The RCT Study of Two Surgical Biliary-enteric Reconstruction Minimally Invasive Treatment of Bile Duct Dilatation
| Registry | NCT03401424 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Southwest Hospital, China (Other) |
| Conditions | Postcholecystectomy Syndrome |
| Interventions | improved Warren-type style, Roux-en-Y style (Procedure) |
| Dates | start 2017-06-01, primary completion 2019-06-01 (estimated), completion 2020-06-01 (estimated), first posted 2018-01-17, last updated 2018-01-17 |
| Locations | 1 site in China |
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All trials for Postcholecystectomy Syndrome All trials of improved Warren-type style All trials of Roux-en-Y style
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 .
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| improved Warren-type style | Experimental | Procedure: improved Warren-type style | Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy |
| Roux-en-Y style | Active comparator | Procedure: Roux-en-Y style | Early open cholecystectomy reconstruction surgery using Roux-en-Y style |
Sex: All, ages: 5 Years to 70 Years
Inclusion Criteria: 1. 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); 2. preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function 3. : Child-Pugh = B; 4. bile duct without canceration; 5. recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation; 6. the treatment of choledochal cyst, without any surgical treatment; 7. the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation; 8. voluntarily participated in the study, informed consent. Exclusion Criteria: 1. 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); 2. patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery; 3. bad general condition or heart pulmonary dysfunction cannot tolerate surgery; 4. severe cholestatic cirrhosis, severe portal hypertension; 5. high risk patients with general anesthesia.
| Facility | City | Country | Status |
|---|---|---|---|
| Southwest Hospital | Chongqing, Chongqing Municipality | China | Recruiting |