Back to resultsComparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia
Primary Purpose
Postcholecystectomy Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
improved Warren-type style
Roux-en-Y style
Sponsored by
About this trial
This is an interventional treatment trial for Postcholecystectomy Syndrome focused on measuring congenital cyst of common bile duct, Biliary enteric anastomosis
Eligibility Criteria
Inclusion Criteria:
- 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);
- preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function
- : Child-Pugh = B;
- bile duct without canceration;
- recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation;
- the treatment of choledochal cyst, without any surgical treatment;
- the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation;
- voluntarily participated in the study, informed consent.
Exclusion Criteria:
- 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);
- patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery;
- bad general condition or heart pulmonary dysfunction cannot tolerate surgery;
- severe cholestatic cirrhosis, severe portal hypertension;
- high risk patients with general anesthesia.
Sites / Locations
- Southwest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
improved Warren-type style
Roux-en-Y style
Arm Description
Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy
Early open cholecystectomy reconstruction surgery using Roux-en-Y style
Outcomes
Primary Outcome Measures
operation time
Two surgical methods operation time
Secondary Outcome Measures
Full Information
NCT ID
NCT03401424
First Posted
December 28, 2017
Last Updated
January 15, 2018
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03401424
Brief Title
Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia
Official Title
The RCT Study of Two Surgical Biliary-enteric Reconstruction Minimally Invasive Treatment of Bile Duct Dilatation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postcholecystectomy Syndrome
Keywords
congenital cyst of common bile duct, Biliary enteric anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
improved Warren-type style
Arm Type
Experimental
Arm Description
Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy
Arm Title
Roux-en-Y style
Arm Type
Active Comparator
Arm Description
Early open cholecystectomy reconstruction surgery using Roux-en-Y style
Intervention Type
Procedure
Intervention Name(s)
improved Warren-type style
Intervention Description
Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y style
Intervention Description
Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.
Primary Outcome Measure Information:
Title
operation time
Description
Two surgical methods operation time
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function
: Child-Pugh = B;
bile duct without canceration;
recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation;
the treatment of choledochal cyst, without any surgical treatment;
the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation;
voluntarily participated in the study, informed consent.
Exclusion Criteria:
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);
patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery;
bad general condition or heart pulmonary dysfunction cannot tolerate surgery;
severe cholestatic cirrhosis, severe portal hypertension;
high risk patients with general anesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuguo Zheng
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng
Organizational Affiliation
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng, Professor
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia
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