Superior Bilioenteric Anastomosis by Magnetic Compressive Technique (CTREG)
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|ClinicalTrials.gov Identifier: NCT02801500|
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hilar Cholangiocarcinoma Bile Duct Injury Choledochal Cyst Biliary Calculi||Device: Magnetic Compressive Anastomosis Procedure: Manual Anastomosis||Not Applicable|
The superior bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.
This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Device: Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device 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 ]
- Length of bilioenteric anastomosis time [ Time Frame: during operation ]
- Number of patients who have discharged the device on the date expected. [ Time Frame: 1 to 4 weeks postoperation ]
- Number of patients who have been diagnosed as discharge disorder of magnetic device [ Time Frame: less than 1 week or more than 4 weeks ]
- average length of postoperative hospital stay [ Time Frame: 3 months ]
- Times of pathological examination of bile duct's remnant of Klatskin' tumor [ Time Frame: during operation ]
- Bilioenteric anastomotic stricture [ Time Frame: Time Frame: 1,3,6,12-month post operation ]
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): NCT02801500
|Contact: Yi Lv, MD,PHDemail@example.com|
|First Affiliated Hospital of Xian JiaotongUniversity||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Yi Lv, MD，PHD 0086-13991200581 firstname.lastname@example.org|
|The First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Xiaopeng Yan, PHD 08615332432878 email@example.com|