A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.

October 30, 2019 updated by: Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

The objectives of the study are as follows:

  1. To evaluate the perioperative safety of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.
  2. To demonstrate the prognosis of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Wenhui Lou, Ph.D.
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
          • Boyong Shen, Ph.D.
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital Affiliated to Naval Medical University
        • Contact:
          • Gang Jin, Ph.D.
      • Shanghai, Shanghai, China, 20092
        • Recruiting
        • Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with unknown chemotherapy sequence or status
  2. Patients with history of previous malignant tumors
  3. Patients with distant metastases

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 5 years
The overall survival data were defined by (date of recurrence/progression)-(date of surgery).During follow-up period, abdominal enhanced CT, chest X-ray, tumor markers and routine blood tests were carried out to evaluate recurrence/progression.
5 years

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital
Ruijin Hospital

Investigators

  • Principal Investigator: Yingbin Liu, Ph.D., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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)

January 1, 2008

Primary Completion (Actual)

October 31, 2018

Study Completion (Anticipated)

October 31, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETMEFP_LYB_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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