Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

NCT ID: NCT03401424

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-06-01

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.

Conditions

Postcholecystectomy Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

improved Warren-type style

Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy

Group Type: EXPERIMENTAL

improved Warren-type style

Intervention Type: PROCEDURE

Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.

Roux-en-Y style

Early open cholecystectomy reconstruction surgery using Roux-en-Y style

Group Type: ACTIVE_COMPARATOR

Roux-en-Y style

Intervention Type: PROCEDURE

Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.

Interventions

improved Warren-type style

Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.

Intervention Type: PROCEDURE

Roux-en-Y style

Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Shuguo Zheng, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuguo Zheng

Role: STUDY_DIRECTOR

Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuguo Zheng

Role: CONTACT

shuguozh@yahoo.com.cn

0086-13508308676

Facility Contacts

Shuguo Zheng, Professor

Role: primary

shuguozh@yahoo.com.cn

0086-13508308676

Other Identifiers

Zhengshuguo

Identifier Type: REGISTRY

Identifier Source: secondary_id

SWHZSG008

Identifier Type: -

Identifier Source: org_study_id