Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749005
• Other study ID #: 201801
• Status: Recruiting
• Start date: April 18, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: April 2018
• Source: Zhujiang Hospital
• Contact: Chihua Fang, M.D.;Ph.D
• Phone: (+86)2062782568
• Email: s_mountain[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2020
• Est. primary completion date: April 30, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1.18 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.

Exclusion Criteria:

1. Patients with mental illness.

2. 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.)

3. The patients refused to take part in the study.

4. There are other co-existed malignant tumors.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	Zhujiang Hospital of The Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact on complication of three dimensional visualization technique	The early postoperative complication and mortality are defined as the event observed within 30 days after surgerypostoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.	30 days
Secondary	1-year disease free survival rate		12 months