NCT04147403

Brief Summary

The study of extended total mesopancreas excision(eTME) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

January 1, 2008

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

10.8 years

First QC Date

October 30, 2019

Last Update Submit

October 30, 2019

Conditions

Pancreas Adenocarcinoma

Keywords

pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The overall survival data were defined by (date of death)-(date of first diagnosis).The survival status of patients were retrieved from follow-up.

    5 years

Secondary Outcomes (1)

  • Disease free survival

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with resectable pancreatic head adenocarcinoma who underwent radical resection between January 1st 2008 and October 31st 2018 in collaborated tertiary hospital hospitals.

You may qualify if:

  • Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.
  • Patients with accessible medical records

You may not qualify if:

  • Patients with unknown chemotherapy sequence or status
  • Patients with history of previous malignant tumors
  • Patients with distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Changhai Hospital Affiliated to Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 20092, China

RECRUITING

Study Officials

  • Yingbin Liu, Ph.D.

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingbin Liu, Ph.D.

CONTACT

+8613918803900laoniulyb@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

January 1, 2008

Primary Completion

October 31, 2018

Study Completion

October 31, 2020

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)