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

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 Overview

• Status: Unknown
• Conditions: Hilar Cholangiocarcinoma

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang hospital of southern medical university
      • Contact: Chihua Fang, MD; Phone Number: (+86)2062782568; Email: s_mountain@126.com
      • Contact: Qingshan Chen, MM; Phone Number: (+86)2062782568; Email: s_mountain@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients with hilar cholangiocarcinoma

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood routine examination (the 1th, 3 th, 5th, 7th)	Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)	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)	2 year
Stool Routine (the 1th, 3 th,5th, 7th)	Defecate occult blood test, Microorganisms (mold, parasites, etc.)	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)	2 year
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
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
Inflammatory biomarkers	C-reactive protein, procalcitonin	2 year
Preoperative viral loading	HBV(hepatitis B virus)- DNA、HCV(hepatitis C virus)- RNA	2 year
Postoperative results of paraffin wax and immunohistochemical index	CK7、CK18、CK19、Hepatocyte、CD34（vascular）、S-100（nerve）、D2-40（lymphatic）、AFP、Ki67	2 year
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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Three dimensional visualization; Operation strategy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: 201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No