Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

Conditions
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Pancreatic Neoplasms, Pancreatitis, Chronic

Intervention / Treatment
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* Procedure: Magnetic anastomosis for pancreaticojejunostomy
* Procedure: Traditional hand-sewn anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Magnetic group<br>Magnetic anastomosis for pancreaticojejunostomy | Procedure: Magnetic anastomosis for pancreaticojejunostomy<br>* Magnetic anastomosis for pancreaticojejunostomy<br>|
| Control group<br>Traditional hand-sewn for pancreaticojejunostomy | Procedure: Traditional hand-sewn anastomosis<br>* Traditional manual anastomosis for pancreaticojejunostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnamosis; magnetic anastomosis; pancreaticojejunostomy