Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study was to design a prospective and case-control study with utilization of magnetic compression anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to assess the safety and formation of the anastomosis by magnetic technique.
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas for pancreaticojejunostomy, smaller magnets are routinely used. This study is a single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy time, discharge rule of the magnets will be all evaluated in the current study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGIncidence of anastomotic fistula
Incidence of biliary or pancreatic fistula after surgery
Time frame: 1 month post operation
Length of bilio-/pancreaticojejunostomy time
Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
Time frame: during operation
average length of postoperative hospital stay
length of hospital stay (days) after surgery
Time frame: 1 to 4 weeks postoperation
Hospitalization cost
cost in hospital
Time frame: 1 to 4 weeks postoperation
incidence of biliojejunostomic stricture
Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Time frame: 12 months post operation
Incidence of pancreaticojejunostomic stricture
Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Time frame: 12 months post operation
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