TrialReader


Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

NCT03401424 — Not applicable, Unknown, 120 participants, Southwest Hospital, China

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT03401424
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment120 (Estimated)
SponsorSouthwest Hospital, China (Other)
ConditionsPostcholecystectomy Syndrome
Interventionsimproved Warren-type style, Roux-en-Y style (Procedure)
Datesstart 2017-06-01, primary completion 2019-06-01 (estimated), completion 2020-06-01 (estimated), first posted 2018-01-17, last updated 2018-01-17
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Postcholecystectomy Syndrome All trials of improved Warren-type style All trials of Roux-en-Y style

-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 .

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
improved Warren-type styleExperimentalProcedure: improved Warren-type styleMinimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy
Roux-en-Y styleActive comparatorProcedure: Roux-en-Y styleEarly open cholecystectomy reconstruction surgery using Roux-en-Y style
  • improved Warren-type style (Procedure): Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.
  • Roux-en-Y style (Procedure): Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.

+Outcome measures

Primary outcomes

  • operation time [2 years]: Two surgical methods operation time

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Southwest HospitalChongqing, Chongqing MunicipalityChinaRecruiting

+Investigators

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

My Notes