Clinical trial NCT03780946: Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis
Official title: Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Pancreatitis, Chronic
Keywords: magnamosis; magnetic anastomosis; pancreaticojejunostomy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients with pancreatic neoplasm who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy.
2. Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs Frey's procedure.
3. Patients with pancreatic injury who needs pancreatic head resection, or central pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy.
4. Patients who are willing to join this clinical trial and informed consent form voluntarily.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pancreatic fistula
timeFrame: From date of surgery to one month postoperatively
Secondary outcomes:
measure: Anastomotic stricture
timeFrame: one year from the date of surgery
measure: Discharge of the magnets
timeFrame: 3 months from the date of surgery
Other outcomes:
Locations:
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: