis | intermittent chills, fever, increased proinflammatory blood markers after ERCP | 60 days after ERCP |
| Bile duct stricture | after ERCP | 1 year after ERCP |
| Time spent in hospital until discharge | from admission to hospital until the end of treatment (up to 8 weeks) |
| Technical success - success of the procedures as documented by a yes or no | 1 month |
| Duration of the laparoscopic cholecystectomy,min | From enrollment to the end of treatment (3 month) |
| Acute pancreatitis | at least two out of three criteria according to the classification developed by the INSPPIRE group | within 14 days after ERCP |
| Duration of the Endoscopic retrograde cholangiopancreatography | From enrollment to the end of treatment (3 month) |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D041761 | Cholecystolithiasis |
| D010195 | Pancreatitis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
| D005705 | Gallbladder Diseases |
| D010182 | Pancreatic Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D017081 | Cholecystectomy, Laparoscopic |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
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