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

Hilar Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132649
• Other study ID #: 201701
• Status: Recruiting
• First received: April 9, 2017
• Last updated: April 17, 2018
• Start date: March 15, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2018
• Source: Zhujiang Hospital
• Contact: n/a
• 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 hilar cholangiocarcinoma.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Klatskin Tumor

Locations

Country	Name	City	State
China	Zhujiang Hospital of 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.	2 year
Primary	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	Blood routine examination (the 1th, 3 th, 5th, 7th)	Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)	2 year
Secondary	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)	2 year
Secondary	Stool Routine (the 1th, 3 th,5th, 7th)	Defecate occult blood test, Microorganisms (mold, parasites, etc.)	2 year
Secondary	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)	2 year
Secondary	Tumor marker	Alpha fetoprotein(AFP, ng/L), Carbohydrate antigen-199(CA-199, ku/L), Carbohydrate antigen-125(CA-125, ku/L), Carcinoembryonic antigen (CEA, ng/L), Carbohydrate antigen-153(CA-153, ku/L)	2 year
Secondary	The blood coagulation function (the 1th, 3th, 5th, 7th)	prothrombin time (PT, s), partial thromboplastin time (APTT), international normalized ratio (INR), plasma prothrombin activity (PTA, %), fibrinogen (FIB, g/L), d—dimer(mg/L)	2 year
Secondary	Inflammatory biomarkers	C-reactive protein, procalcitonin	2 year
Secondary	Preoperative viral loading	HBV(hepatitis B virus)- DNA?HCV(hepatitis C virus)- RNA	2 year
Secondary	Postoperative results of paraffin wax and immunohistochemical index	CK7?CK18?CK19?Hepatocyte?CD34(vascular)?S-100(nerve)?D2-40(lymphatic)?AFP?Ki67	2 year
Secondary	Postoperative pathologic examination	The stage of TNM, The condition of resection (R0/R1/R2), the condition of liver cirrhosis, the pathological type of the tumor (Nipple type/nodule type/infiltration type)	2 year