CClinicalTrials.gg
Status unknownNCT03401424Updated Jan 17, 2018

Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

An interventional study of improved Warren-type style and Roux-en-Y style in Postcholecystectomy Syndrome, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
5 Years to 70 Years
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Postcholecystectomy Syndrome

Keywords

  • congenital cyst of common bile duct
  • Biliary enteric anastomosis
03

Who can participate

Ages eligible
5 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    improved Warren-type style

    Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy

    Procedure: improved Warren-type style

  • Active comparator
    Roux-en-Y style

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

    Procedure: Roux-en-Y style

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.

05

What researchers measure

Primary outcomes

  1. operation time

    Two surgical methods operation time

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
    • Shuguo Zheng, Professor · Contact · shuguozh@yahoo.com.cn · 0086-13508308676
    • Shuguo Zheng · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03401424
Lead sponsor
Southwest Hospital, China
Responsible party
Shuguo Zheng, MD (Professor, Southwest Hospital, China) — Principal investigator
First posted
Jan 17, 2018
Start date
Jun 1, 2017
Primary completion
Jun 1, 2019 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
Jan 17, 2018

Study contacts

Shuguo Zheng
Contact
shuguozh@yahoo.com.cn
0086-13508308676
Shuguo Zheng
study director · Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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