Status:
UNKNOWN
Bilioenteric Anastomosis by Magnetic Compressive Technique
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
Xi'an Jiaotong University
Northwest Institute for Non-ferrous Metal Research
Conditions:
Pancreatic Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
Detailed Description
The bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the...
Eligibility Criteria
Inclusion
- Patients with age between 18 to 75
- Patients' gender was not limited
- Patients who were well-diagnosed and had the indication for bilioenteric anastomosis.
- Patients whose lifetimes will be longer than 12 months.
- Patients who are willing to join this clinical trial and informed consent form voluntarily.
Exclusion
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of hepatic duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including:
- Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
- • Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03774589
Start Date
February 1 2019
End Date
January 31 2022
Last Update
November 18 2019
Active Locations (1)
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1
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061