Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure

Cholangiocarcinoma Clinical Trial

Official title:

Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792048
• Other study ID #: XJTU1AF-CRF-2015-001-2
• Status: Recruiting
• Phase: N/A
• 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: Yi Lv, MD,PHD
• Phone: 0086-13991200581
• Email: luyi169[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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 75 Years

Eligibility

Inclusion Criteria:

• Patients with age between 18 to 75

• Patients' gender was not limited

• Patients who were well-diagnosed and had the indication for anastomosis.

• Patients whose lifetimes will be longer than 12 months.

• Patients who are willing to join this clinical trial and informed consent form voluntarily.

Exclusion Criteria:

• Woman during pregnancy or lactation or anyone with mental disorder

• The wall of biliary duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.

• Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.

• Any foreign body has been implanted in body, such as heart pacemaker.

• Surgical contraindication, including:

Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long-term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.

-Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Chronic Pancreatitis
• Duodenal Neoplasms
• Neoplasms
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Pancreatolithiasis

Intervention

Procedure:
• Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi
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	Incidence of anastomotic fistula	Incidence of biliary or pancreatic fistula after surgery	1 month post operation
Secondary	Length of bilio-/pancreaticojejunostomy time	Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy	during operation
Secondary	average length of postoperative hospital stay	length of hospital stay (days) after surgery	1 to 4 weeks postoperation
Secondary	Hospitalization cost	cost in hospital	1 to 4 weeks postoperation
Secondary	incidence of biliojejunostomic stricture	Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up	12 months post operation
Secondary	Incidence of pancreaticojejunostomic stricture	Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up	12 months post operation