Bilioenteric Anastomosis by Magnetic Compressive Technique (BAMCT)
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|ClinicalTrials.gov Identifier: NCT03774589|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Cholangiocarcinoma Bile Duct Injury Choledochal Cyst Biliary Calculi||Procedure: Magnetic Compressive Anastomosis Procedure: Manual Anastomosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Procedure: Magnetic Compressive 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.
Procedure: Manual Anastomosis
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
- Bilioenteric anastomotic leakage [ Time Frame: 1 month post operation ]To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis
- Length of bilioenteric anastomosis time [ Time Frame: during operation ]To compare the anastomotic time between magnetic and hand-sewn groups
- 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
- average length of postoperative hospital stay [ Time Frame: 3 months ]To compare the length of stay between magnetic and hand-sewn groups
- Bilioenteric anastomotic stricture [ Time Frame: 1,3,6,12-month post operation ]To compare the long-term outcome between magnetic and hand-sewn groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774589
|Contact: Yi Lv, MD,PHDemail@example.com|
|Contact: Xu-Feng Zhang, MD, PhDfirstname.lastname@example.org|
|Principal Investigator:||Yi Lv, MD,PHD||China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity|