Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Neoplasms Pancreatitis, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Magnetic group

Magnetic anastomosis for pancreaticojejunostomy

Intervention Type PROCEDURE

Magnetic anastomosis for pancreaticojejunostomy

Control group

Traditional hand-sewn for pancreaticojejunostomy

Traditional hand-sewn anastomosis

Intervention Type PROCEDURE

Traditional manual anastomosis for pancreaticojejunostomy

Interventions

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Magnetic anastomosis for pancreaticojejunostomy

Intervention Type PROCEDURE

Traditional hand-sewn anastomosis

Traditional manual anastomosis for pancreaticojejunostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No