Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

Postcholecystectomy Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03401424
• Other study ID #: SWHZSG008
• Secondary ID: Zhengshuguo
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 15, 2018
• Start date: June 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2018
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng
• Phone: 0086-13508308676
• Email: shuguozh[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postcholecystectomy Syndrome

Intervention

Procedure:
• improved Warren-type style
Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.
• Roux-en-Y style
Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	Two surgical methods operation time	2 years