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Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC after ERCP. Given the inflammation of the gallbladder and the inflammatory process in the hepatoduodenal ligament, early laparoscopic cholecystectomy can lead to various intraoperative complications. The aim of this retrospective study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).
There is no gold standard for the treatment of cholecystocholedocholithiasis in the pediatric population. The most common method for resolving biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). There are different approaches to the treatment of cholecystocholedocholithiasis: 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, many medical institutions do not have the opportunity to use these methods due to the difficulties of implementation and the need for specialized training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis remains a subject of debate. The present study aims to compare ERCP with ES + delayed LC in intra- and re-hospitalization in pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP, EST and LC in one hospitalization |
| ||
| ERCP, EST and LC on rehospitalization |
|
| 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 on a delayed basis, 7 to 15 days after ERCP in a single hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of common bile duct stones | The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy. | 60 days after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | 30 days after ERCP | |
| Perforation | by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination) | 30 days after ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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children under 18 years of age diagnosed with cholecystocholedocholithiasis
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| Name | Affiliation | Role |
|---|---|---|
| Dmitriy А Pyhteev, PhD | Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky | 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 for readmission, 1 month after ERCP under general anesthesia. |
|
| 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 |
| Acute pancreatitis | at least two out of three criteria according to the classification developed by the INSPPIRE group | 30 days after ERCP |
| Duration of the laparoscopic cholecystectomy,min | From enrollment to the end of treatment (3 month) |
| Duration of the Endoscopic retrograde cholangiopancreatography,min | From enrollment to the end of treatment (3 month) |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D041761 | Cholecystolithiasis |
| 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 |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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