NCT03780946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

December 12, 2018

Last Update Submit

November 10, 2019

Conditions

Pancreatic NeoplasmsPancreatitis, Chronic

Keywords

magnamosis; magnetic anastomosis; pancreaticojejunostomy

Outcome Measures

Primary Outcomes (1)

  • Pancreatic fistula

    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 Outcomes (2)

  • Anastomotic stricture

    one year from the date of surgery

  • Discharge of the magnets

    3 months from the date of surgery

Study Arms (2)

Magnetic group

Magnetic anastomosis for pancreaticojejunostomy

Procedure: Magnetic anastomosis for pancreaticojejunostomy

Control group

Traditional hand-sewn for pancreaticojejunostomy

Procedure: Traditional hand-sewn anastomosis

Interventions

Magnetic anastomosis for pancreaticojejunostomyPROCEDURE

Magnetic anastomosis for pancreaticojejunostomy

Magnetic group
Traditional hand-sewn anastomosisPROCEDURE

Traditional manual anastomosis for pancreaticojejunostomy

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatitis, Chronic

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Yi Lv, MD, PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lv Yi, MD, PhD

CONTACT

86-29-85323900luyi169@126.com

Xu-Feng Zhang, MD, PhD

CONTACT

86-29-85323626xfzhang125@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 19, 2018

Study Start

February 1, 2019

Primary Completion

January 31, 2021

Study Completion

January 31, 2022

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

CN(1)