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

Primary Purpose

Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic Compressive Anastomosis
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring bilioenteric anastomosis, pancreaticojejunostomy, Magnetic Compressive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xian JiaotongUniversityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Magnetic Compressive Anastomosis

Manual Anastomosis

Arm Description

A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy

Outcomes

Primary Outcome Measures

Incidence of anastomotic fistula
Incidence of biliary or pancreatic fistula after surgery

Secondary Outcome Measures

Length of bilio-/pancreaticojejunostomy time
Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
average length of postoperative hospital stay
length of hospital stay (days) after surgery
Hospitalization cost
cost in hospital
incidence of biliojejunostomic stricture
Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Incidence of pancreaticojejunostomic stricture
Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up

Full Information

First Posted
December 12, 2018
Last Updated
November 15, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03792048
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms, Pancreatolithiasis, Chronic Pancreatitis
Keywords
bilioenteric anastomosis, pancreaticojejunostomy, Magnetic Compressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Compressive Anastomosis
Arm Type
Experimental
Arm Description
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
Arm Title
Manual Anastomosis
Arm Type
No Intervention
Arm Description
Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy
Intervention Type
Procedure
Intervention Name(s)
Magnetic Compressive Anastomosis
Intervention Description
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
Primary Outcome Measure Information:
Title
Incidence of anastomotic fistula
Description
Incidence of biliary or pancreatic fistula after surgery
Time Frame
1 month post operation
Secondary Outcome Measure Information:
Title
Length of bilio-/pancreaticojejunostomy time
Description
Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
Time Frame
during operation
Title
average length of postoperative hospital stay
Description
length of hospital stay (days) after surgery
Time Frame
1 to 4 weeks postoperation
Title
Hospitalization cost
Description
cost in hospital
Time Frame
1 to 4 weeks postoperation
Title
incidence of biliojejunostomic stricture
Description
Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Time Frame
12 months post operation
Title
Incidence of pancreaticojejunostomic stricture
Description
Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
Time Frame
12 months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Lv, MD,PHD
Phone
0086-13991200581
Email
luyi169@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xu-Feng Zhang, MD, PhD
Phone
86-29-85323626
Email
xfzhang125@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Lv, MD, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Lv, MD，PHD
Phone
0086-13991200581
Email
luyi169@126.com
First Name & Middle Initial & Last Name & Degree
Zhe Feng, MD
Phone
0086-17749083602
Email
624779797@qq.com
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu-Feng Zhang, MD, PhD
Phone
86 29 85323900
Email
xfzhang125@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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