Pancreatic Cancer Clinical Trial
— BAMCTOfficial title:
Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | Health Science Center of Xi’an Jiaotong University, Northwest Institute for Non-ferrous Metal Research |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bilioenteric anastomotic leakage | To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis | 1 month post operation | |
Secondary | Length of bilioenteric anastomosis time | To compare the anastomotic time between magnetic and hand-sewn groups | during operation | |
Secondary | Time from the date of operation to expel of the magnets. | To confirm the safe discharge of the magnets | 1 to 4 weeks postoperation | |
Secondary | average length of postoperative hospital stay | To compare the length of stay between magnetic and hand-sewn groups | 3 months | |
Secondary | Bilioenteric anastomotic stricture | To compare the long-term outcome between magnetic and hand-sewn groups | 1,3,6,12-month post operation |
Status | Clinical Trial | Phase | |
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