Status:
UNKNOWN
Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Cholangiocarcinoma
Pancreatic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostom...
Detailed Description
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage be...
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 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 biliary 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 :
50 Patients enrolled
Trial Details
Trial ID
NCT03792048
Start Date
February 1 2019
End Date
January 31 2022
Last Update
November 18 2019
Active Locations (2)
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1
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, China, 710061
2
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061