Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma

NCT03132649 | Unknown

• 1 other identifier: 201701
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 hilar cholangiocarcinoma.

Conditions

Hilar Cholangiocarcinoma

Keywords

Three dimensional visualization; Operation strategy

Outcome Measures

Primary Outcomes (2)

• 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.

  2 year

• Impact on complications of three-dimensional visualization technique

  The complications are refer to the classification of Clavien-Dindo, including postoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complications (number) will be recorded.

  2 year

Secondary Outcomes (10)

• Blood routine examination (the 1th, 3 th, 5th, 7th)

  2 year

• Urine routines (the 1th, 3 th,5th, 7th)

  2 year

• Stool Routine (the 1th, 3 th,5th, 7th)

  2 year

• Blood biochemistry (the 1th, 3 th,5th, 7th)

  2 year

• Tumor marker

  2 year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with hilar cholangiocarcinoma

You may qualify if:

• years≤ Age ≤70 years
• Complying with the diagnosis criteria of hilar cholangiocarcinoma.
• Without intrahepatic or extrahepatic extensive cancer metastasis.
• Preoperative serum bilirubin ≤51.3 umol/L or preoperative serum bilirubin \< 200 umol/L after the drainage by PTCD(percutaneous transhepaticcholangial drainage)/ENBD(endoscopic nasobiliary drainage).
• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimen will be comformed by histopathological examination

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 28, 2017
• Study Start: March 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)