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

Zhujiang Hospital300 enrolled

Overview

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.

Because of the complexity of hilar cholangiocarcinoma,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 hilar cholangiocarcinoma.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Hilar Cholangiocarcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years≤ Age ≤70 years 2. Complying with the diagnosis criteria of hilar cholangiocarcinoma. 3. Without intrahepatic or extrahepatic extensive cancer metastasis. 4. 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). 5. 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.

Locations (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 year

Secondary Outcomes

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

Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)

Time frame: 2 year

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

Urine specific gravity, urine protein(mg/dl), urine sugar(mmol/L), leukocytes in urine(number/ul), urine erythrocyte(number/ul)

Time frame: 2 year

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

Defecate occult blood test, Microorganisms (mold, parasites, etc.)

Time frame: 2 year

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

Serum albumin(g/L), serum pre-albumin(g/L), serum globulin(g/L), total bilirubin(µmol/L), direct bilirubin(µmol/L),serum glutamic-oxaloacetic transaminase (AST, IU/L), serum glutamic pyruvic transaminase (ALT, IU/L), alkaline phosphatase (ALP, IU/L), gamma glutamyl transpeptidase（r-GGT, IU/L） ,Serum creatinine(µmol/L), Urea(mmol/L), Blood sugar(mmol/L)

Data from ClinicalTrials.gov

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