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2019-02-01
2021-01-31
2022-01-31
200
NCT03774589
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
INTERVENTIONAL
Bilioenteric Anastomosis by Magnetic Compressive Technique
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
The 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. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-12-12 | N/A | 2019-11-15 |
2018-12-12 | N/A | 2019-11-18 |
2018-12-13 | N/A | 2019-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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. | PROCEDURE: Magnetic Compressive Anastomosis
|
| ACTIVE_COMPARATOR: Traditional Manual Anastomosis A handsewn technique will be used during bilioenteric anastomosis. | PROCEDURE: Manual Anastomosis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Bilioenteric anastomotic leakage | To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis | 1 month post operation |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Length of bilioenteric anastomosis time | To compare the anastomotic time between magnetic and hand-sewn groups | during operation |
| Time from the date of operation to expel of the magnets. | To confirm the safe discharge of the magnets | 1 to 4 weeks postoperation |
| average length of postoperative hospital stay | To compare the length of stay between magnetic and hand-sewn groups | 3 months |
| Bilioenteric anastomotic stricture | To compare the long-term outcome between magnetic and hand-sewn groups | 1,3,6,12-month post operation |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Yi Lv, MD,PHD Phone Number: 86-29-85323900 Email: luyi169@126.com |
Study Contact Backup Name: Xu-Feng Zhang, MD, PhD Phone Number: 86-29-85323626 Email: xfzhang125@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
