NCT03401424

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

December 28, 2017

Last Update Submit

January 15, 2018

Conditions

Postcholecystectomy Syndrome

Keywords

congenital cyst of common bile ductBiliary enteric anastomosis

Outcome Measures

Primary Outcomes (1)

  • operation time

    Two surgical methods operation time

    2 years

Study Arms (2)

improved Warren-type style

EXPERIMENTAL

Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy

Procedure: improved Warren-type style

Roux-en-Y style

ACTIVE COMPARATOR

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

Procedure: Roux-en-Y style

Interventions

improved Warren-type stylePROCEDURE

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

improved Warren-type style
Roux-en-Y stylePROCEDURE

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

Roux-en-Y style

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Postcholecystectomy Syndrome

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shuguo Zheng

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

    STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng

CONTACT

0086-13508308676shuguozh@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 17, 2018

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)