Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis (MCTPIA)

November 10, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Magnetic group
Magnetic anastomosis for pancreaticojejunostomy
Procedure: Magnetic anastomosis for pancreaticojejunostomy
Magnetic anastomosis for pancreaticojejunostomy
Control group
Traditional hand-sewn for pancreaticojejunostomy
Procedure: Traditional hand-sewn anastomosis
Traditional manual anastomosis for pancreaticojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula
Time Frame: From date of surgery to one month postoperatively
Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity.
From date of surgery to one month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic stricture
Time Frame: one year from the date of surgery
Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations
one year from the date of surgery
Discharge of the magnets
Time Frame: 3 months from the date of surgery
X-ray plain film is performed regularly to check the movement and discharge of the magnets
3 months from the date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Yi Lv, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

January 31, 2022

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 10, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2015-001-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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