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

• Conditions: Pancreatic Cancer

• Registration Number: NCT03749005
• Lead Sponsor: Zhujiang Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-18
• Status Verified: 2018-04
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-21
• Primary Completion: 2020-04-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact on operation strategy of three dimensional visualization technique	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Impact on complication of three dimensional visualization technique	30 days	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.
1-year disease free survival rate	12 months

Trial Locations

Locations (1)

Zhujiang Hospital of The Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China