Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

Not Applicable

• Conditions: Postcholecystectomy Syndrome
• Interventions: Procedure: Roux-en-Y style; Procedure: improved Warren-type style

• Registration Number: NCT03401424
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-15
• Last Update Submitted: 2018-01-15
• Study First Posted: 2018-01-17
• Last Update Posted: 2018-01-17
• Primary Completion: 2019-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en-Y style	Roux-en-Y style	Early open cholecystectomy reconstruction surgery using Roux-en-Y style
improved Warren-type style	improved Warren-type style	Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy

Primary Outcome Measures

Name	Time	Method
operation time	2 years	Two surgical methods operation time

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China