Clinical trial NCT03792048: Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure
Official title: Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma
Pancreatic Neoplasms
Duodenal Neoplasms
Pancreatolithiasis
Chronic Pancreatitis
Keywords: bilioenteric anastomosis
pancreaticojejunostomy
Magnetic Compressive
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of anastomotic fistula
timeFrame: 1 month post operation
Secondary outcomes:
measure: Length of bilio-/pancreaticojejunostomy time
timeFrame: during operation
measure: average length of postoperative hospital stay
timeFrame: 1 to 4 weeks postoperation
measure: Hospitalization cost
timeFrame: 1 to 4 weeks postoperation
measure: incidence of biliojejunostomic stricture
timeFrame: 12 months post operation
measure: Incidence of pancreaticojejunostomic stricture
timeFrame: 12 months post operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yi Lv, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: