Bilioenteric Anastomosis by Magnetic Compressive Technique (NCT03774589) | Clinical Trial Compass
UnknownNot Applicable
Bilioenteric Anastomosis by Magnetic Compressive Technique
China200 participantsStarted 2019-02-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Bilioenteric anastomotic leakage
Timeframe: 1 month post operation
Trial details
NCT IDNCT03774589
SponsorFirst Affiliated Hospital Xi'an Jiaotong University