- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03774589
Bilioenteric Anastomosis by Magnetic Compressive Technique (BAMCT)
Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xu-Feng Zhang, MD, PhD
- Phone Number: 86-29-85323626
- Email: xfzhang125@126.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Rongfeng Wang, MD
- Phone Number: 0086-15877553630
- Email: 15877553630@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
|
The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.
|
ACTIVE_COMPARATOR: Traditional Manual Anastomosis
A handsewn technique will be used during bilioenteric anastomosis.
|
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bilioenteric anastomotic leakage
Time Frame: 1 month post operation
|
To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis
|
1 month post operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of bilioenteric anastomosis time
Time Frame: during operation
|
To compare the anastomotic time between magnetic and hand-sewn groups
|
during operation
|
Time from the date of operation to expel of the magnets.
Time Frame: 1 to 4 weeks postoperation
|
To confirm the safe discharge of the magnets
|
1 to 4 weeks postoperation
|
average length of postoperative hospital stay
Time Frame: 3 months
|
To compare the length of stay between magnetic and hand-sewn groups
|
3 months
|
Bilioenteric anastomotic stricture
Time Frame: 1,3,6,12-month post operation
|
To compare the long-term outcome between magnetic and hand-sewn groups
|
1,3,6,12-month post operation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Cysts
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Gallbladder Diseases
- Biliary Tract Diseases
- Bile Duct Diseases
- Cholelithiasis
- Cholecystolithiasis
- Digestive System Abnormalities
- Cholangiocarcinoma
- Calculi
- Gallstones
- Choledochal Cyst
Other Study ID Numbers
- XJTU1AF-CRF-2015-001-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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