Pancreas AdenocarcinomaNCT04147403
A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.
An observational study of Pancreas Adenocarcinoma, run by Shanghai Jiao Tong University School of Medicine at 4 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Adenocarcinoma
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2008to 31 Oct 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.
- Patients with accessible medical records
Who cannot join
- Patients with unknown chemotherapy sequence or status
- Patients with history of previous malignant tumors
- Patients with distant metastases
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Boyong Shen, Ph.D.
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Wenhui Lou, Ph.D.
- Recruiting
Changhai Hospital Affiliated to Naval Medical University
Shanghai, Shanghai Municipality, 200433
Gang Jin, Ph.D.
- Recruiting
Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 20092
Yingbin Liu, Ph.D., +8613918803900, laoniulyb@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Jan 2008
- Primary completion31 Oct 2018
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yingbin Liu, Ph.D., Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147403
- Sponsor's protocol ID
- ETMEFP_LYB_2019
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
- ClinicalTrials.gov ID
- NCT04147403
- Acronym / sponsor ID
- ETMEFP_LYB_2019
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Zhongshan Hospital
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.
- Patients with accessible medical records
Key exclusion criteria (3 listed)
- Patients with unknown chemotherapy sequence or status
- Patients with history of previous malignant tumors
- Patients with distant metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Disease free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingbin Liu, Ph.D. principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma, run by Shanghai Jiao Tong University School of Medicine at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingbin Liu, Ph.D. (+8613918803900, laoniulyb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.