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Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03401424
Enrollment
120
Registered
2018-01-17
Start date
2017-06-01
Completion date
2020-06-01
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postcholecystectomy Syndrome

Keywords

congenital cyst of common bile duct, Biliary enteric anastomosis

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.

Interventions

PROCEDUREimproved Warren-type style

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

PROCEDURERoux-en-Y style

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

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
operation time2 yearsTwo surgical methods operation time

Countries

China

Contacts

Primary ContactShuguo Zheng
shuguozh@yahoo.com.cn0086-13508308676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026