Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

Study Overview
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Brief Summary
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To observe and compare the short-term and long-term effects of different biliary and intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile duct .

Detailed Description
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The purpose of the study： length of operation time, postoperative intestinal function recovery time as the main index, application prospective clinical study to observe the differences were followed by two different laparoscopic biliary intestinal kiss the short-term and long-term effect of the treatment of congenital cystic dilatation of the bile duct, provide a higher level of evidence based medicine dilatation of patients for congenital bile duct cysts. The choice of second is based on the study, effective, objective evaluation of different laparoscopic biliary enteric reconstruction for the treatment of congenital cystic dilatation of the bile duct is feasible, clear surgical indications, contraindications and summarized the technical points, establish guidelines for clinical diagnosis and treatment of congenital cystic dilation of the bile duct disease.

Official Title
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The RCT Study of Two Surgical Biliary-enteric Reconstruction Minimally Invasive Treatment of Bile Duct Dilatation

Conditions
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Postcholecystectomy Syndrome

Intervention / Treatment
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* Procedure: improved Warren-type style
* Procedure: Roux-en-Y style


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gender, age 5-70 years old (the disease can occur at any age, but in 80% cases of childhood onset, such as children's height and weight of endoscopic treatment for the standard, by parents as guardians into the group); preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function : Child-Pugh = B; bile duct without canceration; recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation; the treatment of choledochal cyst, without any surgical treatment; the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation; voluntarily participated in the study, informed consent. Exclusion Criteria: congenital cystic dilatation of the bile duct of III type, V type (III type feasible endoscope end of bile duct duodenal sphincterotomy, V type partial resection of the liver); patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery; bad general condition or heart pulmonary dysfunction cannot tolerate surgery; severe cholestatic cirrhosis, severe portal hypertension; high risk patients with general anesthesia.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: improved Warren-type style<br>Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy | Procedure: improved Warren-type style<br>* Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.<br>|
| Active Comparator: Roux-en-Y style<br>Early open cholecystectomy reconstruction surgery using Roux-en-Y style | Procedure: Roux-en-Y style<br>* Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | Two surgical methods operation time | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital cyst of common bile duct, Biliary enteric anastomosis