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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04147403
Other study ID # ETMEFP_LYB_2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date October 31, 2020

Study information

Verified date October 2019
Source Shanghai Jiao Tong University School of Medicine
Contact Yingbin Liu, Ph.D.
Phone +8613918803900
Email laoniulyb@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 31, 2020
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Changhai Hospital Affiliated to Naval Medical University Shanghai Shanghai
China Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Ruijin Hospital, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Disease free survival 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
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