Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

• Conditions: Pancreatitis, Chronic; Pancreatic Neoplasms
• Interventions: Procedure: Traditional hand-sewn anastomosis; Procedure: Magnetic anastomosis for pancreaticojejunostomy

• Registration Number: NCT03780946
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-02-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-10
• Last Update Posted: 2019-11-13
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Traditional hand-sewn anastomosis	Traditional hand-sewn for pancreaticojejunostomy
Magnetic group	Magnetic anastomosis for pancreaticojejunostomy	Magnetic anastomosis for pancreaticojejunostomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China