Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis (MCTPIA)

Xi'an Jiaotong University

Status: Unknown

Conditions: Pancreatitis, Chronic; Pancreatic Neoplasms

Treatments: Procedure: Traditional hand-sewn anastomosis; Procedure: Magnetic anastomosis for pancreaticojejunostomy

Study type: Observational

Funder types: Other

Identifiers

NCT03780946

XJTU1AF-CRF-2015-001-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Magnetic group

Description:

Magnetic anastomosis for pancreaticojejunostomy

Treatment:

Procedure: Magnetic anastomosis for pancreaticojejunostomy

Control group

Description:

Traditional hand-sewn for pancreaticojejunostomy

Treatment:

Procedure: Traditional hand-sewn anastomosis