Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

Pancreatic Neoplasms Clinical Trial

— MCTPIA  

Official title:

Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780946
• Other study ID #: XJTU1AF-CRF-2015-001-3
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Lv Yi, MD, PhD
• Phone: 86-29-85323900
• Email: luyi169[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• Magnetic anastomosis for pancreaticojejunostomy
Magnetic anastomosis for pancreaticojejunostomy
• Traditional hand-sewn anastomosis
Traditional manual anastomosis for pancreaticojejunostomy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anastomotic stricture	Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations	one year from the date of surgery
Secondary	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