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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic group | Magnetic anastomosis for pancreaticojejunostomy |
| |
| Control group | Traditional hand-sewn for pancreaticojejunostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic anastomosis for pancreaticojejunostomy | Procedure | Magnetic anastomosis for pancreaticojejunostomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lv Yi, MD, PhD | Contact | 86-29-85323900 | luyi169@126.com | |
| Xu-Feng Zhang, MD, PhD | Contact | 86-29-85323626 | xfzhang125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Lv, MD, PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D010193 | Pancreaticojejunostomy |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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| Traditional hand-sewn anastomosis | Procedure | Traditional manual anastomosis for pancreaticojejunostomy |
|
| 3 months from the date of surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |