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

Not Applicable

• Conditions: Duodenal Neoplasms; Chronic Pancreatitis; Cholangiocarcinoma; Pancreatic Neoplasms; Pancreatolithiasis
• Interventions: Procedure: Magnetic Compressive Anastomosis

• Registration Number: NCT03792048
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-01-01
• Study First Posted: 2019-01-03
• Study Start: 2019-02-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Compressive Anastomosis	Magnetic Compressive Anastomosis	A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

Primary Outcome Measures

Name	Time	Method
Incidence of anastomotic fistula	1 month post operation	Incidence of biliary or pancreatic fistula after surgery

Secondary Outcome Measures

Name	Time	Method
Length of bilio-/pancreaticojejunostomy time	during operation	Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
Hospitalization cost	1 to 4 weeks postoperation	cost in hospital
Incidence of pancreaticojejunostomic stricture	12 months post operation	Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
average length of postoperative hospital stay	1 to 4 weeks postoperation	length of hospital stay (days) after surgery
incidence of biliojejunostomic stricture	12 months post operation	Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up

Trial Locations

Locations (2)

First Affiliated Hospital of Xian JiaotongUniversity; 🇨🇳 Xi'an, Shaanxi, China

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