Pancreatic Neoplasms, Pancreatitis, Chronic
Conditions
Keywords
magnamosis; magnetic anastomosis; pancreaticojejunostomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMagnetic anastomosis for pancreaticojejunostomy
Magnetic anastomosis for pancreaticojejunostomy
PROCEDURETraditional hand-sewn anastomosis
Traditional manual anastomosis for pancreaticojejunostomy
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy * Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure * Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy
Exclusion criteria
* Woman during pregnancy or lactation or anyone with mental disorder * The wall of pancreatic incision is too thick so that the attractive force of magnetic device cannot meet the requirements of compression * Any foreign body has been implanted in body, such as heart pacemaker. * Surgical contraindication, including Child-Pugh C with hepatic encephalopathy, and anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic fistula | From date of surgery to one month postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic stricture | one year from the date of surgery | Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations |
| Discharge of the magnets | 3 months from the date of surgery | X-ray plain film is performed regularly to check the movement and discharge of the magnets |
Countries
China
Contacts
Primary ContactLv Yi, MD, PhD
Backup ContactXu-Feng Zhang, MD, PhD
Outcome results
None listed