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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT04147403

Collaborator

Ruijin Hospital (Other), Shanghai Zhongshan Hospital (Other)

200

Enrollment

Locations

154

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Adenocarcinoma

Detailed Description

The objectives of the study are as follows:

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Oct 31, 2018

Anticipated Study Completion Date :

Oct 31, 2020

Outcome Measures

Primary Outcome Measures

Overall survival [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.

Secondary Outcome Measures

Disease free survival [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200025
2	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
3	Changhai Hospital Affiliated to Naval Medical University	Shanghai	Shanghai	China	200433
4	Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai	China	20092

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
Shanghai Zhongshan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yingbin Liu, MD, PhD, FACS, Prof., Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04147403

Other Study ID Numbers:

ETMEFP_LYB_2019

First Posted:

Nov 1, 2019

Last Update Posted:

Nov 1, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yingbin Liu, MD, PhD, FACS, Prof., Shanghai Jiao Tong University School of Medicine

pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Nov 1, 2019