NCT03749005

Brief Summary

The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for Pancreatic Cancer.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 18, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

November 21, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

November 19, 2018

Last Update Submit

November 19, 2018

Conditions

Keywords

Pancreatic CancerThree-dimensional Visualization

Outcome Measures

Primary Outcomes (1)

  • Impact on operation strategy of three dimensional visualization technique

    Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.

    30 days

Secondary Outcomes (2)

  • Impact on complication of three dimensional visualization technique

    30 days

  • 1-year disease free survival rate

    12 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with Pancreatic Cancer.

You may qualify if:

  • years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer. 3.Primary Pancreatic Cancer without metastasis. 4.The patients are volunteered for the study.

You may not qualify if:

  • Patients with mental illness.
  • Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
  • The patients refused to take part in the study.
  • There are other co-existed malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of The Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (2)

  • Wu X, Wang D, Xiang N, Pan M, Jia F, Yang J, Fang C. Augmented reality-assisted navigation system contributes to better intraoperative and short-time outcomes of laparoscopic pancreaticoduodenectomy: a retrospective cohort study. Int J Surg. 2023 Sep 1;109(9):2598-2607. doi: 10.1097/JS9.0000000000000536.

  • Tao H, Zeng X, Lin W, Wang Z, Lin J, Li J, Qian Y, Yang J, Fang C. Indocyanine green fluorescence imaging to localize insulinoma and provide three-dimensional demarcation for laparoscopic enucleation: a retrospective single-arm cohort study. Int J Surg. 2023 Apr 1;109(4):821-828. doi: 10.1097/JS9.0000000000000319.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Chihua Fang, M.D.;Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

April 18, 2017

Primary Completion

April 30, 2020

Study Completion

August 30, 2020

Last Updated

November 21, 2018

Record last verified: 2018-04

Locations