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2019-02-01
2021-01-31
2022-01-31
50
NCT03780946
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
OBSERVATIONAL
Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis
In recent five years, the investigators have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
Magnetic anastomosis has been attempted in continuous connection between bowel and bowel, vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the biliary stricture, and bilioenteric anastomotic stricture. During the past 15 years, the investigators have designed different types of magnets, and attempted these magnets in vascular, intestine, and biliary anastomosis in preclinical studies. In recent five years, we have successfully developed different types of magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is designed as a prospective study by utilization of the bar-like magnets for pancreaticojejunostomy.
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 | 2019-11-10 |
2018-12-17 | N/A | 2019-11-13 |
2018-12-19 | 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:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Magnetic group Magnetic anastomosis for pancreaticojejunostomy | PROCEDURE: Magnetic anastomosis for pancreaticojejunostomy
|
| : Control group Traditional hand-sewn for pancreaticojejunostomy | PROCEDURE: Traditional hand-sewn anastomosis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pancreatic fistula | Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity. | From date of surgery to one month postoperatively |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Anastomotic stricture | Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations | one year from the date of surgery |
| Discharge of the magnets | X-ray plain film is performed regularly to check the movement and discharge of the magnets | 3 months from the date of surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Lv Yi, 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
