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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( laparoscopic cholecystectomy) after ERCP( endoscopic retrograde cholangiopancreatography).
The aim of this prospective study is to evaluate the efficacy and safety Laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis.
The incidence of concomitant choledocholithiasis in patients with gallstone disease has been reported to range between 10% and 20% depending on geographic distribution.The ideal management of cholecysto-choledocholithiasis is still a matter of debate; different modalities, including the open and the laparoscopic approach, and sequential or simultaneous techniques, have been applied with success.
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD( common bile duct) stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).
The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification.
Aim of the study is to evaluate use of laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis using preprocedural abdominal CT findings. Primary outcome is to performs difficult biliary cannulation by rendezvous technique while secondary outcomes is to to detect morbidity (especially post-ERCP pancreatitis) , success of CBD clearance and to detect overall hospital
Risk factors of difficult cannulation during ERCP based on preprocedural abdominal CT findings in the study :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoendoscopic rendezvous(LERV) | Other | Step 1: Laparoscopic Phase Step 2: Endoscopic Phase Step 3: Completion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoendoscopic rendezvous | Procedure | The main principles of LERV technique consists of
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the success rate of LERV for difficult cannulation | Assess the success rate of LERV for difficult cannulation | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis | CBD clearance success,Complete extraction of all stones during LERV judged by ERCP imaging | intraoperative |
| incidence of postsphincterotomy bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saleh K Saleh, MD | Contact | 01201765401 | +2 | salehkhairy@mu.edu.eg |
| Ayman M Hassanen, MD | Contact | 0 109 275 8555 | +2 | Ayman.hassan@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and GIT hospital , Minia University | Recruiting | Minya | 61519 | Egypt |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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|
obvious bleeding during ERCP Or delayed as melena |
| 30 days after LERV |
| incidence of Acute pancreatitis | increase serum amylase and lipase | 30 days after ERCP |
| Recurrence of common bile duct stones | The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound. | 60 days after LERV |
| Incidence of bile leak | bile aspirated from the abdominal cavity | 30 days after LERV |
| incidence of Perforation | by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination) | 30 days after LERV |
| incidence of Acute cholangitis | intermittent chills, fever, increased proinflammatory blood markers after ERCP | 60 days after LERV |
| incidence of bile duct stricture | after LERV | 1 year after LERV |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |